- Hybrid trial model enhances participant access, retention, and enrollment efficiency across underserved and rural communities -

POTOMAC, MD / ACCESS Newswire / January 12, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage pharmaceutical company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced the addition of Dominion Medical Associates, Inc., a Richmond, Virginia-based clinical research site within Lightship's site network, to the Company's Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease.

Dominion Medical Associates will operate under Lightship's expanded access clinical trial model, combining in-clinic assessments with remote and in-home participant activities as part of a flexible hybrid and virtual delivery approach. This participant-centric approach is designed to expand access, reduce burden, improve retention, and enhance trial efficiency. Dominion Medical Associates is led by Founder and Principal Investigator Dr. Richard Allen Jackson, and Director of Clinical Research Richard "AJ" Jackson.

"The addition of Dominion Medical Associates represents a meaningful step forward in expanding access to our CALMA trial," said Ram Mukunda, CEO of IGC Pharma. "Their hybrid model aligns with our strategy to reach patients in underserved and rural communities while maintaining high-quality clinical oversight and data integrity."

Advancing Enrollment Through Hybrid and Flexible Site-Based Trial Design

Dominion Medical Associates, as part of Lightship's site network, uses a hybrid model that allows certain trial activities to take place in participants' homes. This model offers several key advantages:

Broader participant access, including individuals in more remote locations and those with limited ability to travel.

Improved convenience that supports retention throughout the trial.

Scalability across multiple regions, enabling greater participant diversity and more robust data.

To support the remote components of the trial, Dominion Medical Associates partners with Lightship to deliver hybrid and virtual study visits, supported by trained mobile research nurses, validated technology solutions, and centralized clinical support. Through this approach, remote and in-home study visits are coordinated and conducted with consistent investigator oversight, maintaining protocol adherence, data integrity, and regulatory compliance while extending research participation beyond traditional clinic settings.

"Hybrid clinical trials represent the future of participant-centered research," Mukunda added. "By integrating experienced clinical sites with on-site, hybrid, and virtual visit models, we believe IGC Pharma can accelerate enrollment while maintaining rigorous clinical standards."

IGC-AD1 is a cannabinoid-based investigational therapy currently being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial for agitation associated with Alzheimer's disease. The continued expansion of the CALMA clinical network across the United States reflects IGC Pharma's commitment to efficient trial execution, patient diversity, and timely study completion. This approach leverages community-based clinical sites and flexible visit options to extend research participation beyond traditional clinic settings.

To learn more about the trial and participation, visit: Link.

IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.

Lightship is a modern clinical trial site organization committed to making research participation possible for all. We collaborate with biopharma and CROs to design and conduct studies that expand access and choice while accelerating new therapies. Through in-clinic, at-home, and mobile research unit visits, we support participants from first contact to completion and deliver shorter timelines, stronger retention, greater diversity, and consistent quality and safety. At Lightship, we redefine what it means to be a clinical trial site.

This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Rosalyn Christian / John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200

As part of this study evaluating IGC-AD1 for agitation in Alzheimer’s disease, Dominion Medical Associates will operate under the Lightship expanded access site model, combining in-clinic assessments with hybrid, virtual, and in-home visits. This flexible approach is designed to reduce burden for participants and caregivers, improve retention, and expand access to research for individuals who may otherwise face barriers to participation.

IGC Pharma Expands Phase 2 CALMA Trial with New Clinical Site at Dominion Medical Associates, a Lightship Network Site, in Richmond, Virginia

Lightship’s Strategy Begins With Expanded Access

Clinical research is still finding its footing after the swings of the last few years. During the pandemic, teams leaned heavily on virtual solutions to keep studies moving while social distancing was in place. As those requirements eased, the industry shifted back toward familiar brick-and-mortar models with long-established oversight processes. Today, most organizations are somewhere in the middle. Sponsors want safe, low-risk innovation, participants want research that fits into their daily lives, and everyone is trying to balance quality with practicality.

This balance is where Lightship’s expanded access site model sits. Our approach starts with a simple question: how easy is it for someone to join and stay in a trial?

For many people, the honest answer is: not very. For full-time workers, caregivers, or anyone who lives far from a site or in a congested metro area, a clinic-only model turns each visit into a logistical hurdle. Rather than forcing trials into a single delivery approach, Lightship offers a set of options that flex around real lives: in-clinic visits at trusted sites, home and community visits supported by mobile nurses and mobile research units (MRUs), and virtual oversight where it’s safe and appropriate.

The same expanded access model that opens the door for participants also gives sponsors a practical way to move along the innovation curve at their own pace. In Darcy Forman’s recent piece, we explored how a three-pillar approach can de-risk a study by matching each visit to the right setting. In this article, we take the next step: how that philosophy shapes our go-to-market strategy, how it shows up in enrollment and retention, and what it means for sponsors that want one trusted partner for the full patient journey.

Most people come to clinical research while actively managing a health condition. They’re looking for better treatment options at the same time they’re juggling work, school drop-offs, caregiving, and everything else in their lives. Traditional clinic-only models often assume people can easily participate, when in reality each visit can mean unpaid time off, new childcare arrangements, and a long trip to a site.

Those demands add up and help explain why many people express interest but never book a first visit, or withdraw once participation collides with daily life. When every appointment requires repeated travel to a clinic during business hours, trials tend to enroll people with flexible schedules, strong support systems, and more resources. Others, no matter how highly motivated, are effectively shut out.

