November 14, 2019, Ashland, MA – MEDIcept Inc., a leading international Quality and Regulatory consulting firm focused on medical device and invitro diagnostics, and ACMP Consulting, Acton, MA have entered into an agreement to provide Clinical Research Organization (CRO) services for early phase, pre-, and post-market studies to the healthcare industry.
The MEDIcept/ACMP agreement will offer medical device companies full clinical operations support, including:
- protocol development,
- site start-up activities,
- IRB communication,
- trial monitoring,
- data management,
- data and safety monitoring and Committees (CEC and DSMB),
- medical writing, and
- other consulting services such vendor management and clinical audits.
MEDIcept President, David Rothkopf, said: “MEDIcept plays an important role in the medical device and biotech industry as a champion of quality and regulatory practices. The new relationship expands and strengthens our services to our customer base to develop products and services that will protect and improve human health while minimizing inefficiencies to save time and reduce unnecessary costs. With the addition of CRO service we can better develop efficient and effective strategies for the submission and approval of devices.”
Dr. Adelina Paunescu, Principal of ACMP said: “The complementary synergies between our companies will increase service offerings. ACMP will be able to leverage MEDIcept’ s global relationships to expand our contract research capabilities and better serve our clients with design and execution of clinical trials. With this collaboration, MEDIcept and ACMP can serve our clients with full scope, from development, clinical trial data and regulatory authorities’ submissions to a successful clearance and approval.”