Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

Doctors and Scientists

CRO/CMO Project Management

Management of contract research organizations and contract manufacturers ensures a coordinated work flow from drug discovery through preclinical research to the clinical trials stage. They require active management to keep them on track and on budget.

The Project Managers at PharmaDirections have the skills and experience for dealing with CROs and CMOs. Most of our project managers have come from CROs where they were responsible for preclinical research or manufacturing. PharmaDirections has positioned itself through its infrastructure and choce of skilled project managers to provide the epitome of project management skills and services for its clients. When we manage CROs or CMO, we include the following activities as part of our services:

  • Identify appropriate vendor(s)
  • Select vendor in coordination with client
  • Negotiate the price and payment schedule
  • Negotiate timing with vendors
  • Recommend to client how to handle vendor qualification
  • Finalize study protocols with selected vendor
  • Interface with selected vendors during conduct of studies (status, troubleshooting, etc), data analysis, and finalization of reports
  • Continually update client with status, issues and proposed modifications to plan

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