Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 2020

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Our project teams excel at navigating complex clinical development nuances and exploring the appropriate regulatory pathways to quickly get therapies to patients. We understand that the stakes are high when preparing a marketing application, so we have assembled a cross-functional team of statistical, medical writing, and regulatory experts adept at navigating the process of preparing, publishing, and defending marketing applications.

“What differentiates Veristat is our ability to both conceptualize and operationalize the entire pathway of development from initial evaluations of effectiveness and safety through to the primary clinical trial basis for regulatory action. We accomplish this through diligent application of scientific principles and close collaboration with our clients,” said John Balser, Ph.D., President & Chief Statistical Officer at Veristat. “In 2021, Veristat will continue to strengthen our scientific expertise, integrated team approach, and regulatory capacity around the globe so we can meet the demands of our sponsors.”

About Veristat

Veristat, a global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years’ experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last ten years.

Veristat’s focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. We apply this knowledge base every day to solve any clinical program’s challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives. For more information, visit www.veristat.com.


ihttps://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020

View source version on businesswire.com:https://www.businesswire.com/news/home/20210114005878/en/

Contacts

Veristat Contact:
Gillian Dellacioppa, Marketing Director
gillian.dellacioppa@veristat.com or +1 508-306-6336

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