Lightship’s expanded access model is built to remove as much of that friction as possible. By offering in-clinic, hybrid, and at-home options under one coordinated framework, we can adapt visit schedules and locations to real life instead of asking participants to rearrange their lives around the protocol. For some, that might mean in-clinic visits for complex procedures and home visits for routine safety checks. For others, it might mean evening visits after work, or meeting at an MRU parked in a familiar community setting.

One of our nurses described a recent cystic fibrosis study that brought our concept to life. The participant was a young woman whose daily routine reflected the progress of modern cystic fibrosis (CF) care. She worked full-time, lived with friends, and managed her condition with confidence. The protocol for this study required frequent pharmacokinetic (PK) blood draws. In a traditional model, she would have needed to take repeated time off and commute across a busy city several times a week just to stay on schedule.

Instead, the trial came to her. The nurse conducted many of the required visits in the participant’s home during evening hours, coordinating with the rest of the study team to keep every procedure aligned with the protocol. The participant could finish her workday, keep her routine, and still contribute to a study with real potential to help others living with CF. She told the team that without that flexibility, she would not have been able to stay in the trial.

From our nurse’s perspective, this was a concrete example of how choice preserves engagement and trust. When the study model respects someone’s time, responsibilities, and safety, they’re far more likely to remain involved through the last visit. It’s a key reason Lightship’s retention rates are around 95% across many studies. Expanded access doesn’t lower our expectations of participants; it gives them a fair chance to meet those expectations without sacrificing the rest of their lives.

Choice matters just as much for sponsors and CROs as it does for participants. Lightship’s expanded access site model is built to support the full range of trial delivery through a single partner, so teams aren’t locked into a single way of running a study or forced to layer on new vendors every time they add flexibility. Complex procedures stay in-clinic, routine safety checks can move into the home, and long-term follow-up can rely on virtual visits when appropriate. One coordinated framework supports all three, so teams can design around protocol and patient while streamlining the number of external providers they need to manage.

Across comparable studies, Lightship has enrolled at least three times more participants than traditional brick-and-mortar sites in similar timeframes. That performance is driven by a few levers working together:

Investigators draw on EMRs and existing patient relationships.

Our teams collaborate with tech-agnostic recruitment partners when needed.

MRUs create community-based awareness, education, and prescreening that would never happen inside clinic walls alone.

Together, these channels extend reach while reducing the number of separate vendors and handoffs sponsors have to oversee..

Startup performance follows the same pattern. Because site services, home nursing, and virtual oversight sit under one organization and one SOP structure, Lightship typically moves from site identification to site initiation in less than eight weeks, with some studies activating in as few as four.

Quality and oversight underpin everything. Lightship has completed more than thirty audits with zero critical findings and has engaged with the FDA twice. Investigators, MRU staff, home nurses, and coordinators all work from unified SOPs, so oversight stays consistent across settings. For sponsors and CROs, that combination of flexibility, measurable performance, and high quality turns choice into a risk-conscious strategy rather than a variable to manage.

One Trusted Partner for the Entire Patient Journey

For sponsors and CROs, the value of this approach is having one coordinated partner that can carry a participant from first contact through the last visit, across different settings, without losing continuity.

In traditional models, adding flexibility often means adding vendors, each with its own contracts, SOPs, and handoffs. A site manages in-clinic visits. An external nursing agency handles home visits. Separate technology platforms run telemedicine and participant outreach. On paper, it looks like choice, but in practice, sponsors inherit more interfaces, more risk, and more work.

With Lightship’s expanded access model, sponsors get one organization that provides in-clinic site services, home and community visits, MRUs, and virtual oversight. Investigators, coordinators, and nurses operate within one SOP framework, supported by the technology platforms a sponsor is already using. Oversight travels with the participant, whether they're at a brick-and-mortar site, at home, or at an MRU in the community.

For sponsors, that means they can plan around one set of relationships and one quality system instead of stitching together a patchwork of providers. For participants, it means they see a consistent team across settings, which builds trust and lowers the barrier to staying engaged.


Flexible Models Can Be Innovative and Practical

Lightship’s strategy starts with a straightforward idea: design around the lives of participants and the comfort level of sponsors, then give both groups real choices in how research is delivered. In-clinic, hybrid, and virtual models all sit inside one expanded access framework. Our metrics (higher enrollment, strong retention, and faster startup) show what sponsors stand to gain.

In our experience, expanded access models are fundamentally practical. They increase the chances that the right participants can join and stay in a study, and help teams meet enrollment goals and study timelines without sacrificing quality or oversight. And, by relying on one trusted partner that can flex across settings, sponsors can support the full patient journey while keeping quality at the center.

The result is straightforward: trials move forward with fewer barriers between intent and impact.

Clinical research shouldn’t force participants to rearrange their lives to take part, but expanded access is reshaping study delivery for both participants and sponsors. By offering in-clinic, at-home, hybrid, and community-based options under one coordinated framework, Lightship is helping teams enroll more efficiently, retain participants at ~95%, and maintain high-quality oversight—all while giving people real choice in how they take part.

