CRO2019 — CRO/Sponsor Summit

Ensuring the quality of the clinical data generated for regulatory submissions is a major challenge today for both the Clinical Research Organizations (CROs) as well as the Sponsors Pharmaceutical Organizations. Where on one hand, computerization, automation, and LIMS have helped in data management, on the other hand, it has also made data alterations much easier. Therefore, for regulatory success both the CRO conducting the study and the Sponsors have to play a pivotal role in ensuring quality in clinical studies.

Topics: Formulation Development, Regulatory Affairs, Analytical/Bio-analytical Development, Quality Control, Quality Assurance, Investigator Site Management, Outsourcing Management, Auditors, Clinical Research and Development, Analytical Method Development, IT & Data management, Pharmacovigilance, Medical Affairs R&D and Strategic issues, Business Development, CRO/Sponsors