Articles from Veristat

Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced expanded regulatory and clinical trial services to international pharmaceutical and medical device companies seeking a streamlined path into European, including the United Kingdom and Switzerland, plus Australian, Canadian, and U.S. markets. Particularly, Veristat has helped many Chinese companies – including Hansoh Pharma and CStone Pharmaceuticals – successfully navigate regional regulatory requirements and legal complexities leading to product approvals. Now, Veristat is expanding to provide comprehensive regional clinical trial support.

Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that Kim McLean Boericke has been named Chief Executive Officer (CEO). Boericke, an experienced executive with decades of leadership and operational experience in the clinical research industry, succeeds Patrick Flanagan. After 13 years as CEO of Veristat, Flanagan will transition to Veristat’s Board of Directors.

Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced today that it will participate in the Clinical Outsourcing Group – Bay Area 2025 conference, taking place October 21-22, 2025 at the Hyatt Regency San Francisco Airport, Burlingame, CA. Veristat is speaking with AOBiome Therapeutics, a clinical-stage biotech company focusing on inflammatory conditions, on October 21 at 4:45 p.m. PT and will address how early integration and honest, sometimes difficult conversations between sponsors and CROs can improve trial success.

Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announces its successful partnership with Cook MyoSite to support the DigniFI Study, a two-stage, randomized, controlled Phase III trial comparing the safety and efficacy of iltamiocel with placebo in the treatment of female participants with chronic fecal incontinence (FI) and a history of obstetric anal sphincter injury (OASI). Veristat successfully supported Cook MyoSite in onboarding 26 sites and enrolling more than 100 participants with >95% study adherence to meet a critical milestone for the study.

Veristat, a leading global clinical research organization (CRO) and consultancy, proudly congratulates George Medicines on the U.S. Food and Drug Administration (FDA) approval of WIDAPLIK™ (telmisartan, amlodipine and indapamide), a novel single pill combination treatment for hypertension in adults, including as initial treatment, to lower blood pressure.

Veristat, the Science-First Full Service CRO and Consultancy, is pleased to announce that Gabriela Rosu, M.D., has joined as Senior Director, Global Medical Affairs.

Veristat, the Science-First Full Service CRO and Consultancy, announced an appointment to its executive leadership team. Rachel Page joins Veristat as Chief Commercial Officer (CCO), succeeding Veristat’s longtime leader Cindy Henderson, who recently transitioned to become Chief Strategy Officer (CSO) to focus on developing and executing Veristat’s customer-driven corporate strategy.

Veristat, the Science-First Full Service CRO and Consultancy, announced it has joined the Alliance for Regenerative Medicine (ARM), the leading international advocacy organization championing the benefits of cell and gene therapies for patients, healthcare systems, and society. The announcement falls the week before members of Veristat’s Executive team are attending ARM’s Cell & Gene Meeting on the Med (#MeetingOnTheMed) being held in Rome, Italy.

Veristat, a scientific full-service clinical research organization (CRO) and consultancy, has acquired Instat Clinical Research, an expert biometrics CRO with a 20-year track record of transforming complex data into precise study results.

Veristat, a scientific-minded global clinical research organization (CRO), has acquired Scinopsis, a European medical writing consultancy with a 17-year track record of delivering regulatory and medical communication documents of the highest quality to the biopharmaceutical industry. The acquisition strengthens Veristat’s ability to meet growing client demand in one of its highest-valued service areas as the range of clinical trial content expands and the importance of regulatory documentation increases.

Veristat, a scientific-minded global clinical research organization (CRO) and regulatory consultancy, shared today the addition of three seasoned leaders to Veristat’s Executive team. The appointments reflect Veristat’s rapid rate of global growth, supporting sponsors in overcoming the challenges of operating in complex and highly regulated clinical environments.

Veristat, a scientific-minded, global clinical research organization (CRO), today congratulated HIPRA for marketing authorization by the European Medicines Agency (EMA) and European Commission of BIMERVAX®, a bivalent adjuvanted vaccine based on the Beta and Alpha variants of SARS-CoV-2 and indicated as a booster dose for people over 16 years of age. BIMERVAX® is the first bivalent recombinant protein vaccine against the virus to be authorized in the European Union and the first human health vaccine to be designed and developed in Spain.