Designing Trials Around Real Life: The Operational Benefits of Expanded Access Site Models

In this edition of our “Meet the Team” blog series, we’re excited to spotlight Taylor Tanner, Senior Manager of Clinical Trial Design. Taylor plays a key role in shaping how studies come to life at Lightship, helping to determine where and how visits occur (in-clinic, at home, on our mobile research unit [MRU], or through telemedicine), so participants have options that fit their daily lives. Taylor helps ensure that every study reflects Lightship’s mission.

We’re so happy to speak with you, Taylor! Tell us, how long have you been with Lightship? What brought you here?

I’ve been with Lightship for 4.5 years, and the time has truly flown by. I first learned about the company through a former colleague whom I deeply respect, and I was immediately drawn to Lightship’s mission of expanding access to clinical trials, making participation possible regardless of geography or daily commitments. It’s been an incredible journey, and I’m proud to contribute to work that makes a meaningful impact.

What does a typical day in your role look like?

In my role, I evaluate study protocols to determine the most effective Lightship delivery model: site-based, hybrid, or virtual. This assessment incorporates study requirements, participant population considerations, sponsor objectives, and input from our clinical operations team. Our goal is to design an approach that supports quality and consistency while giving participants meaningful options in how they take part.


How does your work contribute to Lightship’s mission of making research participation possible for all?

By reviewing each assessment to identify visits that can be conducted outside of the site, we enhance flexibility and choice for participants, making trial participation more accessible. Options such as community-based visits on our MRU or in-home visits with a Lightship research nurse reduce time away from family and work, which improves the overall participant experience.


Can you share a moment or project at Lightship that made you feel particularly proud?

I’m proud to support Lightship’s annual Season of Giving initiative. Each year, as we celebrate the holiday season, our team comes together for a day of service, giving back to the communities where we live and work. This year, we’re focusing on organizations dedicated to fighting hunger, a cause that reflects our core values of Impact and Service.

What is your favorite part about working at Lightship?
There’s so much I appreciate about Lightship! First and foremost, our incredible team, dedicated to seamlessly supporting sponsors and studies while fostering a collaborative, enjoyable environment. It’s rare for a meeting to pass without a shared laugh or a dad joke! 


I also value the variety in our work. Every sponsor and study indication requires a tailored approach to meet participant needs. Ultimately, our efforts focus on improving lives by meeting participants where they are, regardless of mobility, health conditions, or life obligations.


Outside of work, I enjoy spending time with my husband and daughters, visiting national parks, exploring new restaurants, and proudly cheering on UNC basketball. Go Heels!

Thank you, Taylor, for sharing your story and for the thoughtful work you bring to every study design. Your commitment to expanding access and creating participant-centered experiences strengthens every trial we deliver. Stay tuned for our next “Meet the Team” highlight!


In this edition of our “Meet the Team” blog series, we’re excited to spotlight Taylor Tanner, Senior Manager of Clinical Trial Design. Taylor plays a key role in shaping how studies come to life at Lightship, helping to determine where and how visits occur, so participants have options that fit their daily lives. 

Meet the Team: Taylor Tanner, Senior Manager, Clinical Trial Design

In a recent episode of The Healthcare Technology Report podcast, Lightship CEO David MacMurchy spoke with host RJ Lumba about the company’s mission and the lessons he’s learned from a career spent with some of the industry's largest organizations. The conversation traces Lightship’s role in expanding access to clinical research, the structural barriers that persist for many communities, and the leadership principles guiding the company as it scales. 

Read the highlights from David’s conversation below.

Lightship’s flexible engagement model is expanding access by meeting patients where they are.
David begins by discussing Lightship’s core mission: to make it possible for all people to join clinical trials. By delivering flexible on-site, hybrid, and virtual trials, Lightship is able to reach participants that might not otherwise be able to take part in research due to their location, work, or family responsibilities. Mobile research units (MRUs) support all delivery models; Lightship parks these units in the community, such as retail parking lots or near local events. Staffed by Lightship nurses, MRUs can be paired with in-home visits to complete appropriate endpoints, which makes trial participation far more realistic for people juggling work and caregiving.

David notes that “by far and away, the most successful and most surprising part of the growth of the business has been recruiting by actually going into communities and meeting people where they are.” For example, nurses and staff attend Alzheimer’s walks and health fairs to talk directly with families who are curious about research. Those conversations flow into a growing database of participants, supported by partnerships with health systems, collaboration with local sites, and targeted digital outreach. According to David, because Lightship reaches participants who don’t live near traditional trial sites, its recruitment funnel is broader than a standard site model. This supports faster enrollment and strong completion, with a retention rate of 96%. Or, as David puts it simply, “[The model] works pretty well.”

Solving for structural inequities in clinical trial access and increasing representation
Lightship’s model is built to tackle the structural issues that keep many people out of research in the first place. David talks about the tight link between lower socioeconomic status and lack of access to clinical trials, and how that aligns with the long-standing underrepresentation of people of color in U.S. studies.

Time is a large barrier to participation; a burden compounded for those in large cities like Los Angeles or New York, where a few miles of travel can mean hours in traffic. For many people, taking time off work for repeated clinic visits simply isn’t possible. David says that even when someone is referred to a trial and expresses early interest, “they may sign up for it, but they never complete the study because it’s just too much of a burden on them.”

