EXPERTISE THAT DELIVERS QUALITY RESULTS

• Clinical Project Management & Coordination from Phase I to Phase IV

• Setting up Clinical Operations (including SOP review & SOP establishment) - proven track record from EMA & FDA and local German authorities

• Clinical Trial Start-up Services including CRO Selection & negotiation

• Site feasibility and qualification
• Clinical Trial planning & conduct
• Co-Monitoring of clinical trial sites
• Implementation of Risk Based Monitoring approaches
• Recruitment strategies and materials development
• Development of various essential documents (eg: Investigator´s Brochure, Clinical Trial Protocol, Informed consent etc, eCRF development (incl. UAT))
• Implementation & maintenance of  a GCP compliant system for Clinical Operations
• TMF set-up, maintenance & quality control
• Financial Planning & Forecasting
• EU-CTR submissions (including redaction of documents)

     THERAPEUTIC AREAS

      I am covering a broad range of therapeutic areas:

• Cardiovascular diseases
• Immune system diseases
• Oncology (Hematology / Solid tumors)
• Skin and connective tissue diseases
• Pediatric indications
• (Ultra) rare diseases
• Rheumatoid Arthritis
• Gastroenterology
• ATMPs (Advanced Therapy Medicinal Products)
• Opthalmology
• Vaccines (COVID-19)