Monitoring & Auditing / Scientific Affairs
Comprehensive quality assurance, site optimization, and regulatory compliance frameworks.
Working for You
Our clinical team dedicates focus to individual protocols at a time. This lets us deliver deeply customized services while keeping study milestones on track.
Driven by global demands for cost-effectiveness, we optimize our clinical workflows to ensure sponsors extract maximum value from their research budgets.
Our specialized team guides you seamlessly through every phase of clinical development and complex international regulatory pathways—both pre- and post-submission.
Pre-Study Activities
ITClinical's monitoring staff identifies and qualifies top-tier investigational sites for your study, providing complete onboarding management and site readiness support.
We run a rigorous Feasibility Study tailored to your trial design and therapeutic area. Targeted Site Selection and Qualification Visits then minimize pre-study timelines and speed up trial initiation.
Clinical Trial Setup
Our clinical managers supervise complete Ethics Committee and Regulatory Authority Submissions, meeting complex regional timelines. Our integrated Language Affairs team handles certified translations and document localization loops seamlessly.
Maintaining a precise, dynamically updated Trial Master File (TMF) Repository remains a central compliance objective throughout the entire study lifecycle.
We organize Investigator Meetings end-to-end. Portugal is a premier European hub for clinical investigator assemblies.
Clinical Monitoring
Our field CRAs handle all critical onsite oversight. They cover Site Initiation Visits (SIV), regular monitoring, and final Close-Out Visits (COV), providing analytical reports to sponsors.
We optimize this process using our proprietary, fully compliant CTMS Platform.
During visits, CRAs perform Source Document Verification (SDV) and track adverse events. They also manage Drug Accountability logbooks and verify trial supplies.
Bioanalytical Monitoring
Regulatory scrutiny around bioavailability and bioequivalence (BA/BE) is growing. Sponsors now have greater obligations to ensure data alignment between clinical sites and bioanalytical labs.
Our experienced auditors provide critical analytical frameworks, including:
- Systemic monitoring and auditing of Phase I facilities and specialized bioanalytical testing centers.
- Comprehensive Phase I to IV clinical trial site monitoring.
- Independent clinical study auditing across diverse therapeutic indications.
Every audit follows strict EU mandates: Good Clinical Practice (GCP), Good Laboratory Practice (GLP), EMA Bioanalytical Method Validation guidelines, and Bioequivalence principles.
Third-Party Independent GCP Audits
Independent audits verify that your global teams comply with SOPs, GCP, GLP, and local regulations. This examination covers all trial-related workflows and tracking records.
True independence is vital for audits. Routine monitors are too close to daily operations to evaluate quality systems objectively.
Our auditing division covers Phase I pharmacokinetic trials through late-phase multi-center studies. We offer a full-package service: from audit design and site evaluation to reporting and CAPA tracking.