Veristat, a scientific-minded global clinical research organization (CRO), announced today that the Company supported clients in preparing marketing applications for eight therapies that received regulatory approval in 2022. The approvals from the US Food and Drug Administration (FDA) included one Biologics License Application (BLA), five New Drug Applications (NDAs), and one Supplemental New Drug Application (sNDA). One Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) was approved, and collectively most of the approvals were for therapies targeting a rare disease. Veristat’s success in preparing marketing applications that receive approval can be attributed to the ability of our integrated teams to navigate the complex regulatory submission process with the FDA and regulators around the world.

Offering integrated solutions for the implementation of decentralized clinical trials (DCTs), Veristat presented the advantages of its flexible and fully customized service delivery model at the Decentralized Trials Research Alliance (DTRA) annual meeting, which took place last month in Boston. DTRA is an association of leading organizations whose members join together at its annual event to share ideas, develop lasting connections, and create new bonds over a shared mission to make patient-focused research accessible to everyone.

Veristat announced that it has joined an alliance of over 120 life sciences and healthcare organizations whose mission is to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The Decentralized Trials & Research Alliance (DTRA) unites industry stakeholders which include healthcare companies, regulators, patient groups, clinical research and development organizations. The Alliance is dedicated to making clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research.

Veristat, global experts in clinical development, registration and post-marketing solutions proudly announces its recognition once again by Inc. Magazine as one of the 5000 fastest-growing private companies in the United States.

Veristat, a scientific-minded global clinical research organization (CRO), announced that Cindy Henderson has been promoted to Chief Commercial Officer (CCO) from Executive Vice President, Strategic Development. As CCO, Cindy will continue to oversee all commercial functions including strategy, proposals and contracts, business development, commercial operations and marketing, in addition to driving business expansion and executing on growth opportunities.

Veristat, a scientific-minded global clinical research organization (CRO), announced the appointment of Joe Scott to the position of Chief Financial Officer. Joe brings 20+ years of operational finance, corporate IT and CRO experience to the role, building and leading global teams, driving growth organically as well as through acquisitions, and leveraging business partnerships to facilitate transformative change. He joins Veristat from CRO Advanced Group where he served as Chief Financial Officer focused on establishing the financial infrastructure, spearheading the implementation of a streamlined global standardized operating model, and driving top line growth. Prior to that, Joe was at Parexel where he held positions of increasing scope and responsibility, most recently serving as Senior Vice President, Strategic Finance. Joe led the organization through significant expansion, managing a substantial global budget, enhancing internal controls and overseeing the global talent upgrade of the Finance department which resulted in an efficient team aligned with metrics-driven performance.

Veristat, a scientific-minded global clinical research organization (CRO), announced today that the Company supported clients in preparing marketing applications for 12% of the 2021 U.S. Food and Drug Administration (FDA) novel drug approvals. This surpasses the number of approvals supported in 2020. In 2021, the FDA approved 50 novel drugs, defined as New Molecular Entities (NMEs).

Veristat, a scientific-minded global clinical research organization (CRO), announced today the expansion of its regulatory services capabilities by acquiring Drug Development and Regulation (DDR), a scientific and regulatory consultancy with offices in Barcelona and Amsterdam. This well-timed acquisition advances Veristat’s regulatory capacities in Europe and the United Kingdom (UK) as it works to accelerate the development of novel therapies for a growing number of biotech, pharmaceutical and medical device clients.

Veristat, a scientific-minded global clinical research organization (CRO), announced the appointment of Colleen Pelton to the role of Chief Talent Officer. Ms. Pelton joins Veristat following an impressive record of success in executive HR roles, most recently at Dental Services Group, St. Jude Medical, and Smith & Nephew during which time her responsibilities included the integration of acquired businesses and accelerating growth globally.

Veristat, a scientific-minded, global clinical research organization (CRO), announced today that it transferred its majority ownership from Variance Development Partners to WindRose Health Investors (WindRose). WindRose invests exclusively in healthcare companies and has extensive experience across the healthcare services landscape, including outsourced biopharmaceutical services like Veristat’s.