Consulting
Competitive landscape
In today’s R&D world there is no success without in-depth therapeutic expertise to support Trial Execution
Our Experts
Dr. Ingrid Klingman
Dr. Ingrid Klingmann, physician, specialised in general medicine, clinical pharmacology and pharmaceutical medicine. 30+ years of experience in ethical, methodological, regulatory, and managerial aspects of Phase 1 to 4 trials. Successful track record of Phase 1 and complete drug development planning and management from the sponsor, investigator site, and CRO perspectives. Experience as medical monitor in a variety of different areas of indications. Profound knowledge in ethical, regulatory, and quality requirements of clinical trials. Long-standing experience in practice-oriented training in GCP, clinical trial management, ethical and regulatory aspects of clinical research.
Services:
- Advice on trial, phase and complete development strategies
- Critical review and concrete improvement support to R&D-related documents
- Solution finding
- Constructive interaction with ethics committees and competent authorities
- Management improvement support for sponsors, CROs, and sites
- Training
- Enabling of patient engagement in R&D processes
Prof. Paul Rolan
Prof. Paul Rolan is a pharmaceutical physician and clinical pharmacologist with extensive experience as an investigator and consultant in early phase and proof-of-concept studies. He offers consultancy on the design and execution of efficient exploratory development programs with special focus on first-in-human studies in patients in non-oncological therapeutic areas. In additional to being the Medical Director of the UK’s largest Phase 1 unit, where he was PI in over 700 studies, Prof. Rolan has worked in the pharmaceutical industry which included roles such as Head of Clinical Pharmacokinetics; Chief Medical Officer and Director of Drug Development. He has experience of dealing with the FDA and other regulatory bodies. He is on the Scientific Advisory Boards of Australian and international biotech companies.
Robin Michelet
Robin Michelet a renowned specialist in Pharmacometrics, having wide professional expertise and a profound knowledge of the relevant market. Consulting Services cover but are not limited to: conducting professional trainings, clinical trial management, site management support, review of clinical trial assumptions / documentation, contacts with specialists, advisory services (i.e. regulatory strategy, regulatory affairs).
PhD Bogdan Podwysocki
Prof. Paul Rolan is a pharmaceutical physician and clinical pharmacologist with extensive experience as an investigator and consultant in early phase and proof-of-concept studies. He offers consultancy on the design and execution of efficient exploratory development programs with special focus on first-in-human studies in patients in non-oncological therapeutic areas. In additional to being the Medical Director of the UK’s largest Phase 1 unit, where he was PI in over 700 studies, Prof. Rolan has worked in the pharmaceutical industry which included roles such as Head of Clinical Pharmacokinetics; Chief Medical Officer and Director of Drug Development. He has experience of dealing with the FDA and other regulatory bodies. He is on the Scientific Advisory Boards of Australian and international biotech companies.