Medical Device Link.

Originally Published MX September/October 2004

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

With the burgeoning complexity of regulatory and clinical data requirements for combination products involving drugs and devices, full-service clinical research organizations (CROs) are being called upon to play an increasingly active role in product development programs.

CRO regulatory personnel are typically involved in many product development programs, and are therefore broadly familiar with global regulations as well as unwritten expectations. More importantly, these regulatory specialists have often observed firsthand which strategies have been successful and which have failed, making them well qualified to guide device and drug development teams to the best choices for their programs.

While many device trials are small and can be conducted with resources internal to the device development company, trials for combination device-drug products are frequently expected to be much larger in scope. Such trials are beyond the internal resources of a typical device company. CROs can fill this resource gap efficiently and, if the developer's regulatory advice and clinical resources come from the same CRO, the transition into clinical trials can be quick and seamless.

When a combination product developer begins working with a CRO, the business relationship is likely be a fee-for-service consulting agreement, in which the developing company pays an hourly fee for advice or guidance from a regulatory specialist. As the program moves into clinical trials, companies can expect a modified fixed-fee arrangement, in which the CRO consents to conduct a trial according to agreed specifications for a fixed fee. Although some firms have experimented with risk-sharing arrangements, they have generally been unfavorable for one or both parties.

Copyright ©2004 MX