The CRC specialises in designing and executing Proof-of-Concept studies using targeted populations, state-of-the-art technology and human disease.
A full range of Clinical Pharmacology services is also provided (e.g. single/multiple ascending dose, drug-drug interaction, pharmacokinetics, food effects, bioequivalence) by means of an in-house Clinical Pharmacology Unit, equipped to the highest standards and operating in close connection with specialist intensive care expertise in Cardiology, Anaesthesiology, Internal Medicine, Surgery and Neurology.
The CRC is in full compliance with International Good Clinical Practice (GCP) standards and is Certified according to the UNI EN ISO 9001:2008 standard; transition to the 9001:2015 ISO standard has been completed in 2018.
The CRC Quality Management System (QMS) comprises our mechanisms for ensuring that all our services are performed to the highest ethical standards, conform to all regulatory requirements and satisfies contractual obligations.
We continually improve the effectiveness of its QMS through a systematic approach, starting from defining and planning strategy and objectives in order to standardize implementation and compliance by a defined Quality Policy and procedures, checking effectiveness and compliance by QA, QC, Management Review, data and project review, audits and customer survey results.
We are pleased to announce the start of the RT-CoV-2 clinical trial to evaluate the safety and efficacy of the new vaccine to prevent SARS-CoV-2 infection. The study is aimed at healthy subjects aged 18 to 55 years and 65 to 85 years.