Earlier this year SocraTec R&D, a CRO from Germany, selected Flex Databases as an eTMF vendor.
We asked CEO André Warnke a couple of questions about the upcoming partnership:
- Why SocraTec R&D decided to implement Flex Databases eTMF?
As full service CRO with all kind of clients from small/mid-sized companies to globally operating corporations, SocraTec R&D is dedicated to highest quality and user-friendly solutions with stringent focus on efficiency and cost-effectiveness. We have been working with several other eTMF systems in the past and the long-term experience as well as the broad product overview allowed us to set-up extremely well-defined User Requirement Specifications.
Many eTMF systems have very good if not even excellent features but often staff training is time consuming due to a lack of intuitive handling, costs per study are quite high and – important for an independent Contract Research Organisation with a broad variety of clients – provider independent archiving is not well supported.
Flex Databases fully convinced the management as well as the operating departments of SocraTec R&D and – even more challenging – our experienced QA department.
2. Why did you choose Flex Databases as your eTMF?
After an intensive testing and comparison phase of different providers we chose Flex Databases since we were able “to tick all boxes” on all of our different requirements, e.g. well-designed and user-friendly interface, data security, validation and flexibility for all different kinds of clinical trials.
Furthermore, SocraTec R&D has an established cooperation with August Research for the conduct of multicentre, multinational clinical trials Europe-wide and in the US. Since both companies are now using the same provider, we gain the big advantage for even more seamless teamwork over different countries and time zones. We consider this a huge additional benefit.
3. What do you expect to achieve with the implementation of Flex Databases?
The Flex Databases eTMF System will allow us to make essential documents available in real-time to clients and partners around the world and thus tighten our co-operations. We expect maintaining our high-quality standards also with this crucial step towards paperless documentation, without losing our flexibility for specific solutions for each clinical trial. We also see the possibility to a more efficient tracking of document flow and the possibility to assure inspection readiness of Trial Masters Files more easily.
Furthermore, the eTMF fully supports the DIA reference model and therefore allows stringent and continuous application of current state-of-the-art requirements in each project.
SocraTec R&D – a company profile
SocraTec R&D, a mid-sized clinical CRO was founded in 1998. From the beginning the company was dedicated to early phase clinical trials in healthy volunteers, extending the activities towards patients and later phases during their history. The key staff members of the company have far-reaching experience from many years in drug research and development.
From the beginning SocraTec R&D was set-up with a modern quality Quality Management management concept strongly influenced by GLP- and GCP-principles. All processes are embedded in a comprehensive Quality Management under the supervision of a highly experienced and independent QA-group. Biometric services follow the standards of 21 CFR Part 11. SocraTec R&D is frequently audited by all types of pharmaceutical companies and has been inspected by national EU-agencies, EMA and FDA as well as by ANVISA.
