What Does It Take to be a BPO Provider in the Pharmaceutical , Biotechnology, and Medical Device Industries?

A true BPO organization in the Pharmaceutical, Biotechnology, and Medical Device Industries provides expertise in clinical trial research. Expertise is defined as the ability to run clinical trials independently or in an integrated manner with a Sponsor company. Therefore, the BPO provider must have the following capabilities:

• Strategic staffing AND true clinical management oversight with internal infrastructure support and expertise
• Expertise in process improvement through organizational collaborations that ultimately enhance the overall study deliverables
• Scalability not only in terms of geographic reach (national and international), but also of cross-functionality (project management, investigational site recruitment, site management, clinical monitoring, data management, safety surveillance, statistics, programming, medical writing, and regulatory affairs)
• TOTAL flexibility through infrastructure support including:
  • Ability to conduct full-service work with transfer of obligations
  • Ability to develop an ideal workflow through the use of either the Sponsor’s SOPs/operating system, the provider’s, or a combination of both
  • Ability to allow the utilization of not only provider’s facilities but also supportive management for integration (IT, QA, and
    support structures)

A true BPO provider is one that can operate with a common platform, systems, standard operating procedures, and workflow to obtain and maintain a seamless and efficient interconnection.