By Ben Adams
Princeton, NJ-based BioClinica is looking to take big steps into the growing realm of helping biopharma with data and costs after launch as it unveils a new division focused on postapproval studies.
The CRO has created the Post-Approval Research division--part of its Global Clinical Research business--in order to "meet the rapidly growing and ever-evolving needs of the postapproval research industry," according to a statement.
The new division will see BioClinica offer its services for a range of postapproval studies, including complex safety studies and patient-centric postmarketing studies.
To do this, the CRO has built a postapproval study-specific technology platform that offers access to real-time study metrics.
Nayan Nanavati, COO of Bioclinica Post-Approval Research, explained: "Our full-service capabilities are designed to meet all postapproval study needs, from protocol development to operations through regulatory submissions. In doing so, we take a consultative approach, acting as an extension of our clients. We partner with them to establish key objectives and uncover ways to maximize efficiencies and enhance value.
"We're able to do this thanks to a unique combination of extensive global trial experience and industry knowledge; strategic, operational and regulatory expertise in post-approval studies; and a robust and fully-integrated technology infrastructure specifically designed for post-approval research."
This comes a week after the company announced a new tie-up with Japanese CRO EPS to focus on risk-based monitoring in clinical trials, one of 6 new deals the company has made in the past 18 months alone.
A number of CROs are looking to expand into postapproval service offerings; just last week CRO giant Parexel ($PRXL) inked a new pact with Optum Life Sciences to help lower costs in postapproval studies.
- read the statement