Quality Assurance & Control For Clinical Research

Quality is the cornerstone of Worldwide Clinical Trials.  Everything we do springs from a formidable quality assurance (QA) and control system. All details of your protocol are strictly followed; standard operating procedures (SOPs) are written to anticipate improbable outcomes. Good Clinical Practice per the International Conference on Harmonisation is a given; and local, national, regional, and international legal, ethical, and regulatory requirements are always top-of-mind. We maintain audit-ready status. However, QA is not just about compliance for us. Our collective eye is on protection and safety of subjects and integrity of clinical trial data.

We don’t rest on our well-earned reputation for high-quality or relax our ideals. We treat every project as an opportunity to apply lessons learned and excel again. Relationship building with us is not about settling into a groove, but continuing to impress you and meet your needs.

We have operationalized best practices. We encourage our employees to continually improve processes, and we provide in-depth QA training and a clear QA policy. Worldwide Clinical Trials is a gold-level member of the Clinical Data Interchange Standards Consortium (CDISC), and our work aligns with CDISC standards. Our services include QA consulting and audits performed by experienced quality management specialists. With personnel spread across the globe, we can provide QA audits in most local languages.

Quality assurance at Worldwide Clinical Trials means:

• Documented procedures
• Validated methods and technologies
• Frequently updated SOPs
• Easy retrieval of essential documents to show actions, decisions, and results
• QA training for all stakeholders (eg, vendors, trial sites, sponsor personnel)
• Close and careful monitoring of all aspects of your clinical trial; for example:
  • Site and country selection
  • Screeners and raters
  • Electronic data capture
  • Database lock
  • Interpretation and statistical analysis
  • Medical writing
• Internal and external audits performed by independent auditors.