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Henk Johan Streefkerk

Contributor Biopharma Insights

Physician Scientist with more than 15 years of experience in Academia and Healthcare industry. Started in Early Clinical Development as a Clinical Pharmacologist. Held different global medical roles in Translational Medicine (TM) and Patient Safety (PS). Expert TM and PS member of submission teams, resulting in worldwide approvals (Rasitrio™, Entresto™, and Kisqali™). Clinical development and outsourcing experience across indications including Oncology, Cardio-Metabolic, Critical-, and Primary Care. Extensive experience with GCP inspections and resulting CAPA implementation and execution. Currently working at PIQUR as the Chief Medical Officer.

 

CROs Pharma R&D Outsourcing

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Choosing The Right CRO For Pharma R&D Outsourcing

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Choosing The Right CRO For Pharma R&D Outsourcing

This post was originally published on Quora, answering the question: "How do drug manufacturers select the right contract research organization(CRO)?"

Selecting the right contract research organization (CRO ) obviously depends on what activity is outsourced and with which regulations the outsourced processes need to comply. However, the following criteria certainly apply to pharma companies.

Typically, we would request evidence on how often the CRO has performed the activity, i.e., what their relevant experience is from a technical operation point of view. However, it is also very important to understand how they deal with Quality Assurance, Training, Disasters, and if they have been inspected by health authorities before, if upon inspection there were any critical findings, and how they managed these findings.