CASE STUDY

Board of Directors Requests Assistance

The Board of Directors of a Summit, NJ company with a lumbar and cervical disc replacement product were concerned about the lack of progress being made on the clinical trials for the products. The representatives on the board from the venture capitalist firm with a major position in the company requested that BBA conduct a site audit to determine if there were any issues with the trial. The audit findings showed that the trial was not on schedule and that deficiencies cited needed to be addressed for the trial to succeed.

The Board of Directors requested that BBA assume management of the trial to address the deficiencies identified in the audit. BBA helped the company modify its regulatory protocol, assumed responsibility for medical monitoring management, managed the subcontractor providing data management services, and provided due diligence services in preparation for the sale of the company. Under BBA, the study had 24 sites with 350 patients with a two year follow up. BBA restructured the trial, trained all of the sites on the revised protocol, managed the outside firm providing data management services and managed the clinical trial for approximately six months until the sale of the company.

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