At the crux of CliniRx’s independent quality assurance (QA) group work is identifying/mitigating potential problems early on: giving rise to timely intervention so we can take corrective—and, when necessary, preventative—action.

With that said, we prioritize integrating QA team endeavors within each clinical trial step right from the get-go to ensure all trials fully align with Good Clinical Practices (GCP): guaranteeing participant safety and well-being while maintaining data quality/integrity.

Our conscientious QA team members also ensure our clinical development services align with International Conference on Harmonization (ICH) GCP guidelines and relevant laws as well as international regulatory authority expectations, with support spanning the following practices:

Service
  • Clinical Research: We ensure compliance with protocol, SOP, and regulatory guidelines with unfaltering emphasis on subject safety and data quality/integrity. Our services extend to reviewing critical documents such as clinical study reports (CSRs) and trial master files (TMFs), ensuring laser-sharp accuracy and compliance.
  • Risk Management: Striving to stay two (or ten!) steps ahead of potential challenges, we dive headfirst into risk assessments, categorization, proactive mitigation strategy, and ongoing risk monitoring to keep client projects on track throughout the clinical development journey.
  • Standard Operating Procedure (SOP): We design/develop tailored SOPs and procedures that not only align with relevant regulations and industry best practices but are also fully customizable per client-specific trial requirements.
  • Inspection-Readiness Support: As one of our core strengths, we offer comprehensive inspection preparation, attendance, post-inspection follow-up, and corrective action support to ensure robust compliance.
  • Vendor Management: These endeavors extend to vendor-qualification audits, vendor oversight, and performance-monitoring activities alongside vendor-compliance checks.
  • Audits: Our wide breadth of audits range from investigator site and vendor audits to process/system and GMP/GLP audits, ensuring client operations always rise to the highest standards.
  • Quality Management System (QMS) Implementation: This practice includes SOP development/updates, document control, and QMS reviews/audits to streamline processes (and thus breed success!).

Experience supporting small Biopharma bring New Drug to Market!

We’ll be happy to discuss further.