Business Wire

Veristat Expands Pharmacovigilance and Safety Services with Acquisition of Certus PV

Share

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.”

“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.

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 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.

Contact information

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

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Luxembourg to Start Real Life Testing of an International Standard for a Digital Circularity Fingerprint for Products27.11.2020 14:00:00 EETPress release

The Ministry of the Economy of Luxembourg just launched phase two of the development of an international standard. It provides information on the circularity of products to all stakeholders involved along their value chains. A first viable version of the standard is being tested in real life, allowing to identify the most suitable governance model, the audit scheme and reliable IT systems for its management. Luxembourg started the Circularity Dataset Initiative in 2018 to address the difficulty for industry and consumers to access reliable data on the circular properties of a product. A lot of circularity information is missing, as its generation and handling requires too many human and financial resources. Furthermore, trade secrets are hindering transparency and reporting standards are lacking, forcing manufacturers to send out different data sets in diverse formats to customers and product platforms. To tackle these challenges, the Luxembourg government is working with multinational

Chengdu Continues to Enhance Trade Links and Cultural Exchanges to Expand Circle of Friends Around the World27.11.2020 12:24:00 EETPress release

The Chengdu-Europe railway line spans over 10,000 kilometers across countless rivers and mountains, transporting goods to vast numbers of people across the Eurasian landmass. With increased trade, cultural links between Chengdu and Europe are also growing stronger. Against this backdrop, Chengdu-Eurasia National Pavilion Cluster (CENPC) has emerged in the Qingbaijiang District of Chengdu to further promote trade and cultural exchanges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005270/en/ Head of CENPC’s pavilion for France and the Netherlands Xu Dandan at work (Photo: Business Wire) CENPC is an important platform for trade exhibition and cultural exchange between countries along the Belt and Road. With trade promotion as a foundation, the project, which is expected to feature over 40 national pavilions, aims to deepen Sichuan’s global cooperation in fields such as culture, talent, education, and science and techno

Chengdu-Europe Railway Adds Momentum to Chengdu's Rise as an International Hub, Leading to Closer Cooperation Between Chengdu and Tilburg27.11.2020 12:14:00 EETPress release

Chengdu in China's Sichuan Province and Tilburg in The Netherlands, the two cities at the opposite ends of the Eurasian landmass, are now closely connected via an intercontinental railway that spans nearly 11,000 kilometers. In a recent interview with Xinhuanet, Roland Verbraak, general manager of GVT Group of Logistics - the Dutch partner of the Chengdu-Europe Railway, praised: "Not only are our relationships with Chinese partners getting closer, but the two cities of Chengdu and Tilburg have also become sister cities. Chengdu's international development is progressing well at a rapid pace." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005267/en/ Roland Verbraak, general manager of GVT Group of Logistics (Photo: Business Wire) Goods shuttling along the Chengdu-Europe Railway line have not only spurred economic growth in China and The Netherlands but also deepened links between Chengdu and places along the route, add

REPLY: Reply enters into eSports27.11.2020 11:00:00 EETPress release

Reply, on the eve of Milan Games Week, announces its entry into eSports in collaboration with Totem eSports, a project born in 2019 that spent the year battling its way through the most competitive titles of the main ESL circuits, which for the 2021 season will be renamed Reply Totem eSports. The Reply Totem eSports team, thanks to the experience gained by its young talents at national and international level, will compete in the next season in the ESL EVC circuits on the mobile titles including Clash Royale, Brawl Stars and on a series of other titles, ranging from sports such as FIFA to FPS and strategic cards. Reply's entry into eSports is part of a wider range of initiatives aimed at supporting young technology enthusiasts. With this collaboration, Reply, which already operates in the gaming sector with Game Studio and B2B initiatives, enters a market in continuous growth, that symbolizes the impact of digitalization in all sectors. Filippo Rizzante, Reply's CTO, commented: "The eS

Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years27.11.2020 11:00:00 EETPress release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for SYMKEVI® (tezacaftor/ivacaftor) with KALYDECO® (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. “With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF,” said Reshma Kewalramani, M.D., Chief Executive O

Thales to Deliver the World’s First Fully Integrated Unmanned Mine Countermeasures System for the Royal Navy and French “Marine Nationale”26.11.2020 22:55:00 EETPress release

Following the first phase of the program in which two demonstrators have successfully proven their operational performances at sea, France and the United Kingdom marked the tenth anniversary of the Lancaster House treaties by signing a joint contract for Thales to start the production phase of MMCM to deliver eight unmanned mine hunting systems (four for France and four for the United Kingdom). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005783/en/ MMCM system at sea ©Thales With the threat of mines and improvised explosive devices present in all conflicts involving naval forces, countries need to strengthen the protection of their maritime domain, to ensure the protection of their assets and to safeguard the freedom of civil navigation. At the same time, it is essential to limit human exposure to mines. With 50 years of expertise serving navies around the world, Thales develops technologies that enable the transiti

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom