About Us
···Services
- Regulatory Affairs
- Clinical Operations
- Data Management
- Biostatistics
- Medical Services
- Pharmacovigilance
- Quality Assurance
- Biotech Consultancy
- Patient Recruitment
Our QA unit has the right experience and aspires to excellence by providing quality support and achieving full customer satisfaction.
Pivotal brings experience in hosting and conducting auditing services, and implementing the lessons learnt from these audits into the client active research programmes.
204 passed audits and inspections:
| # passed audits | ||
|---|---|---|
| Inspections | Competent Authorities: AEMPS, AIFA, FDA, EMA, DMA & Local Health Authorities | 15 |
| Third party trials audits | Investigators sites and in-house file | 77 |
| Facility audits | In-house | 62 |
| Internal audits | Investigators sites and in-house file | 50 |
57 audits performed by QA Pivotal to date:
| Type of audit | # of audits | Region | Multicenter |
|---|---|---|---|
| Trial master file audit | 22 | EU & US | Yes |
| Site audit | 16 | EU | Yes |
| System/Process audit | 10 | EU | – |
| Vendor audit | 9 | EU & Israel | – |
This ample experience allows us to successfully navigate through what to do and what to avoid.
