Meeting Development Challenges With the Virtual Clinical Organization
Contributed by Nancy Fuller
A virtual clinical organization (VCO) links biotech and pharmaceutical sponsors more closely with partners to create breakthrough products quickly and cost effectively.
Clinical trial sponsors have realized that clinical development partners can provide global reach, a flexible resource pool and the technology needed to run large global trials and manage a widely diversified product portfolio.
A virtual clinical organization (VCO) is a network of clinical partners who are committed to a common set of strategic and operational objectives and supported by integrated business processes and technologies. They are the latest step in an ongoing evolution in the relationships among sponsors and service providers.
Until recently, partners were selected on a trial-by-trial basis with each study team choosing its vendors through RFPs. This resulting in a significant vendor management challenge and delayed start-up. In an effort to control quality, many sponsors forced vendors to utilize standard operating procedures and technologies, which resulted in longer training times, less flexibility to adopt new processes and technologies and increased risk.
In recent years, pressure to improve quality while reducing cost and delays led many large pharmaceutical companies to establish preferred vendor relationships and exclusive partnerships. This improved pricing and sped start-ups, and allowed many sponsors to improve their vendor management capabilities and hold partners accountable for specific operational measures.
Figure 1: Evolution of clinical Development Partnerships
Virtual Clinical Organization
The VCO removes many of the downsides of traditional partnerships, such as misaligned goals, lack of shared investment and competing priorities. However, integrating a partner into a VCO requires:
Integrated strategic planning:
Sponsors must include partners in their strategic planning to ensure they think strategically about how to meet the sponsor's most pressing challenges. The VCO should set realistic annual performance improvement objectives and commit resources to ensuring they are met. Each partner should have a financial commitment so that all members succeed or fail together.
Effective governance with aligned metrics and rewards:
Senior leaders from both organizations should be part of a governance structure to ensure strategic goals are achieved and investments continuously monitored. The governance body should review operational performance against agreed upon goals and ensure performance keeps improving, identifying the process and technology improvements that could have the greatest impact. Pricing should be directly linked to outcomes, and both partners held accountable to a clear set of shared metrics.
Integrated clinical trial processes and technology
Sponsors must work with their partners to develop integrated business processes that optimize the process, rather than the needs of either party. Responsibilities should be divided to drive operational efficiencies and improvements in timelines, as well dramatic cost reductions, without sacrificing quality. Integrated processes must be supported by integrated technologies that provide near real time data exchange and insights. An integrated information architecture helps the sponsor monitor the partner's performance, build trust and reduce the need for process redundancy.
Figure 2: Changing Vendor Selection Criteria
A VCO at Work
A top-10 pharmaceutical organization that had partnerships with separate data and site management vendors, as well as three therapeutic centers of excellence, asked for our help reducing site start-up times by 50%. We found the main causes of delay included training the site monitor, completing and tracking site training, getting the drug to the site and scheduling the site initiation visit.
We worked with the client and its partners to change roles and responsibilities, improve communication and make training completion reports available to site personnel. Discussions between the sponsor and the vendors led to an agreement on operational and strategic metrics. We then worked with both parties to identify the data needed in the clinical data repository to support the integrated business processes and performance metrics. We also helped the client build a portal that allows all partners to communicate and track progress. As a result, the client reduced average site start-up time from four months to six weeks.
VCOs require a new level of cooperation, investment and shared risk among the sponsor and its partners to completely align strategic and operational objectives. Sponsors must facilitate process and technology change among partners to assure optimal performance. Vendors must balance standardization in their own organizations (for economies of scale) with providing partners with customized solutions that meet their needs. Sponsors must also evaluate potential partners based on how well-aligned their business strategy is with the sponsor's strategic objectives.
For more information, read the white paper Meeting Development Challenges With the Virtual Clinical Organization (PDF) and about our services in the Pharmaceutical and biotech industries.