Our staff provides the expertise necessary to ensure smooth and efficient implementation of clinical trials. The benefits that the CRC can offer to Sponsoring Institutions include:
- Timely approval of the study by the Ethics Committee
- Timely contract and budget negotiation leading to rapid study initiation
- Efficient study coordination and monitoring from study initiation to study termination
- GCP training of personnel
- Quality Assurance
- Large pool of available volunteer/patients
- Protocol development

The outcome of any clinical trial depends upon the accurate and timely gathering of research data. At the CRC, each clinical trial is coordinated by expert Study Coordinators who provide the highest standards in clinical research.

Study Coordinators

Study Coordinators provide day-to-day support to the CRC personnel and work with sponsors for a timely initiation of the study. Study Coordinators are an invaluable resource to guarantee high quality training of the staff in Good Clinical Practices (GCP) and Standard Operating Procedures (SOP). Our Study Coordinators also contribute to the development of innovative trial-management strategies to maximize efficiency.

Areas of expertise

Allergy & Clinical Immunology,
Bioinformatics,
Cardiology, Hypertension & Dyslipidemia,
Critical Care and Emergency Medicine,
Dermatology,
Diabetes & Endocrinology,
Gastroenterology/Hepatology,
Infectious Diseases,
Nephrology/Urology,
Neurology,
Ob/Gyn & Women's Health,
Oncology,
Ophthalmology,
Orthopaedics and Traumatology,
Pharmacology & Toxycology,
Public Health & Prevention,
Respiratory Disease,
Imaging ,
Rheumatology.

In particular, the CRC activities are focused on three major research areas: Primary Care, Neurology, and Oncology. These research areas are coordinated and supervised by our Program Director, Professor Andrea Mezzetti, and the CRC Advisory Committee that gathers a panel of experienced clinicians with academic background.

Cardiovascular Diseases
Age-related mechanisms are studied (inflammatory/anti-inflammatory and oxidant/antioxidant balance), which can amplify the effects of other risk factors (e.g. Hypercholesterolemia, hypertension and diabetes mellitus) on the determinants of atherothrombosis and its consequences.

Cancer
Studies are carried out to identify novel markers for early diagnosis and prognostic evaluation of the relevant tumors in the elderly. All recent advances in the fields of cell biology, immunology and non-conventional therapies are investigated to prevent and improve treatment protocols of malignancies in the elderly.

Neurodegenerative Diseases
The most frequent neurodegenerative disorders in the elderly are studied, like Alzheimer's, Lewy-Body's dementia and Parkinson's syndromes. Degeneration markers are characterized through biological and imaging techniques. The natural disease progression is compared with the various experimental disease models, assessing the effectiveness of new therapeutic interventions.

CRC has already set collaborative projects with the following sponsors:

Industry-Sponsored Clinical Trials

In an attempt to decrease redundancy when submitting a proposal to CRC, the Business Office has streamlined the application process by having a combined CRC/Ethics Committee application. In addition to completing the Ethics Committee application, please be sure to include the following documents when requesting CRC services:

Study Proposal form: the form collects information about the principal investigator or about the industrial sponsor proposing the study.
Study Synopsis form: the form is a collection of information pertaining to the protocol. The CRC uses this information to identify areas that may need special consideration during the reviewing process.
Ethics Committee checklist: this form is a list of all required documents to be submitted to the Università G. d’Annunzio Ethics Committee.

Review Process

After receipt of relevant documents, the CRC will review the information and present the study proposal to the feasibility committee. The feasibility committee meets twice a week and reviews study proposals on the basis of costs and availability of technical and human resources. The reviewing process is usually completed within a week and immediately communicated to the applicant.

The CRC will begin contract negotiations with the Sponsor. After an agreement is reached, the CRC and the sponsoring institution work together to submit the study proposal to the Ethics Committee. The University Foundation Ethics Committee meets twice a month.

When all regulatory approvals have been obtained, two copies of the Contract Agreement are signed by University Foundation (CRC) and by the industrial sponsor.