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Kirsten Colling

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Kirsten Colling
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 on cancer immune therapies and autoimmune diseases.

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Post-approval research studies are vastly different from pre-market studies designed for the registration of a new drug or device. In the white paper "One Size Doesn’t Fit All": Applying an Innovative Mindset to Post-Approval Research, I outline these differences and illustrate why companies ought to leverage strategies, processes, standard operating procedures (SOPs), and technologies that are specifically designed for and more relevant to post-approval research.

Over the last decade, across the globe, the regulatory landscape has changed considerably, with greater focus and awareness on pharmaceutical products post-approval. Legislation, coupled with public concerns about the safety of marketed drugs and the need to evaluate safety and effectiveness of the marketed products in a real-world setting is forcing many companies to embark on post-approval research.

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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