Synchrogenix, the regulatory and medical consultancy of Certara, a Princeton, N.J.-based global biosimulation technology-enabled drug development and drug safety consulting company, has acquired ClinGenuity, a Cincinnati-based artificial intelligence-assisted medical writing service. Their combined team now will include more than 200 regulatory and medical writers with experience in document development for the FDA, EMA and other global regulatory organizations.
“Large pharma and biotech companies increasingly are looking to outsource their regulatory and medical writing requirements,” said Edmundo Muniz, M.D., Ph.D., Certara CEO. “With the addition of ClinGenuity’s technology-enabled solution and experienced medical writers to our Synchrogenix team, we will be able to enhance process efficiencies and increase the offerings we can deliver to our clients.”
“With the addition of ClinGenuity’s automated redaction management capability to our existing transparency services, which include registration, disclosure documentation and clinical lay summary development, we can enable our clients to meet global transparency requirements efficiently,” said Synchrogenix CEO Kelley Kendle.
New European and U.S. clinical trial data transparency initiatives—such as EMA Policy 70, which went into effect in January 2015—are creating additional disclosure compliance requirements for pharma and biotech companies. For example, they now will need to redact and de-identify datasets in their clinical study reports and submission documents, produce research summaries suitable for a lay audience and publish their clinical study information publicly.
“We are excited to be joining Synchrogenix at this important stage in the industry’s growth; it will enable us to expand the depth and breadth of services that we can offer to our clients as they seek to meet these new regulatory requirements,” said Kleeman, who will become president of Synchrogenix.
ClinGenuity offers a range of medical writing services including development of clinical study reports, protocols and submissions, medical letters and commercial documents such as peer-reviewed articles. It also has transparency/disclosure products including redaction, lay summary and data mining services.
