iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials
This summer ABX-CRO and Flex Databases signed a contract for a CTMS & eTMF implementation. We asked Dr. Ulrike Schorr-Neufing, Director, Qualification & Training, ABX-CRO, a couple of questions about the upcoming partnership.
Why ABX-CRO decided to pick Flex Databases as a provider?
After an intensive selection and evaluation process comparing different service providers ABX-CRO decided to select Flex Databases. Main deciding factors are the possibility of on-premise solutions for CTMS and eTMF as well as the flexibility of the different modules for managing clinical trials. Furthermore, Flex Databases meets ABX-CRO requirements regarding user-friendliness and interaction with internal software solutions very well.
What do you expect to achieve with the implementation of Flex Databases?
We expect significant improvement and facilitation of management tasks both on company level as well as on project level. The implementation of an eTMF is expected to ease maintenance and inspection readiness of Trial Master Files. Overall, we expect to increase our quality and cost-effectiveness by using this standardized software solution for our business activities.
ABX-CRO is a globally operating full-service contract research organization with a strong focus on the development of radiopharmaceuticals and molecular imaging. Based on over 20 years of experience in diagnostic and therapeutic oncology, neurology and other disease areas, ABX-CRO provides you with unique opportunities to test your drug candidates in all phases of drug development starting from first non-clinical to complex late-stage multi centre human studies including solutions for radiolabelling, dosimetry, regulatory issues and the intricacies of functional imaging that are frequently seen as major obstacles in the conduct of oncology and imaging trials.