We love our customers and are pleased by every new success story that we are able to tell here. In the following, discover a selection of our customers and peek inside the exciting projects that we have been able to carry out with them. To be continued.
Curadel Surgical Innovations, Inc. (CSI; Boston, MA, USA), a mid-sized medtech manufacturer, needed a clinical trial management system (CTMS) with an integrated eTMF that could be rapidly adopted to conduct a new series of global clinical trials spanning two continents.
Charité Universitätsmedizin Berlin, one of the largest and most prominent university research hospitals in Europe, has selected BSI’s Clinical Trial Management System (CTMS) and Electronic Trial Masterfile (eTMF) solutions to support the success of internal and external clinical trials at the prestigious biomedical institution. BSI’s implementation with Charité began mid-April 2021, with a planned go-live in August 2021
Kirkland, USA based Cardiac Dimensions will go live with BSI’s electronic Trial Masterfile (BSI eTMF) in September 2020, before adding more CTMS functionality over time through pure configuration. The first implementation meeting took place on 1st July and go live is scheduled for 30th September. The three-month timeframe maintains BSI’s impressive track record in rapid turn arounds.
BSI has replaced the existing system for the planning and management of clinical trials with BSI CTMS at ALK-Abelló, the specialist for allergy therapy with headquarters in Hørsholm, Denmark. The system is depicting the complete trial process of this globally active manufacturer of allergy vaccines, down to the level of individual patients.
The solution is based on the BSI CTMS Standard 5.5 and covers the entire range of study planning and supervision, including monitoring, patient tracking and document administration (eTMF). An upgrade to the next BSI CTMS Standard 5.6 shall follow in a second release, which will be expanded to HR Management, Business Development, Activity Planning and Tracking, including offer generation and billing, turning BSI CTMS for the CRO Dokumeds into a complete “ERP system”.
OCT is a leading full-service CRO that operates on behalf of well-known pharmaceutical and biotech companies. With a team of over 200 experts, OCT offers its customers the entire bandwidth of clinical trials and services that comprise project management, monitoring, data management, and statistics.
The internationally successfully dermatology CRO, proinnovera, is using BSI CTMS to conduct its clinical trials. A total of 100 employees work at the proinnovera headquarters in Münster, Germany. An additional 980 employees can access the solution in more than 40 other countries. With BSI CTMS, trial managers can constantly access all relevant information in real time and have all modules for trial management, monitoring of the trials centers, document administration, reporting and more depicted in a single solution.
Occlutech was founded in Germany in 2003, and has since developed into one of the world´s leading suppliers in the area of structural heart disease with products and projects for; congenital defects, stroke prevention, and heart failure. The company´s products are sold in over 80 countries globally and the total number of implantations is approaching 80.000, setting the highest standards regarding quality, outcomes and patient safety.
Luminex Corp based out of Austin, Texas will be working with BSI CTMS for clinical trials management. The project will involve setting up a standard interface to IBM® Clinical Development that Luminex are already using. The go-live of BSI CTMS for Luminex is expected in June 2020.
BSI announces that it has been awarded the contract for the supply of its Clinical Trial Management System (CTMS) to Avillion LLP. Avillion is a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval.