- Advice for early clinical development strategies from first in human studies through Proof of Concept.
- Preparation of early clinical development plans and translation of pre-clinical results to strategies for clinical development.
- Development of clinical pharmacology strategies during late stage development.
- Clinical pharmacology support for post-marketing changes such as new formulations or additional indications.
- Design and analysis of clinical trials, especially phase 1/2a clinical trials and other clinical pharmacology trials, including ethnic sensitivity, thorough QTc, drug-drug interaction, paediatric, bioavailability and bioequivalence trials.
- Preparation of study and project related documents such as study protocols and reports, Investigator’s Brochures, Informed Consents and safety reports.
- Preparation of documents for regulatory submissions e.g., Common Technical Documents, Investigational New Drug and New Drug Applications.
- Project management for Clinical Pharmacology programs
- Study management for phase 1/2a and other clinical pharmacology studies.