About ClinOpsHub
Expertise, quality, and continuous training in clinical research
About us
Our story
For national and international clinical trials
In compliance with international regulations
For clinical research professionals and entry level figures
Dedicated support and training
For integrated clinical research services
We build quality in clinical research. We support companies, clinical sites, and professionals with operational expertise, advanced training, and certified processes to ensure reliability, regulatory compliance, and scientific value.
Our Experience Across the Clinical Research Lifecycle
Over time, Quality Assurance and GCP auditing service have been complemented by specialized training programs, and Clinical Operations activities, support for Phase I Units, and strategic partnerships - enabling the delivery of increasingly integrated solutions.
The team has been involved in:
- Ethics Committee / Competent Authority submissions and contract negotiation with institutions
- Project management (study and site management)
- Site activation, monitoring, and close-out
- CTIS management
- Supporting data collection and data management
- Conducting GCP audit at Sponsor, CRO, clinical site, Phase 1 Unit, Laboratories
- Supporting the Certification process of phase 1 units as per the Italian Determina AIFA no. 809/2015.
- Training more than 20.000 students in clinical research fields.
Today, ClinOpsHub represents a multidisciplinary network combining operational expertise, continuous learning, and high-quality standards to support Sponsors, CROs, and clinical sites.
Milestones
An Amazing Success Story
Stefano Lagravinese starts his freelance career and sets-up and deploys the first Missione CRA training program for careers in Clinical Research
Publication of “Le Normative della Ricerca Clinica” (first edition), a booklet covering European and Italian clinical research regulations
Assisted its first Phase 1 Clinical Trial Units
Creation of Formazione Nel Farmaceutico: ongoing clinical research training platform
Partnership with a U.K. company involved in Patient Enrolment and Retention services
ClinOpsHub CRO is founded and registered to AIFA portal
Creation of Clinical Research Academy: specific training for clinical research personnel
Partnership with a U.K. company for Clinical Trial Submission
Began offering GCP audits with internal personnel as a service. In November 2021, ClinOpsHub certified its first auditor according to the requirements of DM 15.11.2011.
Creation Phase 1 Site Support – “Phase 1 Site Support” project
Creation of Phase 1 Academy: training for Phase 1 clinical trial personnel
CERICSAL (Centro Ricerca Clinica SALentino): start-up of a clinical trial center in Southern Apulia
International audits for Sponsors
Partnership with a German international CRO for Quality Assurance services
First internal ISO 9001:2015 auditor certification
Assisting more than 20 Phase 1 Clinical Trial Units (QA consulting, auditing, education)
UNI EN ISO 9001:2015 certification
Partnership with an Italian CRO located in Northern Italy
Partnership with a U.S. company involved in Patient Enrolment
Theseo - PNRR project acquisition
ISO UNI PdR 125:2022 certification
First submission in CTIS
Extension of the UNI EN ISO 9001:2015 certification to training in research and development (code IAF 37)
First CTIS Full study management (in compliance with CTR)
Opening of the Pre-Market Pharmacovigilance Department
Regulatory management of Medical Device studies (in compliance with MDR)
100° GCP audit conducted
Supported a CRO for the self-certification on AIFA portal
Supported a University with GLP certification, ensuring compliance of structures, procedures, and personnel.
Launch of the course “Diventare QA GCP”
Trained more than 20.000 students on the platform Formazione Nel Farmaceutico
Assisting more than 30 Phase 1 Clinical Trial Units (QA consulting, auditing, education)
OMNIA - PNRR project acquisition
Brand restyling and new logo
To ensure the success of clinical trials through tailored services, clear communication, and continuous training for clinical research professionals.
Talk to our team to learn how we can support your clinical research projects.
Join a dynamic clinical research network and develop new skills.
Trained Professionals
Supported Phase I Units
Years of experience
Focus on Quality
Meet Our Team
A multidisciplinary team dedicated to clinical research
Scientific Director & Legal Representative
Quality Assurance Manager & GCP Auditor
HR, Privacy & Legal Manager
Administrative Officer Manager
Training Project Coordinator
Clinical Project Associate & Pharmacovigilance Specialist
Training Project Coordinator
GCP Auditor & Quality Assurance Consultant
Information Technology Specialist
HR Generalist & Training Project Coordinator
Clinical Project Associate
Administrative Officer