Your drug has been approved for the marketplace, but your work isn't finished. Post-approval studies need to be carried out to obtain real-world data, assess your product's safety profile, and support your product's lifecycle. Such studies require an innovative mindset, a specialized infrastructure, unique processes, customized technology, and targeted expertise. Bioclinica's Post-Approval Research division delivers all that and more.
Customized Post-Approval Research Strategies
Bioclinica's Post-Approval Research division is comprised of a dedicated team with experience in designing and executing post-approval research for observational studies, post-marketing commitments, post-approval safety studies, and large, simple trials. Our full-service solution includes comprehensive post-approval services, from program design and protocol development to regulatory submissions.
Our experienced Post-Approval Research team develops and implements customized strategies for each drug, specifically structured for the needs of post-approval research. Our tactical approaches are streamlined and patient-centric, drawing on real-time data collection and analysis.
The Bioclinica Difference
With a dedicated Post-Approval Research division, you benefit from:
- SOPs specifically developed for post-approval research
- Enhanced patient engagement, compliance, and retention
- An increase in data collection by 25-30% by proven methodologies
- Insightful study design that anticipates physician and patient needs
- Superior data access and analysis for deep insights
- Greater efficiency, resulting in cost savings of 15-20%
- Solutions that maximize your return on investment
- An expert staff 100% focused on post-approval research
- Consultations and customized study design to optimize outcomes
- Proven post-approval methodology and validated processes
- Fully-integrated and flexible technologies created for post-approval studies