In 2005 our CEO Sven Engel was a managing director of the CRO he founded. During that time, he held a responsible position at the Jerini Ag and contributed in the clinical development of a drug against the rare disease of hereditary angioedema.
After the takeover of Jerini by Shire Ltd., he was responsible for the further projects up to FDA approval. The CTM system EasyClin(c) which he had developed, was used in two global studies and thanks to this new, oustanding system, he was able to keep the calculated time and cost framework at 100%.
The system then got validated in 2010 according to 21 CFR part 11. Moreover, it got approved by the client and accepted by the FDA.
Studies usually lead to long delays and high costs due to manual post-proccessing. This can now be avoided with the use of our systems. At peak times, up to 250 users worldwide (doctors, laboratories, CRAs, etc:) at the same time use one single installation.