- Regulatory Affairs
- Clinical Operations
- Data Management
- Medical Services
- Quality Assurance
- Biotech Consultancy
- PRO Services
- Oncology Trials
- Internal Medicine Trials
- Observational Studies
- Medical Monitoring
Our deep experience paired with the use of advanced technology allows us to produce customised, reliable and cost-effective solutions.
We provide flexible and accurate data management solutions that ensure integrity, accountability and speed from database build to database lock. Our staff has extensive experience across a broad range of therapeutic areas and in different clinical phases, from small Phase I to IIb clinical trials to large Phase III to IV multi-sites and multinational studies.
We use advanced data management technology (Electronic/Remote Data Capture and Oracle Clinical ™) and our data managers and programmers are proficient in their use. Though, we do work independently from Oracle, in that we build, host, and support the system internally, relying only on Oracle for software upgrades and third level technical support. We have also used other tools such as Inform Datatrack and Omnicom.
We employ the processes, technology and expertise that better meets our clients’ needs. Pivotal can operate as a functional service provider, as part of a full service solution or on a standalone basis.
Services we provide:
- EDC/RDC or paper data capture (e-CRF design and development)
- Database set-up (design, development and validation)
- Randomisation system set-up/IWR randomisation system
- Double data entry
- Medical coding of events and medications (MedDRA and WHO Drug)
- Coordinated clinical data cleaning and QCs review
- AEs reconciliations (in paper and EDC systems)
- Integration and transfers of external third party data
- Database lock
- Flexible project management
Our data managers are also trained in the use of the latest standards including Data Standardisation (CDISC) and Integration.