David says that by meeting people close to where they live and work through virtual, hybrid, and mobile visits, Lightship reduces that burden in a very practical way. Participants can stay in trials over several months or years without risking their jobs or income. That leads to better retention, more representative enrollment, and higher quality data that reflects the communities therapies are meant to serve.

David’s history, leadership, and a disciplined approach to scaling Lightship
David’s career across Pfizer, PRA Health Sciences, IQVIA, and Ernst & Young shaped how he thinks about building and scaling a company in a high-stakes environment. He saw how delayed or under-enrolled trials strain R&D teams and redirect budgets, which led him to a simple conclusion when founding Lightship: solving for access, enrollment, and retention delivers value for sponsors and better outcomes for participants.

Lightship’s growth strategy reflects that point of view. David emphasizes scaling in a way that protects quality because the team is delivering real clinical care. He notes that “[r]apid, rapid growth…it puts a risk on quality, and quality is central to what we do.” Lightship’s investors and leaders support that measured approach. As Lightship expands, Chief Operating Officer Darcy Forman and Chief Business Officer Michael Shipton play a central role. Both bring deep operational experience and a shared commitment to patient experience and thoughtful, sustainable growth, ensuring Lightship scales responsibly while staying grounded in its mission.

David’s leadership ethos sets the tone for this approach. He is candid about what he knows and what he is still learning, and he seeks partners who value transparency and honest problem-solving. Advice from mentors about finding purpose in the work continues to guide him, and for David, that purpose is clear: expanding access to research and improving outcomes for communities historically left out of clinical trials.

If you would like to learn more about Lightship’s model or explore partnership opportunities, we’re always open to a conversation. Visit www.lightship.com or reach out to our team to connect.

In a recent episode of The Healthcare Technology Report podcast, Lightship CEO David MacMurchy spoke with host RJ Lumba about the company’s mission and the lessons he’s learned from a career spent with some of the industry's largest organizations. The conversation traces Lightship’s role in expanding access to clinical research, the structural barriers that persist for many communities, and the leadership principles guiding the company as it scales. 

Expanding Clinical Trial Access: Lightship’s CEO David MacMurchy on The Healthcare Technology Report

In this installment of our “Meet the Team” blog series, we talk to Carrie Kibler, Clinical Research Nurse, about what it’s like to travel across the country supporting Lightship’s studies, why flexibility and organization are key in clinical research, and how she sees Lightship changing the participant experience.

Hi Carrie! Thanks for doing this. Let’s start with the basics. How long have you been with Lightship? What brought you here?

I’ve been with Lightship for a year and a half. What brought me here was the mission: being people-first and increasing access to clinical trials for all. I wanted to be part of a team that’s transforming how research reaches people.

A typical day for me involves contacting participants to complete consent or schedule visits, flying or driving across states to see them, carrying out nursing duties during visits or screenings, and staying meticulously organized to prepare for each one. I upload data to research portals, keep our study platforms and spreadsheets current, and make sure every visit has the materials and information needed.

Detail and organization are critical in research, especially for an in-home and travel-based model like ours. Every visit depends on preparation and precision.


How do you see Lightship transforming the clinical trial experience for participants?

Lightship’s expanded access clinical research model and the options it provides is essential today. Participants frequently face challenges getting to in-person sites between busy schedules, mobility issues or debilitating health conditions, and long travel distances. Lightship’s flexible model changes that. We meet participants where they are, whether at home, in clinics, or through mobile research units, making participation easier and more inclusive. As technology continues to advance and our medical equipment becomes increasingly smaller and mobile, I see only great things for Lightship’s participants.

What motivates or inspires you in your work?

What motivates me as a travel research nurse is bringing medical support and life-changing opportunities to everyone, regardless of their socioeconomic status or location. I also love seeing participants’ gratitude firsthand as they improve their own health and help pave the way for others.


What is your favorite part about working at Lightship?
My favorite part of Lightship is working with great, dedicated co-workers and getting to see different parts of the country along the way!

I enjoy resistance training and hanging out with family and my vizslas.


Thank you, Carrie, for sharing your story and for the role you play in supporting Lightship’s mission to make clinical research more accessible and people-centered. Stay tuned for our next “Meet the Team” feature!

Meet the Team: Carrie Kibler, Clinical Research Nurse

Forced innovation and a return to tradition

In early 2020, clinical research found itself in uncharted waters. Faced with the pandemic, sponsors, sites, and regulators had to pivot quickly. According to a report in The Lancet, around 80% of non-COVID-19 trials were stopped or interrupted. Innovation, therefore, wasn’t optional; it was the only way to keep research moving. Studies that once relied on clinic visits embraced telemedicine, remote monitoring, and direct-to-patient shipment of investigational product. 

But as the urgency of that moment faded, many organizations retreated to the familiar—returning to site-first workflows that feel easier to monitor, defend, and explain. The instinct is understandable. Familiar processes seem safer.

Yet risk lives in rigidity as much as novelty. Forcing every visit into a single delivery model—whether all in-clinic or all virtual—creates friction, adds unnecessary complexity, and ultimately makes trials harder to run.

A steadier, lower-risk path is to plan for choice. That’s the principle behind Lightship’s expanded access model: giving sponsors and participants in-clinic, hybrid, and virtual options, all managed under one roof. By meeting teams where they are on the innovation curve and offering participants flexible ways to engage, we reduce risk while expanding reach.

