About Us
···Services
- Regulatory Affairs
- Clinical Operations
- Data Management
- Biostatistics
- Medical Services
- Pharmacovigilance
- Quality Assurance
- Biotech Consultancy
- Patient Recruitment
Quality is the cornerstone of Pivotal’s success, it is valued at every step
Pivotal has an independent Quality Assurance department that reports directly to the CEO and that has built over years of experience a solid quality system to ensure the highest standards. This is accomplished by the following key elements: Quality Manual, Standard Operating Procedures, systems and project yearly internal audits and continuous staff training. We proud ourselves for being an audit and inspection-ready organisation.
Library of global Standard Operating Procedures:
Pivotal maintains its own corporate Standard Operating Procedures (SOPs) which govern all trial operations to ensure that activities are controlled, documented and conform to GCP. Our SOPs were designed and are monitored and regularly updated by a separate team with deep clinical expertise. When necessary, local specific and study-specific procedures may be prepared. Also, we have the flexibility to operate with our clients SOP’s when requested. All our SOPs are available for reviewing and auditing.