Mark Staples has managed project teams and technical groups for over 25 years, most recently as VP R&D. He has directed multi-organization and international teams to successfully complete CMC sections for regulatory submissions (US and Europe).

Dr. Staples is available, via CUSP, to assist client management in several capacities-

  1. Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs): screening, auditing, selection and management of CROs and CMOs that complement the resources of the client organization

  2. Project Team management: performing project management and/or team leadership duties associated with CMC-related tasks

  3. Functional group (line) management: available to assist with a range of supervisory and management duties tailored to client needs. May include training inexperienced staff, creating work plans, coordinating internal schedules, and drafting group budgets and projected resource needs.

  4. Risk mitigation: provide assessment of project risks and the tactics and strategies that may reduce overall project risk.