Dr. Schumann provided Consulting Services and Interim Management in Europe and the USA.
Case studies:
- 1: Interim Management - Head Clinical Development
- Provision of leadership in the Phase III development of an orphan drug.
- Result: Successful timely completion of all pivotal Phase III studies to file a BLA.
- 2: Crisis Management - Health Authority meta-analysis request
- Coordination of retrospective CRF data entry after the MHRA requested specific data from a pharmaceutical company (increase in frequency of SAE reports).
- Result: 200+ FTEs in 18 countries were trained and supervised to enter 1,000,000+ CRF pages from more than 70 clinical studies into an Electronic Data System (EDS) within 2 months. Meta-analysis of data conducted by Sponsor to provide requested information to MHRA within the requested timeframe.
- 3: Crisis Management – FDA recall
- Coordination and follow-up of all patient/physician and legal requests after FDA recall of 2 drugs due to SAEs reports.
- Result: 50 FTEs were trained and supervised on how to follow-up on SAE reports with physicians and patients and enter all available information into a database. Information from more than 10,000 patients could be retrieved and analyzed.
- 4: Consulting - Global Process Improvement
- Development, documentation and implementation of global processes for a pharmaceutical company.
- Result: Development and facilitation of workshops for all operational departments in R&D, SOP and process flow chart development (50+ SOP’s), worldwide training of SOPs and associated documents, transfer of SOPs into e-Learning system.
- 5: Consulting - CRO Partner Search
- US Partner search for a European mid-size CRO.
- Result: Screening of 100+ US CROs, establishment of contacts to CROs and presentation of 3 top candidates to the sponsor according to predetermined criteria. Partnership contract signed.
More information as well as specific references can be provided upon request.
