Who we are
ClinOpsHub was founded in 2014 by Stefano Lagravinese as a one-man company. After years of providing services to various clients in the field of Clinical Research, in 2019 ClinOpsHub was registered as a Contract Research Organization (CRO) on the AIFA website in compliance with the requirements of the Italian D.M. 15.11.2011.
We provide services and support to Pharmaceutical Companies, Hospitals and other CROs at national and international level, ensuring high quality thanks to a team extensively trained as required by Good Clinical Practice (GCP).
We adhere to high ethical standards and perform in compliance with policies and procedures. Accuracy and quality of clinical trial data are crucial to us.
“Coming together is a beginning; keeping together is progress; working together is success.”
Customer satisfaction is our added value. We offer our customers high quality services, a reliable and expert support to navigate the ever-developing world of Clinical Research, and our commitment to ensure a successful Clinical Trial process.
We guarantee flexibility and accommodate your requests, by providing tailor-made services.
Effective communication and successful performance are our mantras.
Quality Assurance System
ClinOpsHub has a quality assurance system that complies with the Good Clinical Practices (GCPs). It is regulated by Standard Operating Procedures (SOP), in compliance with regulatory requirements and its company policy.
All ClinOpsHub team members are properly trained on SOPs according to the functions they perform, and are trained compliant to the requirements of the Italian DM 15/11/2011 for the performance of technical-scientific and QA activites.
ClinOpsHub is in the Register of self-certified CROs with AIFA as it meets the minimum requirements foreseen by the Italian DM 15/11/2011.
ClinOpsHub is a fresh CRO active in Southern Italy, that is already making a difference in the Clinical Research world.
We are a dedicated team focused to results.
We share knowledge and provide effective advice.
If you have tight deadlines, we are the answer at competitive prices.
We feel your needs. Your project becomes our project.
We manage different aspects of Clinical Research in accordance with the current legislation.
Our services include:
We provide full-service execution of clinical trials, managing them in all phases from I to IV. We listen to your needs and ensure efficient management of site workflow to deliver high quality data. From start-up to completion, we monitor performance on a regular basis making sure it reflects timelines and budgets.
Clinical Trial submission
Our team takes care of the ethical and regulatory submissions to the Ethics Committees and Competent Authorities through the use of OsSC. For us every step counts and we apply accuracy and know-how.
We perform all monitoring activities for sponsored and non-profit studies, from phase I through phase IV, verifying that each single activity is conducted in compliance with applicable regulations. We offer study file setup, and CRF design, as well as a tailored-made Informed Consent Form to suit each individual study, in line with local regulatory and sponsor requirements, and written in such way that it is effective and easy to grasp for patients.
Our mantra is communication; we achieve set objectives through the constant collaboration and interaction amongst our team, the Sponsor and the Experimental Centre. We guarantee you have a clear picture of what is happening.
Site Qualification Visit, in order to verify the centre status, to highlight the missing requirements and to provide support for the self-certify
Quality Assurance Activities, in order to be in compliance with the requirements described in Determina AIFA n. 809 2015
We provide effective support to the Centre for the enrolment and retention of patients. We are always present by keeping in contact, preserving the quality at all times, performing tasks remotely, but when necessary face-to-face. Our team is trained to analyse processes, detecting criticalities and suggesting the most effective solutions.
Organization Investigators Meetings
We offer the organization of Investigators Meetings, aware of the importance that these pre-trial events play in the smooth running of a Clinical Trial. During the meetings our team is ready to deliver presentations in order to give a comprehensive picture of the program, assessment of the risks and benefits, and the approach/design of the Clinical Trial.