Synchrogenix, CISCRP Partner on Lay Summaries of Clinical Trials
Certara®, a global biosimulation technology-enabled drug development consultancy, and CISCRP, an independent nonprofit organization dedicated to educating and informing the public and patients about clinical research, announced that they are partnering to produce high-quality lay summaries of clinical trials.
Certara®, a global biosimulation technology-enabled drug development consultancy, and CISCRP, an independent nonprofit organization dedicated to educating and informing the public and patients about clinical research, announced that they are partnering to produce high-quality lay summaries of clinical trials. Lay summaries are brief descriptions of a clinical trial’s design, objectives and results, and are written for biopharmaceutical companies to share with the general public.
The recently published Institute of Medicine report, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk,” outlined principles and shared a framework for the responsible sharing of clinical trial data. The tenets outlined in this report, along with EFPIA and PhRMA’s responsible data sharing principles and the new European Medicines Agency Clinical Trial Regulation have resulted in increased focus on clinical trials disclosure. Leading biopharmaceutical companies are now creating Scientific Review Boards to independently assess requests for clinical data and implementing broader clinical trials transparency programs with an emphasis on communications to both the research and lay communities.
Synchrogenix’s medical writers will develop the text and images for each lay summary and implement the company’s quality control processes to ensure data and message accuracy. CISCRP will deliver a critical, unbiased review of the report, engage and interact with investigative sites, and manage production, dissemination and communications of the report.
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