When teams commit to one delivery model too early, the plan starts driving the protocol instead of the other way around. Schedules of assessments rarely move in a straight line: a biopsy or imaging window sits next to a run of routine safety checks; a complex dose visit is followed by a quick adverse-event review. Treating every visit as if it needs the same setting forces unnecessary complexity somewhere, either by pulling simple tasks into the clinic or by stretching at-home methods past what’s been proven and practicable. Oversight becomes harder to defend, handoffs multiply, and participants feel the friction.

A steadier path is to design for choice from the start. Keeping all three options on the table allows sponsors to place each visit in the least complex acceptable setting—anchoring complex work in the clinic, shifting routine work when it can be done safely at home, and using telemedicine for what it does best: extending reach and continuity.

Trial delivery isn’t binary - traditional or innovative, on-site or virtual. Most protocols benefit from using more than one setting across the schedule of assessments. Each pillar in Lightship’s model represents a unique type of trial delivery, and each brings distinct value:

In-clinic (brick & mortar): The anchor for complex or invasive procedures, imaging, or anything requiring specialized equipment and immediate intervention. Lowest risk, highest familiarity.

Hybrid (clinic + home/telemedicine): This is the sweet spot for most protocols. Mobile nurses conduct blood draws, PK samples, vitals, and telemedicine-guided physicals in the home, while keeping complex work in-clinic. Evening and weekend visits reduce missed appointments.

Virtual (home/telemedicine with PI oversight): Best for long-term follow-ups, clinician-reported assessments that don’t require equipment-heavy procedures, and patient-reported outcomes. Ideal for extending reach to participants far from sites or constrained by schedules.

Additionally, each type of trial delivery can be supported by Lightship’s Mobile Research Unit (MRU), serving as an extension of a physical site as needed.

The working rule is simple: match the mode to the visit, not the study. Designing for choice keeps the protocol in the driver’s seat, reduces unnecessary complexity, and gives participants flexibility without sacrificing quality.

Quality and oversight—without contortions

In a three-pillar model, quality comes down to continuity and simplicity. Investigator oversight travels with the participant, regardless of the location. Technology underpins this continuity, providing a single backbone across in-clinic, hybrid, and virtual visits.

Consistency: The same PI and CRCs anchor oversight across settings. Whenever possible, the same nurse who sees a participant in the clinic can also support them at home, building trust, improving recall, and strengthening engagement.

Transparency: Clear delegation logs, standardized SOPs, and simple visit briefs make it obvious who saw what, who decided what, and what happened next. Shared technology platforms ensure those records are visible across all settings.

Integration: A unified technology backbone keeps oversight seamless, with real-time data capture, alerts, and documentation that follow the participant across settings. Weekly PI–staff reviews and automated triggers highlight issues such as missed PK windows, courier delays, reschedules early, so they can be addressed before they become patterns.

By combining trusted clinical relationships with a technology backbone that integrates across all three pillars—and is agnostic in order to plug into a sponsor’s existing platforms and workflows—oversight stays intact, quality is preserved, and every visit has the same oversight and quality regardless of modality.

Procurement and cost: where complexity hides

The building blocks of flexible research—sites, home nursing, telemedicine—already exist. Risk creeps in when they’re assembled piecemeal. Every new vendor adds contracts, start-ups, training, monitoring, and handoffs. Each on its own may be manageable; taken together, they widen timelines and create more places for something to stall.

By consolidating under one coordinated team, sponsors reduce redundant start-ups and avoid parallel systems. Lightship sites, home nurses, and virtual platforms operate under the same SOP framework, led by the same investigators. That consistency not only cuts down on contracts and vendor management burden—it also matters deeply to investigators. When study staff comes from within the Lightship team, investigators know and trust the nurses, are comfortable with delegation, and remain confident that oversight is preserved.

This is where many hybrid models have struggled. Investigators are often reluctant to delegate tasks to external nursing vendors who follow different SOPs and are unfamiliar, which limits adoption and undercuts the potential benefits of at-home support. In Lightship’s model, those barriers are minimized. The same team that anchors the study in-clinic also extends care into the home, ensuring adoption, quality, and continuity without compromise.

Mitigating risk also means scaling thoughtfully. Lightship begins at the state level,, where PIs and nurses hold licensure to oversee participants statewide. Starting here makes adoption easier for sponsors; an approach aligned with the industry’s innovation curve, where most teams prefer to take new models in measured steps.

Once the model is proven and quality demonstrated, sponsors gain the confidence to expand further. What begins as a state footprint can extend into national coverage, giving states broader reach without adding unnecessary risk.

This “prove and repeat” approach avoids overextension while showing a clear path to scale. Teams learn faster, start-up timelines shorten, and growth happens in a way that is steady, auditable, and ready to expand when sponsors are.

Of course, risk extends beyond data and oversight. Supporting participants’ ability to stay involved in a trial is key to managing risk. By giving participants choice, we remove barriers that often derail studies:

Parents don’t have to arrange childcare for routine visits.

Workers can schedule evening check-ins without taking time off.

Rural participants can join a trial without traveling hours to a clinic.

If a visit can be done at home safely and cleanly, offer that option alongside the clinic slot—especially for routine check-ins that fit after work or on weekends. These small flexibilities drive retention and broaden access. They also support the representation benchmarks tied to safety and efficacy analyses for approval. Ensuring trials reflect real-world populations is how we generate reliable, approvable data.

