Post-approval studies are different.
WE'LL HELP YOU FOCUS ON WHAT'S IMPORTANT.
At Bioclinica, we understand the fundamental differences between the design and conduct of post-approval studies and those performed prior to approval.
Building on our leadership team's broad experience, we took a close look at the post-approval landscape—and found a way to improve on it, especially as it relates to comprehensive and cost effective late phase research for observational studies and large, simple Phase 4 trials.
We're able to do this thanks to a unique combination of substantial global trial experience and domain knowledge; strategic, operational and regulatory expertise in post-approval studies; and a robust and fully-integrated technology infrastructure specifically designed for this type of research.
THE RESULT? WITH OUR UNIQUE APPROACH, YOU CAN COMPLETE POST-APPROVAL STUDIES MORE EFFICIENTLY AND MORE COST-EFFECTIVELY.
We offer full-service capabilities to meet your study needs, from developing protocols to executing all operational aspects through final regulatory submissions.
In doing so, we take a consultative approach and act as an extension of your team—partnering to establish key objectives and uncover ways to maximize efficiencies and enhance value.
Key benefits for pharmaceutical, biotech and medical device companies:
- Proven methodology and validated processes specifically designed for post-approval studies
- Consultations and customized study design to optimize outcomes
- Dedicated groups focused on site support and patient retention
- Fully integrated and flexible technologies created especially for post-approval studies
- Access to unique datasets and analytics
- Program design and protocol development
Bioclinica's expertise in designing and executing post-approval research is the outgrowth of real-world experience and understanding the limitations of traditional methods and approaches. Our team is recognized around the globe as experts in the field of post-approval research.
Specifically built and fine-tuned for the demands of post-approval research, our advances in technology-driven program execution reduces overall resource requirements—which translates into a 15-20% cost savings on post-approval programs.
- Flexible, scalable and customizable
- Transparency for all stakeholders
- Full access to real-time study metrics
- Third Party/Vendor interface and integration
Program Coordinating Center (PCC)
Our dedicated staff has expertise in executing site management strategies tailored to meet the needs of all physicians, from seasoned clinical research sites to traditional doctors' offices. Robust methods and practices are supported and documented by validated SOPs developed expressly for post-approval studies.
Patient Outreach Center (POC)
Carefully designed patient outreach processes and technology increase patient compliance and data collection by 25-30% compared to conventional PRO technologies.
Bioclinica's Post-Approval Research division is focused and dedicated exclusively on post-approval research. Our expertise in designing and executing post-approval research for observational studies and large, simple trials provides a comprehensive, full-service, turnkey and cost-effective solution for pharmaceutical, biotech and medical device companies.