Partnerships 2010: Growing Traditional Outsourcing Relationships Into Customized Multifaceted Alliances

Panelists:
Mark Harvill, President and Chief Operating Officer, PARAGON BIOMEDICAL
Thomas Engels, Vice President, Clinical Affairs, CARDIOKINETIX INC

This session continued the debate of the full service provider versus the functional service provider. The presentation was an example of how Paragon Biomedical and Cardiokinetix Inc. worked out their business relationship.

The decision process used by these individuals involved assessing the CROs culture/compatibility, the CRO capabilities and finally cost. Key to the selection of the vendor was the recognition that the vendor would be an extension of the sponsor so a “fit” was absolutely essential for the success of this interaction.

The sponsor used a number of metrics by which to assess the vendor. Therapeutic expertise/experience was critical as were the geographical locations the vendor was located in.

They felt that being flexible was a key consideration in selecting the right vendor due to the nature of conducting clinical trials and the many challenges that present themselves.

Some of the other metrics employed in the evaluation of the CRO was cost, CRO assessment of strength/weaknesses, CRO philosophy, governance, human connection, quality, escalation and innovation/evolution. A detailed discussion of each of these metrics was provided.

The presentation was summed up by stating that compatibility and communication were the keys to working together. Emphasis was placed on the social component between the groups that led to the vendor being selected. Constant communication and necessary training was provided on an as needed basis. A shared vision between the groups was also emphasized as being a key factor to success.