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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.

Blogs

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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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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Our clients have substantial success w #eSource, some spanning well over a decade. Still other organizations remain… https://t.co/UwVs6ajPp4
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ICYMI: Our V.P./Head of Neuroscience & Cardiovascular Svcs., Dr. Joyce Suhy, talks about challenges in determining… https://t.co/Lns6B3VPPN
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RT @FCR_News_Today: FDA Issues New Guides on Use of Electronic Health Information in #ClinicalTrials. #ClinicalResearch https://t.co/j8LHV2…
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Latest Blogs:

Latin America: Benefit from the Right Partner
Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen