GCP Quality Assurance & Auditing
We support sponsors, CROs and investigational sites with Quality Assurance, Auditing and Monitoring services, in compliance with Italian regulations and international ethical standards, with a particular focus on Phase I units.
Management
From study start-up to closure, regulatory expertise and operational precision at every stage of your clinical trial.
Learn more →Monitoring
Precision oversight and compliance support across every trial phase.
Learn more →Quality
GCP QA and Auditing for Sponsors, CROs, and sites, with Phase I expertise, oversight, and risk prevention in line with regulations.
Learn more →Pharmacovigilance
Safety data management, case handling, and reports, ensuring accuracy, compliance, risk prevention, and patient safety.
Learn more →and Retention
Support to improve recruitment, retention, site performance, and patient access to best treatments.
Learn more →Training Program
Standard and tailored training solutions. Over 20,000 professionals trained via FormazioneNelFarmaceutico.com platform.
Learn more →Quality Assurance and Auditing Activities
ClinOpsHub has a dedicated department specialized in Quality Assurance and Auditing activities in compliance with GCP. ClinOpsHub experts support Sponsors/CROs and clinical sites to ensure compliance with the Italian regulatory framework and international ethical standards.
Main activities include:
- Drafting and reviewing Standard
- Operating Procedures (SOPs)
- Management of staff training
- Management of CAPAs (Corrective and Preventive Actions)
- Support during audits and inspections
- Support to self-certification process of Italian Phase I Units
In particular, ClinOpsHub demonstrates a strong commitment to supporting Phase I clinical units in achieving compliance with AIFA Determination No. 809/2015, in order to properly conduct Phase I clinical trials in Italy.
We provide the following services:
- Site Qualification Visits to assess the status of the site, identify any missing requirements, and provide support for self-certification
- Quality Assurance and Auditing activities to ensure compliance with the quality requirements outlined in AIFA Determination No. 809/2015
ClinOpsHub has extensive experience in the field, having supported more than 30 Phase I units in Italy. The experience gained in Phase I units enables a structured, effective, and quality-oriented approach to processes and data.
In brief
- GCP-compliant QA and Auditing support
- Verification of requirements for Phase I clinical units
- Support during audits and inspections
- Continuous oversight to ensure quality and safety
Why Choose ClinOpsHub
Services for Sponsors and Non-Profit organizations
Tailored solutions for both commercial sponsors and non-profit institutions, providing flexible and specialized support to meet the unique needs of each project.
Dynamic, Available, Flexible, and Up-to-Date Team
Our team is dynamic, flexible, highly available, and always updated with the latest regulatory standards, providing responsive and efficient support tailored to your project’s needs.
GCP-Compliant QA and Auditing
Rigorous quality assurance activities and auditing services in full compliance with Good Clinical Practice (GCP). We support over 20 Phase I units with self-certification (Determina AIFA no. 809/2015) and offer comprehensive Quality Assurance services to ensure data integrity and patient safety.
Clinical Trials Phase I–IV
Extensive experience managing and monitoring clinical trials from Phase I to Phase IV across various therapeutic areas, in compliance with regulatory and ethical international standards.
Experience with IMPs and Medical Devices
Expertise in handling Investigational Medicinal Products (IMPs) and medical device studies or investigations, ensuring full compliance with regulatory requirements.
Comprehensive Ethical and Regulatory Support
Full support for ethical and regulatory requirements, including CTIS management, ensuring that all aspects of the trial are in line with national and international standards.
For more information about our services or to assess how we can support your clinical study, contact the ClinOpsHub team: we would be happy to review your project’s needs and offer personalized solutions.
Request information
+39 0831 1987416