The companies say their collaboration will provide “unique, value-added capabilities to biopharmaceutical companies” by seeking to streamline each stage of the process from drug candidate development to clinical evaluation.
“The Fulcrum Pharma collaboration is an atractive and exciting proposition for Ricerca and our clients,” said Ian Lennox, CEO of Ricerca, “Fulcrum Pharma brings deep experience in investigational new drug (IND) authorship and regulatory approval, which fits well with Ricerca's pre-clinical services in discovery pharmacology, chemical development and drug safety assessment.
“The relationship greatly expands our ability to serve our clients who are preparing for regulatory submission anywhere in the world.”
Fulcrum Pharma is an Aptiv Solutions company - a conglomerate comprised of six companies providing global biopharmaceutical and medical device development services. The group formed in February this year after six companies: Averion International, Trio Clinical Research, ClinResearch, Niphix, ADDPLAN and fulcrum Pharma, merged.
Patrick K. Donnelly, Aptiv Solutions' chairman and CEO, and one of the founders of PRA International, said: “The collaboration offers our early stage clients a streamlined service to move efficiently through preclinical development to creation of high-quality IND submissions.
“This approach, coupled with our expertise in adaptive clinical trial design, will provide our clients with the ability to accelerate the development of their products and stay ahead of the competition.”
As a result of the merger, Aptiv claims to offer industry leading software combined with executional expertise in adaptive clinical trials “the advanced capabilities and process knowledge of drug and medical device development experts, and the flexibility of a global Clinical Research Organization.”
According to Donnelly, “the difficulties facing companies developing products in life sciences have intensified. Companies that continue to rely on conventional techniques risk missing out on new, rewarding opportunities that accelerate their alternatives.”