The industry doesn’t have to choose between innovation and tradition. The true low-risk path is planning for choice by offering in-clinic, hybrid, and virtual settings under one model, with consistent oversight and quality at the core.

Clinical trials succeed when sponsors and sites have the flexibility to put each visit in the right setting. Most importantly, this flexibility keeps people engaged, because research that fits into daily life is research that participants are able to complete. By meeting sponsors where they are on the innovation curve, and participants where they live, we expand access, reduce burden, and shorten timelines—without taking unnecessary risks. 

At Lightship, we believe options should be at the heart of every clinical trial. Our three-pillar site model—anchored in-clinic, extended through hybrid, and scaled virtually—makes participation easier, safer, and more inclusive. With one trusted partner, sponsors gain flexibility without added complexity.

Let’s design studies that de-risk the path forward—for sponsors, for participants, and for the therapies that need to reach patients faster. Learn more at www.lightship.com.

The industry doesn’t have to choose between innovation and tradition. In our latest blog, Lightship COO, Darcy Forman, shares how our expanded access site model—offering in-clinic, hybrid, and virtual options under one coordinated framework—reduces complexity, expands access, and keeps participants engaged while maintaining quality and oversight.

De-Risking Clinical Trials with an Expanded Access Site Model

In the first installment of our “Meet the Team” blog series, we talk to Tisha Hargrove, Senior Clinical Study Supply Coordinator, about the mission that drew her to Lightship, the moving parts behind a smooth study visit, and why access and choice matter for participants.


Hi Tisha! Thanks for doing this. Let’s start with the basics. How long have you been with Lightship? What brought you here?
I’ve been with Lightship for almost three and a half years. I was drawn to Lightship’s mission. By increasing access and choice, we improve enrollment, retention, and representation—and help bring effective therapies to people, faster.


What does a typical day in your role look like?
A typical day includes managing inventory operations: ordering supplies, receiving and inspecting shipments, performing quality control on study materials, shipping supplies to our nursing team for participant visits, and distributing general supplies for ongoing studies. I also handle key administrative and data tasks: reviewing and entering data for the Principal Investigator (PI), uploading study-related reports, sending physician orders, updating and resolving queries, and issuing payments for completed visits. It’s a lot of moving parts, but it means every visit has what it needs, when it needs it.


What excites you most about working in clinical research?
I get really excited about the chance to make a real difference in people’s lives. Every study is a step toward better treatments, earlier diagnoses, and even cures. It’s incredibly rewarding to be part of something that blends science, compassion, and innovation—all with the goal of helping others.

Also, clinical research is constantly evolving. New technologies, decentralized models, and patient-centered approaches are changing how we think about healthcare. Being at the forefront of that transformation keeps things fresh and meaningful.

How do you see Lightship transforming the clinical trial experience for participants?
Lightship makes it easier for people to take part in studies—no long trips required. We meet participants where they are: in-clinic, at home, virtually, or even through our mobile research unit (MRU). Joining a study fits into their life, not the other way around. Giving people choices like how and where visits happen can be the difference between dropping out and staying in a study. 


What do you enjoy doing outside of work?
I enjoy spending time with my family!

Thank you, Tisha, for sharing your story and the important role you play in supporting every study visit. Stay tuned for our next “Meet the Team” feature!

In the first installment of our “Meet the Team” blog series, we talk to Tisha Hargrove, Senior Clinical Study Supply Coordinator, about the mission that drew her to Lightship, the moving parts behind a smooth study visit, and why access and choice matter for participants.

Meet the Team: Tisha Hargrove, Senior Clinical Study Supply Coordinator

Morrisville, NC, August 28, 2025—Lightship Inc., the clinical research site organization dedicated to increasing access and choice for sponsors and participants, today announced its collaboration with The Society for Clinical Research Sites (SCRS) as a Global Impact Partner (GIP). As a GIP, Lightship will participate on the GIP Board, working closely with SCRS’ Leadership Council to champion sites within the global research marketplace. 

“Sites are the foundation of every clinical trial, and when sites are strong, participants and sponsors benefit,” said Michael Shipton, Chief Business Officer for Lightship. “We are thrilled to collaborate with SCRS as a Global Impact Partner and look forward to advancing site sustainability and enabling trials that are more inclusive, accessible, and effective for everyone involved.”

Through its commitment to making clinical research participation possible for all, Lightship offers a flexible, accessible site model that expands reach and helps bring new therapies to market faster. By meeting participants where they are—in brick-and-mortar clinics, in their own homes, and through mobile and virtual options—Lightship reduces barriers to enrollment while providing sponsors with reliable, high-quality delivery. This approach accelerates enrollment, strengthens retention, and improves representation through a single trusted partner. 

As a Global Impact Partner, Lightship will collaborate with SCRS leadership to shape industry best practices, advocate for greater site sustainability, and improve the research experience for both participants and sponsors.

“We are excited to welcome Lightship as a Global Impact Partner,” said Marcus Maleck, Vice President, Global Business Partnerships for SCRS. “Their flexible, patient-centered site model aligns with our mission to strengthen sites and expand access to research. Together, we can advance sustainability, equity, and collaboration across the global research community.”

To learn more about Lightship and how its site network model provides a seamless experience for sponsors and participants, visit www.lightship.com or follow the company on LinkedIn.

