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Synchrogenix teams up with CISCRP to improve global medical writing capabilities

Synchrogenix, the regulatory writing unit of US-based pharmaceutical firm Certara, has formed a partnership with Center for Information and Study of Clinical Research Participation (CISCRP) to offer clinical trial results to the volunteers in lay language.

The alliance is expected to boost the global medical writing capabilities of Synchrogenix. CISCRP has been working on this initiative for four years.

The initiative will enable the companies to provide high-quality, written summaries of the trial results to the participants on behalf of the pharmaceutical, biotechnology and medical device manufacturers.

Precised summaries in plain-language accounts will uphold the design, objectives, and findings of the trials and will be in line with Pharmaceutical Research and Manufacturers Association (PhRMA) and European Federation of Pharmaceutical Industries Association (EFPIA) transparency commitments and pending European Union requirements for layperson summaries.

Synchrogenix president and CEO Kelley Kendle said: "With increasing and impending regulation, sponsors are feeling the pressure to proactively address the demands of disclosure to the community.

"This new partnership combines Synchrogenix’s technology-enabled operational expertise and clinical writing talents with CISCRP’s unbiased governance and dedication to engaging patients and the public in the spirit originally intended of the clinical research process."

CISCRP Patient Communication and Engagement Programs director Zach Hallinan said: "More than two dozen industry sponsors have begun implementing lay-language communication programs with CISCRP.

"By partnering with Synchrogenix, a market leading global provider of medical and regulatory writing services, we can dramatically expand our ability to meet sponsor requests while ensuring non-promotional and scientifically accurate communication through CISCRP’s proven process and independent, neutral nonprofit status."

While the medical writers Synchrogenix will present each of the lay summaries in text and images, CISCRP will conduct a critical review of it without bias.

The former will utilise its artificial intelligence technology platform, and implement the necessary quality control processes for optimum data and message accuracy.

CISCRP will also interact with investigative sites and manage production, dissemination and communications of the report.

The collaborative efforts will ensure the framing of a stable delivery model which can, in its turn, help in maintaining transparency by keeping the trial participants informed.