Our vast competences built up in the field of clinical research and high level of professionalism enable our HEALTH CARE and LIFE SCIENCES Department, operated by highly qualified resources, to provide specialised Legal and Regulatory Affairs & Quality Assurance Consulting services in relation to all aspects of the development of international clinical studies, offering wide-ranging expertise in a broad area of activities, including:

– Contract Management: Preparation, review and negotiation of contracts, in Europe, with service providers (consultants/experimental centres/clinical research organisations) covering all aspects of medical management functions: clinical, data management, statistics, medical writing, medical communication, drug safety, etc., including coordination and intermediation between inter-company functions and experimental facilities (hospitals, universities and local health authorities), in accordance with legal and financial policy;

– End-to-end regulatory compliance of clinical trials: Quality Assurance (QA);

– Staff training in the regulatory and QA field: targeted refresher courses, regulatory, national and international updates; – Vendor selection.

The Department also provides consultancy services to providers and Pharma, with regard to the legal architecture of Patient Support Programmes (PSP), from project feasibility audits, based on the necessary checks of privacy by design, to regulating relations between the various stakeholders, based on appropriate contractual schemes, to auditing compliance with the applicable regulations.