Conducting Post-Approval Research Requires a Unique Mindset and Specialized Infrastructure. Do You Have What it Takes?

Clinical Trials, Life Sciences, Medical Device, Medical Device Clinical Trials, Pharmaceutical Regulation,
  • Thursday, July 14, 2016

While post-approval research is evolving rapidly, and these studies are becoming far more complex, our knowledge in implementing and conducting such studies has not evolved with the same pace. There are fundamental differences in conducting research in pre-market randomized controlled trials (RCT) versus post-approval research. These differences are not only in the study intent and objectives but the operations and conduct. Applying appropriate regulatory regulations for post-approval research is an art not a science. Often we see the same regulatory rigor applied to post-approval research as RCTs which leads to inappropriate design and execution. Consequently, these studies become cost prohibitive.

Post-approval research studies are often massive and global with tens of thousands of patients and thousands of physicians. Managing such studies requires uniquely different operational infrastructure as well as processes. SOPs must be specially designed to support such studies and the operational mindset must be geared towards how to effectively manage research naïve physicians and implement patient centric approaches. Utilizing smart technology in not only desirable but necessary to contain study costs. By deploying such technology you will minimize resource burn and decrease costs.

Lastly, not all post-approval research studies are the same. Each study must be reviewed to ensure the correct strategies are applied for the various types of post-approval research.


Kirsten Colling, Senior Director Global Operations, Bioclinica Post-Approval Research

Kirsten has 20 years of Pharmaceutical industry knowledge spanning pre-clinical to post-approval research. She has worked at contract research organizations as well as a Top 10 Pharmaceutical company. Kirsten devoted the last 10 years to developing and managing teams on how to effectively operationalize post-approval research. She assists clients with the development and execution of insightful strategies to successfully implement and complete post-approval research, ranging from registries and post-marketing commitments to large global studies. Kirsten has also authored and co-authored articles in peer-reviewed journals.

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Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with financial lifecycle, safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.

Bioclinica’s Post-Approval Research division, a niche specialty clinical service provider, is dedicated exclusively to post-approval research. Our focus is in designing and conducting post-approval research for observational studies, post-marketing commitments, and large, simple trials. We also provide unparalleled expertise in post-approval safety studies. We offer comprehensive, innovative, technology-driven, cost-effective solutions with full-service capabilities for Pharmaceutical, biotech, and medical device companies.

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