Our team comprises seasoned pharmaceutical physicians, with over a decade of experience in planning and implementing clinical development programs, involving small molecules and biologics, for biotech and pharmaceutical companies.
The broad therapeutic expertise (e.g. infectious diseases, ophthalmology, gene therapy, pediatrics, rare diseases) and specialist skills (e.g. innovative adaptive trial designs, patient level meta-analyses, exploratory biomarker analyses) ensures pragmatic solutions at every stage of clinical development.
- 24/7 support to site personnel
- Advising sites on patient eligibility, and management of adverse events
- Medical data review for clinical coherence, and query resolution prior to database lock
- Providing investigator/site training
- Developing medical monitoring plans
- Study protocols, clinical study reports, investigator brochures
- Health authority briefing documents, responses to health authority questions
- Conference abstracts, and journal manuscripts
- Narrative writing
- Defining clinical development plans and target product profiles
- Supporting advisory boards and health authority meetings
- Medical and scientific literature reviews
- Project Management
- Data Management
- Biostatistics