“Opdracht werd volledig binnen de verwachtingen uitgevoerd. Feedback over status en resultaten was excellent.”
- Datum van beoordeling: 23-03-2017
- Positie of opdracht: Customer Trainer
- Locatie: Zuid-Afrika
- Budget: €25000
- Datum geleverd: 01-10-2016
“Opdracht werd volledig binnen de verwachtingen uitgevoerd. Feedback over status en resultaten was excellent.”
“Wim Ekkart was fully and deeply involved in setting up the IT and quality infrastructure of imagine-SCT, a medical imaging company for clinical development studies for the pharmaceutical industry. He developed the IT design and performed the set up of the imaging platform from the "user requirement specifications" through the validation according to FDA CFR21, Part 11 and EudraLex Volume 4, Annex 11. He did this in such an excellent way that he was asked to take on the responsibility of "Chief Information Officer". He also was deeply involved in the business development discussions with clients. Due to his broad experience in radiology he also performed, e.g. the draft evaluations, which were validated by a board certified radiologist, usually without changes of MRIs for a clinical study performed in clinics in the US and Japan. Through the duration of our co-operation Wim acquired the expertise of GCP related to IT issues and was always extremely reliable. He also managed successfully several audits of the IT systems for compliance with FDA CFR21, Part 11 and EudraLex Volume 4, Annex 11. According to my previous experience with quite a number of IT managers, Wim is an outstanding IT expert able to deliver even under very severe regulatory requirements. Gerd Johnscher, ex COO imagine-SCT”