Ashland, MA: MEDIcept Inc., an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), announces the acquisition of ACMP, a US-based privately held Clinical Research Organization (CRO) that provides full services for early phase, pre-, and post-market studies to the healthcare industry.
The combination of ACMP and MEDIcept provides medical device and IVD manufacturers with industry leading support. From product concept and engineering, through clinical and regulatory needs, to the post-market launch and post-market surveillance requirements, the increased services will provide product lifecycle compliance.
Both MEDIcept and ACMP have a common goal to positively impact medical device manufacturers with value-added services as they introduce new products to the market or adapt existing products to new regulatory environments and into new markets in a compliant, safe, and efficient manner. As previous collaborators, the transition is expected to be very simple for all ACMP customers.
Dr. Adelina Paunescu will serve as the MEDIcept Vice President of Clinical Affairs. Jerika Acosta will join MEDIcept in the role of Director of Clinical Affairs/Operations.
MEDIcept now offers 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 as vendor management, study payment, invoice tracking, and clinical audits.
Dr. Adelina Paunescu, Owner of ACMP, said: “We are very excited about this opportunity to provide our customers with full-service capabilities. Joining MEDIcept will enrich our relationships and offers to our clients. Together we hope for a long, expanded, fruitful future to bringing successfully and efficiently new products to market through the entire product life cycle.”
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 and now can supply full service clinical trial support. Because of the broad experience and capabilities in ACMP and our superior quality management compliance and infrastructure, the MEDIcept CRO services will help our clients meet all regulatory and clinical needs and still minimize inefficiencies and reduce unnecessary costs. Unlike working with big CROs, MEDIcept can provide specialized, tailored attention to all clients. As an extension of our client’s team, MEDIcept becomes a single point of contact to manage the project schedule, budget and supervise the project team. Together, we will be responsible for the success of the project and the relationship with the sites.”
MEDIcept Inc. is an international consulting firm specializing in medical device, IVD, and biotechnology Regulatory, Quality, and Clinical Services. Since 1996, we have worked with thousands of companies to solve their most critical FDA and ISO issues. Our integrated solutions are rooted in our direct experience and span all stages of the product life.
MEDIcept is committed to providing our clients with what they need. We are committed to quality deliverables because we value our clients’ time and resources. This is why 90% of our clients come back to us repeatedly to solve new issues.
For additional information, please contact Dr. Paunescu at apaunescu@MEDIcept.com or visit our website at www.medicept.com.