Outsourcing Training


WIN Outsourcing Consult offers customised outsourcing training to Client's study team members and stakeholders 

The key delivery of the study team is to successfully ensure timely and cost-effective study conduct with high quality data output upon completion.

Small/mid-size Sponsors often rely heavily on outsourcing the clinical study conduct to CROs and Vendors. Many small/mid-size Sponsors do not have a dedicated CRO/Vendor Management*) resource in-house, so many of the outsourcing disciplines are often assumed part of the role of the Sponsor’s study team members. However, while such study teams are usually highly skilled and clinically or medically specialised within their field, they often lack competencies related to e.g. managing the contract and the relationship, overseeing CROs deliveries or resolving poor performance by the CROs/Vendors.

Customised training will be based on the priciples of:

  • Best practice outsourcing processes
  • Understanding the contract, work order and the dynamics within them
  • Overseeing CRO/Vendor performance and deliveries and proactively identify issues, which can result in quality issues, delay or budget overruns
  • Ensuring good governance structures with CROs/Vendors
  • Building trust and win-win solutions between CRO/vendors and Pharma/Biotech
  • Best-fit payment schedules
  • Contracting Models
  • Negotiation techniques

    *) The term “CRO/Vendor Management” includes a multitude of disciplines and includes e.g. researching and sourcing in CROs/Vendors, obtaining proposals and analysing quotes, assessing capabilities, turnaround times and quality of work, negotiating contracts, managing/governing relationships, assigning responsibilities, managing and evaluating CRO performance, and ensuring payments are made in accordance with the contract.

    CRO/Vendor Management requires a lot of skills, resources and time and the individual disciplines are usually split by a group of people each having a specific role – e.g. study team, outsourcing expert, legal advisor, financial controller etc.