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Deal provides Synchrogenix withproprietary technology, expert staff, and new capabilities to become the dominant player in life science regulatory and medical writing
Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry. Their combined team will now include more than 200 regulatory and medical writers with expertise in document development for the U.S. Food and Drug Administration, European Medicines Agency (EMA), and other global regulatory organizations.
“Large pharma and biotech companies are increasingly looking to outsource their regulatory and medical writing requirements,” said Certara Chief Executive Officer (CEO) Edmundo Muniz, M.D., Ph.D. “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.“
“By bolstering its investment in regulatory and medical writing, Certara is increasing its commitment to drug development stakeholders and helping them to meet the growing need for expert medical information and documentation assistance across the clinical development and commercialization processes,” said Dr. Muniz.
“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.
“ClinGenuity also brings a flexible operational model and expanded commercial capabilities to our clients, allowing us to offer the best solution to meet their needs and those of the dynamic pharma industry as a whole. Furthermore, Keith Kleeman, founder and CEO of ClinGenuity, and his team possess outstanding expertise, credibility in the industry, and strategic vision that make them the ideal addition to the Synchrogenix, Certara family,” said Ms. Kendle.
New European and U.S. clinical trial data transparency initiatives – such as EMA Policy 70, which goes into effect in January 2015 – are creating additional disclosure compliance requirements for pharma and biotech companies. For example, they will now 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 Mr. Kleeman, who will become president of Synchrogenix.
ClinGenuity offers a broad range of medical writing services, including the development of clinical study reports, protocols and submissions, medical letters, and commercial documents such as peer-reviewed articles. It also has transparency/disclosure products, which include redaction, lay summary, and data mining services.