Delivering on Customer Demand for Pharmacovigilance from Clinical Trial Conduct to Post-Marketing Support
SOUTHBOROUGH, Mass.–(BUSINESS WIRE)–#clinicalresearch—Veristat, a scientific-minded global clinical research organization (CRO), announced today the expansion of its safety and pharmacovigilance offering by acquiring Certus PV Services Inc. Certus PV, a Canada-based company, offers pre-approval and post-marketing pharmacovigilance, and safety monitoring support for drug developers working to get their therapies approved and kept on the market.
“We understand how important it is for sponsors to demonstrate patient safety surveillance beyond marketing approval,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “The addition of Certus PV allows Veristat to offer clients the continuation of high-quality pharmacovigilance from an accomplished team of experts beyond the conduct of a clinical program.”
Certus PV supports a range of clients and has a reputation for delivering quality safety services at the regulatory submission stage. As a sponsor prepares its Marketing Application, Certus PV will develop and negotiate the Risk Management Plans with the regulatory agencies and set-up the PV systems and associated procedures. Once approval is obtained, all other PV and medical information activities are initiated. The entire Certus PV team will continue to operate under its founders, Rita Cassola and Agnes Jankowicz.
Rita is a registered pharmacist with over 20 years of global and Canadian pharmacovigilance experience in the pharmaceutical industry. Agnes brings nearly 20 years of experience in global and Canadian pharmacovigilance, medical information, and regulatory affairs within the pharmaceutical industry. Both are recognized pharmacovigilance leaders and educators, regularly presenting at industry conferences, webinars, and training courses. In addition, Rita and Agnes bring a qualified team of PV experts each who average more than 7 years of PV experience to Veristat.
“Certus PV and Veristat share the same team values, culture, and dedication to patient safety,” said Rita Cassola, Vice President of Pharmacovigilance at Certus PV, a Veristat Company. “I anticipate a seamless integration of our high-quality expertise as sponsors navigate the marketing application planning process and post-marketing safety surveillance. (Read more…)”
“Together with Veristat,” stated Agnes Jankowicz, Vice President of Pharmacovigilance at Certus PV, a Veristat Company, “we are committed to ensuring the safety of our clients’ therapies throughout the entire clinical development and regulatory approval process and throughout its life on the market.”
The addition of Certus PV to Veristat supports Veristat’s focus on meeting client demands and offering quality services across the entire drug development journey. While Veristat is known for its dedication to patient safety throughout clinical trial planning, execution, and the approval process, the company is expanding that safety expertise into post-marketing.
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 nearly 100 marketing applications for approval with global regulatory authorities in the last 10 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.
Gillian Dellacioppa, Marketing Director
[email protected] or +1 508-306-6336