BioClinica, a specialty clinical trials services and technology provider, has launched its newest service line offering. The Post-Approval Research division of its Global Clinical Research business segment was created to meet the rapidly growing and ever-evolving needs of the post-approval research industry.
BioClinica's expertise in designing and executing post-approval research for large, simple trials; complex post-approval safety studies; and patient-centric post-marketing studies provides a comprehensive, full-service, turnkey and cost-effective solution for pharmaceutical, biotech and medical device companies.
Leveraging its technology expertise, Bioclinica has built a post-approval study-specific technology platform which streamlines the overall study resource requirements. In addition, it offers full access to real-time study metrics and transparency for all stakeholders. Like all BioClinicatechnology, the Post-Approval Research platform is flexible, scalable and customizable.
BioClinica’s Post-Approval Research operates a Program Coordinating Center (PCC) with dedicated and experienced post-approval research staff. The PCC provides global operational infrastructure from centralized locations to support local languages and time differences. In addition, a unique service offering of the Post-Approval Research division is the development of the Patient Outreach Center (POC). BioClinica's POC has carefully designed processes and technology which increases patient compliance and data collection by 25-30%, compared to traditional methodologies and Patient-Reported Outcomes technologies.
"At BioClinica, we understand the fundamental differences between the design and conduct of post-approval studies and those performed prior to approval. We believe the substantial and deep domain knowledge of our management team, coupled with our state-of the-art-technology, allows us to achieve our strategic goals in post-approval research,” said Dr. John Hubbard, president and CEO, BioClinica.
Nayan Nanavati, COO, BioClinicaPost-Approval Research, adds, “Our full-service capabilities are designed to meet all post-approval 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. With our unique approach, we can complete post-approval studies more efficiently, with fewer resources, and most importantly, more cost-effectively.”