Incorporating patient voices into clinical trial summaries

Companies are now required to develop plain language summaries (PLS) for the results of all clinical trials with participants in the European Union. The biopharmaceutical industry is facing two main challenges to meet this new requirement: attaining PLS authoring expertise and engaging patients, caregivers, patient advocates, and clinicians during the development of PLS.

Having authored more than 200 plain language summaries to date, Certara Synchrogenix medical writers have the expertise needed to deliver efficiently and effectively.

We’ve developed a secure, user-friendly electronic portal called PODIUM, which enables patients to review and make suggestions for improvement of the plain language summary from their perspective. PODIUM also provides the ability to evaluate reviewers’ understanding of PLS content.

“Patients want to learn everything they can about their health. Unfortunately, much of the available literature is so complex that it is not usable for patients. Synchrogenix is working with Rare Patient Voice patients to incorporate their voices into clinical trial summaries. This is a wonderful way to ensure that important scientific data is available to patients in a clear and understandable format.”

– Pam Cusick, Vice President, Business Development | Rare Patient Voice

Patient-centric solutions

Customizable PLS template

Certara Synchrogenix’s customizable template provides readers with a visually appealing, easy to understand plain language summary. The template is customizable to a sponsor’s corporate style guide, preferred word use, and graphics and encourages greater efficiency in the drafting, review, and finalization process.

Patient engagement via PODIUM

Using our secure PODIUM platform, sponsors can receive valuable responses throughout the clinical trial process from patient groups within specified therapeutic areas. Gain valuable insights to inform protocol feasibility and feedback on documents intended for patient use.