Synchrogenix Acquires ClinGenuity
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.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
