PRINCETON, NJ - Apr 23, 2015 - Certara®, the 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, today 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. 

Synchrogenix CEO Kelley Kendle said, “Biopharmaceutical companies want to address proactively the growing demand for transparency and clinical data disclosure to the patient community. Synchrogenix is excited to be able to offer this collaborative solution with CISCRP that meets regulatory expectations, should help to enhance sponsor relationships with the patient community, and increase transparency around clinical trial results.”

“Access to clinical trial data is a key step toward building trust between the biopharm industry and the public, while greatly expanding the opportunity for increased scientific research,” said Ken Getz, CISCRP founder and board chair. “We are delighted to be working with Synchrogenix to develop these lay summaries of clinical trials that will help to keep the patient community engaged and increase patients’ understanding of the crucial role that they play in the development of new therapies.”

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. Working together, the two organizations have developed a consistent, sustainable delivery model that will help to ensure that all the stakeholders in a clinical trial are fully informed.

This new program combines Synchrogenix’s commitment to high-quality regulatory writing with CISCRP’s dedication to engaging patients and the public as partners in the clinical research process. 

About CISCRP
CISCRP is a nonprofit organization that is dedicated to providing, educating, and informing the public, patients, medical/research communities, media, and policy makers about clinical research and the role each party plays in the process. For more information, visit https://www.ciscrp.org.

About Synchrogenix, a Certara™ Company
Synchrogenix, a Certara™ company, encompasses a group of separate entities operating together to provide regulatory writing services to the pharmaceutical, biotech, and medical device industries worldwide. Synchrogenix Information Strategies Inc.; Synchrogenix Europe, Ltd.; and Synchrogenix Philippines, Inc. (SPI) are all wholly owned subsidiaries with an overall governance structure that creates and enforces a global standard of service, technology, and quality.

About Certara
Certara is a global biosimulation technology-enabled drug development consultancy. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit www.certara.com.