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Certaa announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity.
Certara®, a global biosimulation technology-enabled drug development and drug safety consulting company, announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity, an artificial intelligence-assisted medical writing service for the pharmaceutical industry. Their combined team now includes 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. This move, in part, addresses the new European and U.S. clinical trial data transparency initiatives – such as EMA Policy 70, which goes into effect this month– 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.
Read the full release here.