In early 2022 Mannheim-based CRO Advanced Medical Services (AMS) found itself at a crossroads after receiving news that the eTMF (electronic Trial Master File) solution they had been using for years to manage clients’ clinical studies would be discontinued. AMS was carefully evaluating the eClinical systems market to find a new solution that could replace their end-of-life eTMF and a way to safely migrate their existing regulatory documents. The challenge soon turned into an opportunity:
Why not taking advantage of the situation to upgrade from just an eTMF to a fully comprehensive Clinical Trial Management System (CTMS), which also provided extensive monitoring and tracking capabilities of study and site statuses? After some research, AMS learned about Swiss-based IT company BSI Life Sciences and its eClinical tool, BSI CTMS with an integrated eTMF. “When we saw the first demo, we were immediately captivated by the comprehensiveness of the software,” recalls AMS Director of Clinical Operations, Harald Wagner. “We realized we could have a single platform in the cloud to manage all aspects of our clients’ clinical trials,” continues Wagner. Fast forward a couple of months, and BSI was training the first CTMS key users at AMS’ headquarters in Southern Germany. The software go-live took place right before winter break in December. “I’m amazed at how fast things went”, comments Shanti Amann, eTMF System Matter Expert at AMS; “BSI helped us customize the software, so that for instance we could keep the same TMF structure we had been using for years. This means adapting our standard operating procedures for the new digital tool took very little time and effort. And the eClinical solution came fully validated.”
For BSI Life Sciences Community Manager, Jan Nielsen, the successful onboarding of AMS consolidates BSI’s presence in the DACH region with its software solutions for clinical trials. “We are proud to serve well-established and internationally renowned companies like AMS.
We know that the adoption of BSI CTMS will make a difference, both for AMS and for its clients, who are mainly clinical trial sponsors in the pharma industry and the academy,” says Nielsen. The Community Manager also emphasizes BSI’s peculiar customer-centric approach, which ensured a short roll-out time for AMS: “In agreement with Mr. Wagner and his team, the entire onboarding including the software training sessions was conducted in German. Also, the end of Covid measures meant it was possible for us to visit our client onsite, like we used to do with all customers pre-pandemic,” he added.
Thanks to the BSI CTMS subscription model, AMS will benefit from free annual product upgrades and a bilingual support in English and German.
About Advanced Medical Services
Founded in 1997, Advanced Medical Services (AMS) is an experienced CRO providing a full range of services to clinical trial sponsors, including Project Management, Monitoring, Quality Management, Biostatistics and Data Management, Pharmacovigilance and Medical Writing. AMS has been a European leader in the fields of Market Access, Health Technology Assessments (HTAs) and Rapid Relative Effectiveness Assessments (rapid REAs), and a pioneer in the benefit assessment of medicinal products in Germany. Its customers include world-leading pharmaceuticals, medical devices and biotech companies.
For more information, please visit: www.ams-europe.com
About BSI Life Sciences
BSI 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
Why not taking advantage of the situation to upgrade from just an eTMF to a fully comprehensive Clinical Trial Management System (CTMS), which also provided extensive monitoring and tracking capabilities of study and site statuses? After some research, AMS learned about Swiss-based IT company BSI Life Sciences and its eClinical tool, BSI CTMS with an integrated eTMF. “When we saw the first demo, we were immediately captivated by the comprehensiveness of the software,” recalls AMS Director of Clinical Operations, Harald Wagner. “We realized we could have a single platform in the cloud to manage all aspects of our clients’ clinical trials,” continues Wagner. Fast forward a couple of months, and BSI was training the first CTMS key users at AMS’ headquarters in Southern Germany. The software go-live took place right before winter break in December. “I’m amazed at how fast things went”, comments Shanti Amann, eTMF System Matter Expert at AMS; “BSI helped us customize the software, so that for instance we could keep the same TMF structure we had been using for years. This means adapting our standard operating procedures for the new digital tool took very little time and effort. And the eClinical solution came fully validated.”
For BSI Life Sciences Community Manager, Jan Nielsen, the successful onboarding of AMS consolidates BSI’s presence in the DACH region with its software solutions for clinical trials. “We are proud to serve well-established and internationally renowned companies like AMS.
We know that the adoption of BSI CTMS will make a difference, both for AMS and for its clients, who are mainly clinical trial sponsors in the pharma industry and the academy,” says Nielsen. The Community Manager also emphasizes BSI’s peculiar customer-centric approach, which ensured a short roll-out time for AMS: “In agreement with Mr. Wagner and his team, the entire onboarding including the software training sessions was conducted in German. Also, the end of Covid measures meant it was possible for us to visit our client onsite, like we used to do with all customers pre-pandemic,” he added.
Thanks to the BSI CTMS subscription model, AMS will benefit from free annual product upgrades and a bilingual support in English and German.
About Advanced Medical Services
Founded in 1997, Advanced Medical Services (AMS) is an experienced CRO providing a full range of services to clinical trial sponsors, including Project Management, Monitoring, Quality Management, Biostatistics and Data Management, Pharmacovigilance and Medical Writing. AMS has been a European leader in the fields of Market Access, Health Technology Assessments (HTAs) and Rapid Relative Effectiveness Assessments (rapid REAs), and a pioneer in the benefit assessment of medicinal products in Germany. Its customers include world-leading pharmaceuticals, medical devices and biotech companies.
For more information, please visit: www.ams-europe.com
About BSI Life Sciences
BSI 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
