Audit Expertise

We provide comprehensive clinical audit services, fully compliant with Good Clinical Practice (ICH-GCP) and local regulations. Our expertise includes auditing Japanese sites in accordance with PMDA standards. Our services include, but are not limited to:

> Investigator site audits
> Vendor audits, Full service CRO (pre-contract/interim)
> eTMF audits
> Document audits
> Database audits

Quality Assurance
and GCP Consulting

We streamline clinical trial authorization processes and address general GCP queries, specializing in tailored solutions for client-specific issues. Our services include pre-inspection preparation for sponsors and investigator sites, managing quality issues, and overseeing audit and inspection follow-ups. We also maintain QMS systems, conduct root cause analysis, and prepare and complete CAPA plans.

Clinical Project Management

With 20 years of experience, Cliniqual Team excels in managing every aspect of clinical trials and project management throughout all phases and milestones of the study lifecycle. We employ a solution-oriented approach to enhance team performance and address challenges effectively. Our services include comprehensive budget and timeline management, optimizing patient enrollment prior to trial initiation, and providing strategic solutions for enrollment deviations. Additionally, we specialize in tracking delays, offering preventative measures, and implementing advanced concepts in vendor contract management and oversight, encompassing all clinical operations tasks.

Regulatory Services

We provide comprehensive support in preparing Clinical Trial Application packages for submissions across Europe, ensuring smooth approvals from Regulatory Authorities and Ethics Committees. Our expertise is fully aligned with EU Regulation 536/2014 and meets all Clinical Trial Information System (CTIS) requirements.