M.A.R.C.O.’s expertise was consulted for the planning and execution of many studies including Phase I, II and III trials as well as non-interventional studies.
Additionally, a considerable number of expert reports were provided for various medicinal products and different indications. These included clinical expert reports for regulatory purposes, phase I expert reports for regulatory purposes, and expert reports focusing on pharmacokinetic and/or statistical issues.
Furthermore, M.A.R.C.O. is experienced in the preparation and discussion of protocol outlines for different competent authorities (EMA, WHO, FDA, PMDA – Japan, BfArM, IQWiG). Especially during the last years, M.A.R.C.O. attended several face to face meetings with competent authorities.
M.A.R.C.O. performs training courses in different aspects of clinical trial design, statistical analytical methods and indications for clients and organizations (e.g. workshop “Design, Conduct and Analysis of Biomarker Studies”).
Pharmacokinetic analyses were performed for many studies including studies investigating bioequivalence, drug-drug interaction, food-drug interaction, or ethnical differences.
Modelling and simulations were carried out for various studies of different indication. M.A.R.C.O. uses Phoenix® WinNonlin and NLME for analyses.
- Various publications in the fields of pharmacokinetics, epidemiology, statistical methods and strategies
- Lectures and poster presentations in scientific meetings and conferences
- Organization / contribution to statistical and data management workshops