Lightship is a modern clinical trial site organization committed to making research participation possible for all. We collaborate with biopharma and CROs to design and conduct studies that expand access and choice while accelerating new therapies. Through in-clinic, at-home, and mobile research unit visits, we support participants from first contact to completion and deliver shorter timelines, stronger retention, greater diversity, and consistent quality and safety. At Lightship, we redefine what it means to be a clinical trial site. Learn more at www.lightship.com.

About the Society for Clinical Research Sites (SCRS) 

The Society for Clinical Research Sites (SCRS) is the leading advocacy organization dedicated to unifying the voice of the global clinical research site community. Representing more than 11,000 research sites in 50+ countries, SCRS facilitates industry collaborations and conversations dedicated to site-focused advocacy, education, mentorship, and connection. SCRS is an active and influential champion for sites in industry initiatives to ensure that the perspective of sites is heard and valued. Learn more and get involved at myscrs.org.  Our voice. Our community. Your success.

Contact: Brittany Kearns
Phone: 571-271-7211
Email: brittany@crossroadsb2b.com

The collaboration reflects a shared mission to amplify site sustainability and advance equity in clinical trial access.

Lightship Joins SCRS Global Impact Partner Program 

Circuit Clinical Solutions Inc. [“Circuit Clinical”] and Lightship Inc. [“Lightship”] Mutually Agree to Terminate Merger Agreement.

Circuit Clinical and Lightship today announced that they have mutually decided to terminate the previously announced merger agreement between the two companies. This decision was reached following careful consideration of recent developments and a thorough review of strategic priorities.

While both organizations entered the agreement with a shared vision for future growth and innovation, changes in market dynamics and evolving business needs have led to the conclusion that continuing independently is in the best interest of their respective stakeholders.

“We deeply value the relationship we’ve built with Lightship and are proud of the collaborative efforts made throughout this process,” said Dr. Irfan Khan, CEO of Circuit Clinical. “Circuit Clinical remains committed to driving value for shareholders and delivering best-in-class solutions to our customers.”

David MacMurchy, CEO of Lightship echoed the sentiment, stating, “Although our paths will diverge, we maintain great respect for the Circuit Clinical team and look forward to continued success in our individual journeys.”

The companies will continue to operate as separate entities and remain focused on their respective missions and long-term objectives.

About Circuit Clinical
Circuit Clinical, one of the fastest-growing research networks in the USA, is dedicated to empowering patients to choose clinical research as a care option through improved access to clinical trials. Committed to transforming the experience of finding, choosing, and participating in clinical research for physicians and their patients, Circuit provides clinical research services through traditional, hybrid, and decentralized community-based site models and their MD Prescreen service that optimizes patient referrals. Learn more at www.circuitclinical.com.   

About Lightship
Lightship is a clinical trials service provider focused on increasing access and ensuring research reflects representative populations. We partner with biopharma, CROs, and academic institutions to design and deliver studies that engage diverse and underserved patient groups, accelerating enrollment while improving patient access in clinical trials.   

Through targeted outreach and education, we connect with potential participants in their community, building trust and reducing barriers to enrollment. Our virtual and hybrid trial models, supported by our site network, mobile research units (MRUs), and mobile nursing, allow patients to participate in research that fits their lives, whether at home, in a clinic, or at an MRU in the community.   

By making trials more accessible and patient-centered, we reduce enrollment timelines, improve retention, and accelerate the development of therapies that better reflect real-world communities. Learn more about us at www.lightship.com.   

Contact:
Michael W. Shipton
Chief Commercial Officer, Lightship
mshipton@lightship.com | +1 919-605-8064

Circuit Clinical and Lightship today announced that they have mutually decided to terminate the previously announced merger agreement between the two companies.

Circuit Clinical and Lightship Mutually Agree to Terminate Merger Agreement

Discover how Lightship’s hybrid clinical trial model successfully accelerated enrollment for a Phase III cardiovascular study while expanding access, choice, and equity. Partnering with a top 10 global pharmaceutical company, Lightship leveraged its curated site network and experienced mobile research nurses to deliver a seamless trial experience that reduced patient burden and expanded reach.

By integrating in-clinic and off-site visits, Lightship enabled participation from individuals living over 60% farther from study sites than typical participants. This approach not only boosted enrollment capacity but also improved participant diversity - engaging more Black, African American, Hispanic, and Latino individuals than the national average for cardiology trials.

Through patient-centric design and strong operational alignment with site teams, Lightship ensured consistent oversight, high retention rates, and a smooth transition between visit modalities. The result was an accelerated recruitment timeline that exceeded sponsor goals and enhanced the overall participant experience.

How hybrid trial design expands reach and participant representation

The critical role of our site network and mobile nurses in accelerating enrollment

Strategies for enhancing diversity and retention

Key outcomes, including a 60% increase in participant distance and 95% retention for off-site visits

Hydrid Case Study.pdf

Download Hybrid Case Study

Discover How Lightship’s Curated Site Network and Mobile Research Nurses Accelerated Enrollment in a Phase III Cardiovascular Study

Circuit Clinical Solutions Inc. [“Circuit Clinical”] and Lightship Inc. [“Lightship”] Announce Strategic Merger to Accelerate Scale and Expanded Access in Clinical Research

Buffalo, NY & Morrisville, NC— Today, Lightship and Circuit Clinical proudly announce their strategic merger, forming a leading, unified force in clinical trial delivery. This landmark collaboration represents a significant step toward consolidating a fragmented industry—establishing a new standard for scale, accessibility, and innovation.

