The Pharmaceutical, Biotech and Medico corporations fights on becoming the first to reap the benefits of their R&D work, through key success factors such as patent rights, test group strategies, time-to-market and mass production.
Besides the market and competitor parameters are a number of regulatory requirements, where lack of complience can be the end of a pharma or biotech company.
In Peak we advise clients on how to optimize and streamline project execution, recognizing and respecting the given regulatory requirements, such as FDA, GxP, GAMP.
Peak has expertise within the area of Clinical Data Management, including EDC strategies, development of validation plans, implementation of clinical data management systems (URS, IQ, OQ, PQ etc.) and management of the outsourcing process of clinical data management and studies.