SOUTHBOROUGH, MA – June 12, 2023 – 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.
Based in Fréjus, France with an office in Brighton, UK, Scinopsis brings synergistic competencies to Veristat’s existing medical writing team. Scinopsis writers are highly qualified scientists with most members of the team holding a Ph.D. or M.D degree. The team has extensive experience meeting the requirements of regulatory organizations in Europe and the United States, with mastery in reporting and filing documents including clinical trial and regulatory documents and medical communications, along with medical device plans, reports, publications, and patient-friendly communications. Many staff members have held previous roles in biopharmaceutical environments across clinical and pre-clinical research, medical writing, and project management.
Effective medical writing in the clinical and regulatory realm has always been important, yet with the increasing complexity of today’s diverse scientific solutions and novel therapeutics it is essential,” said Patrick Flanagan, Chief Executive Officer of Veristat. “Medical writing informs critical decisions being made during clinical research, regulatory approval, and post-marketing. Expanding our medical writing capabilities globally was a business imperative, and I am thrilled to have Scinopsis join with Veristat. Our strength continues to be the combined capabilities of our exceptional team.”
Medical writing for rare diseases, particularly in gene and cell therapies, holds additional challenges when compared to medical writing requirements for treatments that address larger patient populations. Less common statistical methods, data from smaller patient populations, natural history data, real-world evidence, and various other non-traditional data types are some of the unique circumstances medical writers confront as they strive for content clarity, accuracy, and effectiveness. Both Veristat and Scinopsis have significant expertise supporting the development of complex therapies for rare diseases and oncology.
Quality medical writing is unquestionably key to having productive engagement no matter the therapeutic category, audience, or document type,” stated Dr. Sarah Hopwood, Chief Operating Officer of Scinopsis. “We have built our reputation on an unwavering commitment to quality. I am proud to work with a leadership team and global organization that shares our values. With Veristat’s extensive experience in strategic consulting, regulatory affairs and publishing, global clinical operations, biostatistics and programming, the joining of our organizations offers clients access to additional services while delivering confidence that the writing quality and collaborative support they have come to expect from our team will continue.”
Dr. Barbara Balser, Veristat’s Co-founder and Chief Scientific Officer, remarked,
I am delighted to welcome the Scinopsis team to Veristat. The combination of the Scinopsis team with our experienced medical writing team will provide our clients with a global approach to the complexities of successful regulatory writing.”
More information on Veristat’s medical writing services can be found at https://www.veristat.com/services/regulatory-affairs/medical-writing
Veristat, a scientific-minded global clinical research organization (CRO) enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval and commercialization. With more than 29 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program.
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. Every day, we apply this knowledge base to solve any program’s clinical, regulatory, statistical, data, or operational 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 patients’ lives.
Since its inception in 2006, Scinopsis has served as a trusted partner to clients in the pharmaceutical, biotechnology, and medical device industries to navigate the regulatory landscape to expedite their time to market with high-quality medical writing services and support. Based in Fréjus, France with an office in Brighton, UK, Scinopsis is guided by an unwavering focus on quality, the highest levels of scientifically rigorous content, flexibility to meet stringent timelines, consistent communication, and proactive project management.
Lauren L. Brennan, Vice President of Marketing, Veristat