Clinical Research – special focus
The Phase of Clinical Trials plays a key role in the early life cycle of a medicinal product. Now it will be decided, whether a promising new molecule designed in a lab also provides safety and efficacy in humans. As far as new medicinal entities are concerned, now it is time to organize a huge Clinical Trial program, requiring quite often more qualified personnel for a certain timeframe. My expertise in Clinical Research – Project management is based on the following experience:
1) For about 2 years I have been the project leader for international multicenter Clinical Trials (phase II-III) in the indication of antiinfectives (about 40 sites in 5 EU- countries). This task included not only operational responsibilities such as investigator meetings, study initiation, on site monitoring or close out: Moreover I have been involved in the preparation of the statistical analysis plan and the data evaluation specifications based on it, I have been supervising the activities for Data Base Locks according to timelines. I have developed a Data Query Tracking System and I have written a Final Study Report. I was lead CRA, supervising more than 10 freelance CRAs from different nations (monitoring 2 sites myself) and I was the liaison person with the sponsor. During this time I have learned a lot about the motivation of colleagues in different teams as well as constant caretaking/consultancy for investigators in special situations (e.g. unblinding, SAE death or pregnancy)
2) In the postgraduate studies ‚Master of Drug Regulatory Affairs’, concluded 2007, wherein all relevant scopes regarding DRA have been taught, I have also studied the module ‚Clinical Reseach’. In this context I have learned the new legislative environment such as Clinical Trial Directive and its implemen-tation in terms of CTA submissions and new requirements of submissions to the ECs (German Drug Law). Another module dealt with Medical Devices.
3) In one of my former engagements (BMS Munich) I have worked in Drug safety. Therefore I have gained knowledge of clinical study protocols because of the recherche for SAEs and SUSARs (mainly TA oncology). Hence, during my work as a regulatory scientist I have been responsible for approving advertising material consisting mainly of study data. Among those there were also scientific presentations (from external experts as well) for investigator meetings and other events (e.g.training) for physicians and scientific experts. This required me to have an in depth knowledge and understanding of the study designs to review the results of the advertising materials/presentations. The indications I was responsible for were HIV, antiinfectives und CNS.
4) At my last engagement (MEDA Pharma Bad Homburg) I have been working as a project manager, mainly in preparation of Marketing Authorisation Appli-cations – Dossier compilation. In the scope of this task it was important for me as a DRA Manager in the HQ of the company to stay in close communication with the affiliates in more than 20 EU-countries and to co-ordinate the prepa-ration of a multinational DCP. I have also been member of internal interdepart-mental teams to develop strategies for Clinical overviews/ Expert reports to-gether with our collegues from Clinical Development. Finally, I have reviewed internally the results in their draft documents before submission, focusing on the thought: Will this convince the competent auhtority? Moreover I have pre-pared a worldwide PSUR for a product group from the TA allergy/ asthma for more than 80 countries. Conclusion: there are so many connections between project management DRA and project management Clinical Research that I have kept myself updated regarding Clinical Research any time.
Ellen Güttler
Neustraße 9
67578 Gimbsheim/Rhein
Germany
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Hintergrundfoto: (c) Rainer Sturm / pixelio.de
