International medical device and biotech consulting firm MEDIcept chooses BSI CTMS for its CRO services

On the lookout for a combined CTMS (Clinical Trial Management System) and eTMF tool at the end of 2022, MEDIcept reached out to global eClinical solutions provider BSI Life Sciences for a demo. “From the very beginning, we knew BSI Life Sciences’ software was the right choice for us. Also, we were informed that the next product version was just about to be released, and that we would be onboarded on it,” says Managing Director and VP of Clinical Services at MEDIcept Dr. Adelina Paunescu. BSI Life Sciences CTMS with integrated eTMF has high configuration capabilities and provides a granular access control system, which is critical for managing large virtual teams of diverse roles. “With presence across the United States and the UK, plus a significant portion of our workforce operating remotely, it was imperative for MEDIcept to find a collaborative tool which would allow us to conduct clinical trials efficiently and effectively, streamlining communication and avoiding duplicate work,” continues Dr. Paunescu. As BSI Life Sciences’ Project Manager Cecilia Ferrari explains, the software “includes an alert notification system and several pre-configured workflows to simplify team collaboration when managing studies, whereas a conflict prevention functionality detects data entry incidents before they happen.”

Being an international consulting company, MEDIcept also deals with the challenges faced by its life science clients both in North America and overseas to comply with regional regulatory requirements: “Knowing BSI CTMS is ICH-GCP, EU Annex 11 and [21 CFR] Part 11 compliant gives us the “peace of mind” to be able to focus on work that matters and provide the best possible services to our customers,” remarks Dr. Paunescu.

MEDIcept went live with BSI Life Sciences CTMS V7.0 in June 2023, after a remote training session to accommodate the different time zones of its team members. The software adoption by the US company has been hailed as another success for BSI Life Sciences. In the words of Community Manager Life Sciences Jan Nielsen, “MEDIcept’s investment in BSI Life Sciences’ eClinical platform is an important step in our efforts to grow our market presence in North America. We are thankful to Dr. Paunescu and her team for trusting BSI Life Sciences’ products and are confident they’ll be fantastic ambassadors for our digital solutions. We look forward to our continued collaboration and future achievements.”

About MEDIcept

MEDIcept is a global medical device, IVD, combination product, and biotechnology CRO and regulatory compliance consulting firm. For over three decades, they have assisted thousands of companies from across the globe with expert, tailored services in Clinical Services, such as Operations, Data Management, Vendor Selection, as well as Regulatory Affairs, Quality Management Systems, Quality Engineering, Software Engineering, Training, and Inspections, among others. MEDIcept’s core values are Integrity and Effective Communication to provide clients with innovative and quality solutions. The company is headquartered in Ashland, MA, and has offices across the US and the UK. Its team has been involved with more than 50 trials, over 600 regulatory submissions and almost 20,000 patient subjects.

For more information, please visit: www.medicept.com

About BSI Life Sciences

BSI Life Sciences offers smart eClinical software for CTMS, eTMF and more. BSI makes life science software for people – and has done so for 25+ years. BSI’s software solutions made in Switzerland, Germany, USA, and anywhere else clients need them to be, are innovative and user-friendly. They focus resources on staying ahead of the trends and delivering functional, compliant, and affordable eClinical software. In this way, BSI helps its customers continuously optimize and accelerate the clinical development process. And that’s what they love!

For more information, please visit: www.bsi-lifesciences.com