Our services include consultancy for and medical surveillance of clinical trial and drug safety projects. Writing of documents crucial for drug development and drug safety is scientifically driven and based on experience in more than 100 clinical trials, various indications and many years of experience in pharmacovigilance.
Writing a document is thoroughly planned, usually two review cycles are included and a comments resolution TC is held to solve pending topics. We are prepared for developing approaches to innovative ideas together with you. If there are hurdles and bottlenecks we will support you to overcome them.
Drug Development
- Consultancy early clinical development, also as member of Project Teams
- Clinical Trial Physician and Medical Monitor for single-ascending dose (SAD)/multiple-ascending (MAD), first-in-human, drug-drug or drug-food interaction, hepatic/renal impairment, bioavailability (BA), bioequivalence (BE), biosimilarity, proof-of-mechanism (POM) or proof-of-concept (POC) clinical trials including those with integrated protocols and adaptive features
- Writing Documents
- From Clinical Trial Synopsis, Protocol to Report
- Common Technical Document for Marketing Authorisation Application: 2.5 Clinical Overview, 2.7.2 Summary of Clinical Pharmacology Studies, 2.7.4 Summary of Clinical Safety
- Responses to Questions / Requests from regulatory authorities
- Contribution to Briefing Books for Scientific Advice
- Publications
- Chair or Member of Risk-Benefit-Committees/Dose Escalation Committees
- Improving efficiency and quality of processes
- Training Junior Scientists
Drug Safety / Pharmacovigilance
- Aggregate Reports: Each document writing is thoroughly planned, usually 2 review cycles are included and a comments resolution TC is held to solve pending topics.
- EU Risk Management Plans (RMPs) according to Good Pharmacovigilance Practice (GVP) V
- Development Safety Update Reports (DSURs) according to ICH E2F
- Periodic Benefit-Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR) according to ICH E2C(R2) and GVP VII (including Explanatory Note)
- Signal Management according to GVP IX
- Safety Evaluations
- Surveillance of Safety Teams
- Chair or Member of Safety Boards