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Medical Affairs is responsible for developing and implementing medical tactics and strategies for promoting a brand or therapeutic area. Personnel in the medical affairs department work in close association with sales/ marketing and healthcare professionals with a key function to promote brands/products specific scientific and medical information for an organization.

Medical Affairs has originally emerged as a reaction because of increasing pressure from regulators to separate medical and commercial functions. Companies have been experiencing increasing internal demand to focus on generation and development of new products rather than managing products after FDA approval.

In present state of affairs, clinical research is considered as one of the promising domains for any health care organization. Clinical research studies leads to the generation of data whose management is not an easy task to perform by any biopharmaceutical organization. Clinical Data Management System (CDM) is leading clinical development industry into a new innings of transformation.

Medical Affairs team works closely with the clinical development team for planning and organizing clinical development plan, protocol development, investigator selection and meetings, ongoing data maintenance and management, statistical analysis & interpretation, report writing activities etc. They are involved in pharmacovigilance, regulatory support, post marketing safety and surveillance studies.