About Us
···Services
- Regulatory Affairs
- Clinical Operations
- Data Management
- Biostatistics
- Medical Services
- Pharmacovigilance
- Quality Assurance
- Biotech Consultancy
- Patient Recruitment
Our knowledgeable Quality Auditors help companies to track and achieve high quality standards.
In addition to assuring Pivotal’s quality standards, our Quality Assurance (QA) department provides stand alone quality assurance services to support companies to develop, implement and update their quality systems and procedures to conform to GCP guidelines and regulations as well as to provide auditing services to third parties clinical vendors. We have in-house resources to cover your auditing requirements for all phases I to IV clinical studies.
Services we provide:
- System audit (SOPs, processes and staff training)
- Clinical site audit
- Trial master file audit
- Protocol and ICF audit
- Clinical study documents audit
- Clinical database audits
- Laboratory audit
- Vendors audit
- Support clients in the preparation for Regulatory Bodies Inspections
- GCP training services
Our QA staff has conducted QA programmes for clinical trials throughout many sites and regions. We offer our clients customised and flexible models, from complete to partial or tailored QA programmes, according to our clients’ requirements.
