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

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.

Why Choice Matters for Participants

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.

Why Choice Matters for Sponsors and CROs

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.