Case Study #3

Biotechnology Company With Limited Budget Uses Virtual CROs To Work With Experienced Providers

A sponsor was having difficulty managing its investigator-initiated research (IIR) program with a lengthy review and approval process, and performing IIR studies in compliance with regulatory and industry guidelines. The sponsor purchased Sharepoint as an internal tool for document tracking and sharing, but it went unused due to lack of training. Field-based medical science liaisons had difficulty accessing timely information to provide oversight of the programs and ensure integrity.

The FSMO engaged the sponsor to provide a map of the existing workflow of the company at the time of engagement. Several bottlenecks were identified as delays in the review and approval process and the coordination with field-based medical liaisons.These delays led to physicians losing interest in initiating the studies.

The FSMO selected a lead project manager who was responsible for identifying the existing workflow and challenged areas. The team also engaged an expert to review and evaluate regulatory guidelines, comparing the existing workflow and activity of internal team members with those required by the industry.

Interviews with various key team members were held to determine activity levels and existing work practices. The FSMO suggested a newer workflow and SOPs that conformed to regulatory requirements. Based on the suggested workflow and the sponsor’s desire to maintain a lean organization, the FSMO engaged a Sharepoint partner to identify a strategy for managing the workflow through technology.

The sponsor initiated and leveraged all SOPs and adjusted workflow per the plan as Phase I and cited many workflow benefits as a result. The workflow allowed the team to increase performance by processing additional study programs for review without adding to the head count. It also allowed the team to use Sharepoint in a limited way. One trained internal resource could track and manage the programs and provide support for the field-based medical science liaisons.

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