Clinical Forum for Operational Excellence

Outsourcing is a fact in clinical development. There are now more employees in Clinical Research Organizations (CROs) than in pharmaceutical or Biotech companies. The shift from ‘doing’ to ‘outsourcing, managing and overseeing’ falls to the pharma and biotech companies. The CROs are responsible for the majority of the operational delivery. On top of this we see an increase in the complexity of technology and services available to deliver clinical trials from more conventional EDC, CTMS, IXRS through eCOA, risk based monitoring, Study start up specialists, spirometry, ECGs, and functional outsourcing e.g. Pharmacovigilance or Clinical Data Management. More Pharma or Biotech companies are having full service CROs subcontract on their behalf to the ancillary vendors. What does this third party outsourcing mean for CROS and for oversight by pharma/Biotech’s?