A Clinical Trial is a study on humans designed to discover or verify the clinical, pharmacological and pharmacodynamic effects and safety of one or more medicinal products, medical devices or diagnostic/ therapeutic procedures and techniques, in order to identify the benefits and possible adverse reactions.
The authorization procedure for the initiation of a clinical trial on medicinal products involves the assessment by the Competent Authority and Ethics Committees involved of all documentation relating to clinical trials that are to be conducted. In particular the Clinical Protocol, the IMPD, the informed consent and documentation for patients, the insurance policy (Ministerial Decree of 14 July 2009), manufacturing site authorizations and agreements with clinical sites are all carefully assessed in order to provide public assurance regarding the feasibility and the scientific and ethical aspects of the clinical trial.
A particularly important role in the management of internal processes is held by the National Observatory on Clinical Trials (OsSC), coordinated and managed directly by the AIFA that, in addition to collecting information on clinical trials (phase I-IV) held in Italy since 2000, is a fundamental instrument for managing and monitoring the trials.
The European Commission has recently developed the “Proposal for a Regulation of the European Parliament and of the Council concerning the clinical trials on medicinal products for human use, which repeals Directive 2001/20/EC. ” In recent months, the text is currently under plenary review by the regulatory authorities of the Member States and aims, amongst other things, to render Europe more receptive to a greater number of trials, building a coordination structure capable of responding rapidly to the demands of the “sponsor”.
Di Renzo Regulatory Affairs has set up an expert unit in the area of clinical trials of medicinal products and medical devices consisting of a doctor and highly qualified technicians.
In the field of clinical trials, currently in rapid evolution from a regulatory standpoint, Di Renzo Regulatory Affairs is able to provide regulatory and technical assistance for:
- Interventional and observational Clinical Trials
- Review of documentation to be submitted to the competent authority and the Ethics Committees
- Data entry into the OsSC and the National Register for Observational Studies
- Translation of the dossier, clinical protocols, informed consent and other documents to be included in the CTA.