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.
Stefano Milleri has presented results from a healthy volunteer study showing that IOA-289,
our novel #Autotaxin inhibitor,
lowered circulating levels of #LPA,
a blood-based biomarker of autotaxin inhibition, in a dose-dependent manner.
Compelling preclinical data show IOA-289 reduces tumor burden in mouse pancreatic cancer models.
This supports the decision to advance IOA-289 into clinical studies in
#pancreaticcancer, a malignancy typically characterized by a fibrotic and immune excluded phenotype.
Importantly, LPA levels have been shown to correlate with circulating CA19-9, a clinical biomarker of pancreatic cancer progression, providing a strong rationale for a biomarker-evaluable-response in this study.
The data on IOA-289 have been presented in a poster (P131) entitled “Translating a novel autotaxin inhibitor from preclinical proof of concept in pancreatic cancer to a biomarker response in human subjects”. The poster is available here.
(click HERE to read the document)
Il CRC attribuisce una borsa di studio per un/una CTA.
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.