By uniting complementary capabilities, deep therapeutic expertise, and cutting-edge delivery models, the combined organization is purpose-built for growth and long-term impact. Bringing together Lightship’s leadership in hybrid trial models and mobile care with Circuit Clinical’s trusted community-based site network and patient engagement strengths, the new entity offers an integrated solution for sponsors, CROs, healthcare systems, and—above all—patients. Together, they are uniquely positioned to expand access, accelerate timelines, and enhance the overall clinical trial experience.

“Together, we’re redefining what’s possible in clinical research,” said David MacMurchy, CEO of Lightship. “This is an exciting milestone for our teams and for the industry as a whole.  Together, we will reframe what’s possible in clinical research—delivering greater value to sponsors and better outcomes for patients everywhere.”

“This merger is more than a business combination; it’s a bold response to the evolving needs of clinical research,” said Dr. Irfan Khan, CEO of Circuit Clinical. “Lightship plus Circuit Clinical delivers the scale, trust, and innovation needed to meet the growing complexity of modern trials”

Expanded Reach through physical site networks and remote delivery capabilities

Flexible Participation Models supporting traditional, hybrid, and fully virtual trials

Scalable, Professionally Managed Infrastructure that simplifies execution and accelerates patient enrollment

Streamlined Services that enhance the experience for investigators, health systems, sponsors, and CROs

By combining proven delivery models with top-tier operational talent, the merged company is setting a new bar for the future of clinical trials.

Mr. MacMurchy and Dr. Khan will serve as co-CEOs of the new organization. Both Circuit Clinical and Lightship will continue to operate under their existing brands during the transition. The combined company’s new name and identity will be announced in the coming weeks.

Media Contacts:
Michael W. Shipton
Chief Commercial Officer, Lightship
mshipton@lightship.com | +1 919-605-8064

Candice Kent
VP Marketing and Communications, Circuit Clinical
ckent@circuitclinical.com | +1 484-885-0981

Today, Lightship and Circuit Clinical proudly announce their strategic merger, forming a leading, unified force in clinical trial delivery.

Lightship’s MRUs bring clinical trials directly to participants, overcoming barriers and enhancing engagement. They offer a convenient, patient-focused approach to clinical trials in a trusted environment close to home.

With an experienced clinical team on board and customizable equipment tailored to each study’s needs, our MRUs deliver seamless care, from engagement and pre-screening to study visits and assessments in the community. Our units are fully equipped to collect biospecimen samples, store IMP under secure and temperature-controlled conditions, conduct ECGs, monitor vitals, perform physical exams, and support a wide range of clinical trial activities.

How MRUs help with community outreach - including targeted study outreach and long-term engagement; pre-screening; and study visits

Our collaborative approach to community outreach and the results that have stemmed from our workflow

Novel approaches to MRU incorporation to make your study a success

Lightship MRU Case Study.pdf

Download MRU Case Study

Mobile Research Units in Action: Discover how Lightship's MRUs bring clinical trials directly to communities, enhancing patient engagement and simplifying trial delivery.

David MacMurchy, Chief Executive Officer at Lightship, offers some insights into the company's mission toward improving equity and diversity in clinical trials.

Accelerate Inclusive Enrollment and Delivery with Lightship

Sepehr Shojaei, VP of Design Solutions at Lightship, talks about how the company works with pharma and contract research organization (CRO) partners to support clinical trials that are patient-first and accessible.

Lightship’s Approach to Accessible, Representative, and Impactful Clinical Trials

EL SEGUNDO, Calif., March 27, 2025 – Lightship Inc., a leading provider of community-based, decentralized clinical trial services, is pleased to announce the appointment of Michael Shipton as Chief Commercial Officer (CCO). With a proven track record of driving growth and innovation in the life sciences and technology sectors, Shipton will play a key role in reshaping Lightship’s go-to-market strategy and strengthening its ability to meet the growing complexity of representative clinical trials.

Shipton brings over 30 years of experience in designing and executing high-impact business solutions, with expertise across sales management and operations, marketing, strategic pricing and partnerships, finance, global operations, and customer engagement. As Lightship enters an exciting new phase of growth, his leadership will be essential in expanding the company’s service offerings and driving strategic business development efforts that will enable Lightship to meet the evolving needs of its clients.

“Michael’s appointment comes at a critical juncture in Lightship’s growth,” said David MacMurchy, CEO of Lightship. “His extensive experience working in both the CRO and site spaces, combined with his ability to solve complex client challenges, makes him the ideal leader to strengthen our market positioning. Michael’s strategic vision, proven ability to drive business growth, and commitment to patient-centered solutions will be instrumental in helping us expand our reach to more clients—and ultimately more patients—enhancing our impact across the industry.”

Shipton has held senior leadership positions at some of the most recognized names in the industry, including Profound Research, Science 37, Syneos Health, and Quintiles (now IQVIA), where he led significant go-to-market transformations, drove sales growth, and oversaw cross-functional teams to achieve commercial excellence. His proven track record and passion for improving health outcomes will be critical to driving Lightship’s mission forward with even greater impact.