Theorem Clinical Research, a King of Prussia, Penn.-based full-service CRO that provides core clinical R&D services, also helps clients identify and strategically address early and ongoing device-related regulatory and clinical issues.

Theorem develops clinical study protocol and design for pre-Investigational Device Exemption (pre-IDE) activities, IDE submissions and IRB review and approval. The goals of these services are both to optimize medical clients' pathway to marketability and to ensure their high-quality adherence to all post-marketing requirements, said Evan L. Rosenfeld, vice president of medical and scientific affairs, medical devices and diagnostics, Theorem.

“The traditional CRO doesn’t offer a full spectrum of regulatory services,” Rosenfeld said. “At Theorem, we go above and beyond to help our clients focus on the regulatory processes in addition to tactical protocol development and then running their clinical trials.”

Theorem offers a strategic clinical and regulatory approach to pave the best pathway for such efforts, from original trial design to study start, through FDA and IRB review and approval, and ultimately to market entry.

With the FDA’s greater emphasis on post-marketing surveillance and trials, Theorem also provides additional trial setup for its clients and saves time in those respects.

“We help our clients meet both the FDA’s requirements for post-marketing surveillance and also the evidentiary requirements that insurance companies may impose for product reimbursement,” Rosenfeld said.

Theorem’s process for pre-IDE services includes a thorough review of the relevant regulatory provisions and guidance documents, analysis of relevant research in the field, review of the past outcomes for similar devices and a determination of the studies that may be required for both regulatory market entry and subsequent insurance coverage.