- Regulatory Affairs
- Clinical Operations
- Data Management
- Medical Services
- Quality Assurance
- Biotech Consultancy
- PRO Services
- Oncology Trials
- Internal Medicine Trials
- Observational Studies
- Medical Monitoring
Our QA unit has the right experience and is committed to earning our clients complete satisfaction.
Pivotal brings experience undergoing and performing auditing services, and, as such, will implement the learnt lessons from those audits in our clients programmes wherever and whenever applicable.
176 passed audits and inspections:
|# passed audits|
|Inspections||Health, local authorities, AEMPS & FDA||15|
|Third party trials audits||Investigators sites and in-house file||73|
|Internal audits||Investigators sites and in-house file||44|
52 audits performed by QA Pivotal to date:
|Type of audit||# of audits||Region||Multicenter|
|Trial master file audit||20||EU & US||Yes|
|Vendor audit||8||EU & Israel||–|
This ample experience allows us to successfully navigate through what to do and what to avoid.