Decentralized Clinical Trial for Medical Device

This global device CRO first connected with Remington-Davis (RDI) when they were brought in to manage a complex stem cell device trial mid-project. After inheriting RDI as a clinical trial site, the CRO saw firsthand how dedicated RDI was to delivering a patient-centric experience and high-quality data. This led them to consider RDI for other studies when the opportunities presented themselves.

The CRO soon won a study contract with a leading provider of migraine glasses for light management. They brought RDI in as one of two sites on this rapid enrollment device study.

“We knew we wanted to get them involved in as many studies as we could,” the CRO’s former president Brandy Chittester said.

With the device trial set to start amid the global pandemic, it became apparent the initial trial design would need to be adjusted to accommodate pandemic-related restrictions and safety protocols. RDI’s flexible, service-oriented approach made it easy for the team to shift. RDI management suggested a decentralized clinical trial (DCT) model to the sponsor and CRO. This allowed for adherence to both protocol requirements and existing study timelines.

Leading MedTech Service Provider

Brandy Chittester

Senior Director, Clinical Operations

The Clinical Trial Focus

Migraine prevention glasses

How RDI Offered Support

Leveraged flexible approach moving to a decentralized clinical trial design at the start of COVID
Enabled rapid enrollment with patient database and efficient turnaround times

The Challenge:
Pivoting To a Decentralized Clinical Trial

The hypothesis behind the migraine glasses was that migraines could be prevented by blocking specific wavelengths of light. Operating under this assumption, the glasses would prevent the wearer from needing other medications or therapies to alleviate migraine symptoms.

Following the results of an initial trial to validate the hypothesis, the study sponsor determined that more patients were needed. The second trial, which RDI conducted, included 60 patients. To showcase effectiveness, the trial included randomization, with glasses that blocked specific light wavelengths and tinted placebo glasses that did not.

When the COVID-19 pandemic hit, operations for the majority of clinical trials came to a screeching halt. The RDI team saw this challenge as an opportunity to get creative. On the one hand, the CRO’s team couldn’t travel due to restrictions, and at the same time patients couldn’t come to RDI for their visits due to COVID-19 health and safety guidelines.

With the study sponsor under pressure to meet FDA-mandated trial deadlines and bring their product to market, RDI approached the CRO and sponsor with the idea to conduct the trial remotely — and both agreed with this approach. The CRO shipped the glasses to RDI, who hand delivered the study device directly to patients. RDI employed telemedicine in combination with front-door service, sending masked SCs to the subjects’ doorstep for delivery and return of study documents such as paper diaries. This allowed patients to share their data remotely and have visits conducted without coming on site. RDI maintained the data so the CRO could support and monitor the trial remotely and be assured that all protocol requirements are met.

“For us, the highlight was that we were able to keep going,” Chittester noted. “With RDI’s support, we were able to run a fully remote study before it was common and get the trial done on time.”

Early work with remote clinical trials positioned RDI as a leader in DCTs. RDI has leveraged this experience to enable a smoother execution of remote clinical trials.

Rapid Enrollment Helps Keep Trial Timelines on Track

RDI’s flexibility allowed for a seamless transition to a remote setup and the rapid enrollment of study volunteers kept the trial moving.

“RDI has a really good network of patients,” Chittester highlighted. “They already knew who was potentially eligible for a migraine study and who to reach out to.”

The timely execution of contracts and IRB submission also supported an on-track pace. RDI can get contracts signed in less than two days and IRB approval in less than three days.

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While Remington-Davis proved to be a valuable site partner in this decentralized trial, RDI also supports on-site trials at their facility in Columbus, Ohio. The 5,000 square-foot facility features modern comforts and amenities that cater to the needs of study participants and sponsors alike. And with expertise that extends across more than 20 therapeutic areas, RDI has the resources and experience to seamlessly manage a wide variety of trials.

These factors paired with Chittester’s positive experience have made RDI an invaluable partner to have in her network. With plans for expansion at her current company, Chittester looks forward to new opportunities to partner with RDI in the future.

“Where I am now, I’m thinking, what can we take to Remington-Davis?” Chittester said. “I'm ready to call them as soon as the right kind of project comes through.”

Remington-Davis Keeps Device Trial on Track by Pivoting to a Decentralized Design