De-Risking Clinical Trials with an Expanded Access Site Model

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.

Why a single model increases risk

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.

The Three-Model Toolkit

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.

A disciplined approach to adoption

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.

Patient impact: choice reduces barriers

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 bottom line: choice is the safer bet

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. 

How Lightship can help

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.