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Recording, analyzing and reporting
NEWTOWN, Pa. & MIAMI—A “combination of factors” prompted BioClinica Inc., a specialty clinical trials services and technology provider, to acquire Synowledge, which specializes in pharmacovigilance, regulatory affairs and information technology services to support biopharmaceutical companies with recording, analyzing and reporting adverse drug events, according to BioClinica CEO Dr. John Hubbard.
In general, the acquisition—financial details of which were not disclosed—is expected to help BioClinica to expand its position in the drug safety and regulatory business process outsourcing market.
But more specifically?
“A key factor in the acquisition was the opportunity to extend BioClinica’s offerings with the complementary regulatory affairs and safety capabilities of Synowledge,” Hubbard explains. “With the acquisition, BioClinica now offers the leading pharmacovigilance platform in the industry. Together we offer extensive capabilities and an impressive track record in supporting drug development.”
He adds, “The ability to enhance our delivery of around-the-clock service to the global pharma community was especially attractive. Synowledge brings dual delivery centers 100 miles apart in Bangalore and Mysore, India, as well as offices in the U.S., Ireland, Germany and Japan. This increases our existing footprint, which includes five U.S. locations, and locations in France, Germany, England, China and Japan.”
BioClinica, which delivers expertise and technologies designed to enhance clinical research data and analytics worldwide, offers medical imaging services, enterprise eClinical technologies, clinical research centers and cardiovascular safety solutions for every phase of clinical development. BioClinica’s experience spans three decades and includes thousands of studies in various therapeutic areas.
Founded in 2006, Synowledge assists and enables small, medium and large life-sciences organizations in satisfying their global regulatory requirements. The Synowledge team helps companies to meet and exceed the challenging demands of the R&D life cycle. The company’s outsourcing solutions cover numerous therapeutic areas.
Sankesh Abbhi, founder of Synowledge and now BioClinica’s new vice president and head of global safety and regulatory solutions, says, “We saw becoming a part of BioClinica as equally attractive from our vantage point. This gives us an exciting opportunity to become part of a unique organization that shares a common goal: improving clinical research. This also provides us with a larger infrastructure to support and expand our offerings, while broadening our global reach and customer relationships.”
Asked how Synowledge will be integrated into BioClinica and what the expected benefits for customers are, Hubbard replies, “Safety and Regulatory Solutions is now a division of BioClinica’s eHealth business segment. Because we came in with a solid integration process right up front, this has been a seamless transition. Everyone has been conducting business as usual, keeping focused on customer service and delivery.”
Hubbard says that adding these adjacent services within BioClinica’s eHealth business segment “is a perfect fit not only for BioClinica and Synowledge, but also for sponsors who need high-skill regulatory and safety services.” He believes that the industry “has shown a lot of interest and support since the announcement,” adding “From the customer perspective, this opens a new world of possibilities.”
Abbhi explains that “Combining our deep knowledge of the complex regulatory process and our experience with processing over 300,000 adverse events annually, with BioClinica’s technology services on thousands of trials, creates a unique and valuable offering not seen before in the global pharmaceutical, biotechnology and medical device community. As a specialized pharmacovigilance, regulatory affairs and IT services provider, we are able to assist life-sciences companies in satisfying their global regulatory requirements, whether they are small or the industry’s largest organizations. Our expert team understands the regulatory challenges within every aspect of the R&D life cycle.”
The two companies have several shared customers, including Daiichi-Sankyo, Roche, Baxter, Jazz, Biogen Idec, Merck Serono, Endo and Teva. Abbhi says that he looks forward “to the unique synergies our combined organization brings to the table.”
He concludes, “Pharmacovigilance, regulatory affairs and IT services represent a $15-billion combined market that is expected to grow at double-digit rates over the next several years. Key factors driving growth within our regulatory affairs business include an industry trend toward outsourcing for cost efficiencies, a shortage of skilled employees and an increasingly complex, global regulatory environment.”