Outsourcing is a strategic decision that can add to the available expertise, strengthen flexibility, and serve to maintain a lean organisation.
Marketing Authorisation Holder/Sponsor remains overall responsible, whether GxP regulated activities are done in-house or outsourced! CRO/vendor must be audited and outsourcing of GxP activities must be properly planned and managed in order to maintain Sponsor oversight, control over critical activities, and ensure that a clear quality structure continues to safeguard the patients and provide a flexible support to business activities.
As a competent dialog consulting partner Drug Safety Consult can offer support to outsourcing of GxP regulated activities via audit and consultancy during the planning and maintenance phases.
Contact here.