- Regulatory Affairs
- Clinical Operations
- Data Management
- Medical Services
- Quality Assurance
- Biotech Consultancy
- PRO Services
- Oncology Trials
- Internal Medicine Trials
- Observational Studies
- Medical Monitoring
Our multi-specialty medical staff is the backbone of every trial conducted.
Pivotal’s medical team is talented, experienced, and fully versed in many therapeutic areas and ICH guidelines with an average of over 10 years of clinical research experience. They bring in-depth therapeutic expertise and strategic advice into the drug development programmes. We provide tailored risk-management strategies to optimise our clients’ product’s chances of making it to the market. We cover all main therapeutics areas, phases and stages of drug development: from protocol conception and expert medical monitoring services to review of final study reports and publications.
All our staff is assembled by professionals with medical degree backgrounds and PhDs or specialisations in different clinical and therapeutic areas offering our clients the specific knowledge and experience required for the trials success.
Services we provide:
- Clinical study report
- Study design & protocol development
- Develop inform consent forms
- CRF design
- Investigator brochure and IMPD development support and clinical review
- Therapeutic area consulting
- Medical interactions with CompetentAuthorities
- Medical monitoring plans
- 24-hour beeper on call medical monitoring for protocol queries and site support, medical/safety issues
- Investigator brochure development
- Regulatory support (IMPD Preparation & submission, approvals support and price negotiations)
- Scientific and medical support for project teams and sites
- Publications, posters, abstracts
- Support to R&D and marketing departments
Our medical team constantly interacts with key operational departments in order to access a fully-integrated network of information.