Clinical Trials / Sponsors

Rich in news, the regulations on clinical trials are constantly evolving, in particular with the entry into force of the European regulations on clinical trials of medicinal productsn°536/2014 of 16 April 2014 and on medical devices (MD) n°2017/745 of 5 April 2017, as well as all the associated guidelines and test phases for implementation.

Our ongoing involvement in the clinical trials sector

Thanks to their particular expertise in health authorities and the CPP (Comité de Protection des Personnes), which gives them a constant anchoring in the practice and new issues of the sector, both in terms of medicines and medical devices, ELSI's lawyers intervene on all questions relating to the regulation of clinical trials and assist sponsors and investigators in their dealings with the authorities.

In addition to regulatory aspects, ELSI also deals with liability issues and assists its clients with contractual issues related to clinical trials (mandate contract, single agreement, etc.), as well as with the development of research.

Clinical trial sponsors, Our main areas of intervention

Health data
  • Identification of personal data
  • GDPR compliance
  • Personal data policy
Clinical trial contracts: sponsor / CRO, single agreement support
  • GDPR compliance, DMOS and transparency, best practices...
  • Supporting the sponsor's relationship with investigators, institutions and CROs
Review of information leaflet, clinical trial consent
  • GDPR compliance, ethics, clinical trials regulation
Clinical trial litigation
  • Product liability litigation management
Patient recruitment
  • Compliance of clinical trial sites
  • Support in promoter-investor relations
  • Compliance of procedures
  • Support in defining and determining responsibilities and declarations

The ever-changing regulatory framework for clinical trials and investigations

Following the Jardé Law n° 2012-300 of 5 March 2012 on research involving the human person, and its implementing decrees, the clinical research framework is once again undergoing major changes, encouraged both by the desire to make the sector more attractive in France and by the contributions of new European texts.

First of all, the regulatory framework for research on medicinal products has undergone major upheaval with the entry into force of the European Regulation on clinical trials, which repeals Directive 2001/20/EC on clinical trials and simplifies the procedures for sponsors through the creation of a one-stop European shop, the centralised Internet portal (CTIS ), where clinical trial applications and the publication of results are submitted at a single point in the European Union. The timetables for scientific and ethical evaluation by the ANSM and the CPPs have also been simplified, as have the procedures for intervention by the competent authorities.

While non-interventionalstudies and clinical investigations involving cosmetics and medical devices (MDs) are excluded from this new legal framework, the MD and IVD sector must adapt to the Regulations of 5 April 2017 in terms of both clinical investigations and the newclinical evaluation requirements.

The diversification of the different types of studies and research requested by the health and reimbursement authorities (real-life studies, use of clinical databases and/or the National Health Data System (SNDS), quality of life, patient registers, etc.) and the question of the framework within which they are to be conducted.) and the question of the framework in which they are conducted also drive the issues in this sector.

In this context, the classification and qualification of the types of studies, the processing of personal data and related health data, the methods of collecting these data, recruiting and informing patients, communication, the supply of products, the new requirements of transparency, vigilance, in a constantly evolving context with regard to the field of possibilities, particularly technical, are all questions that any industrialist, CRO, sponsor or investigator must face and for which the assistance of a lawyer specialising in clinical trials may be necessary. This is why our law firm, specialised in health products and clinical trials, assists its clients in the strategy and legal security of all aspects of the life cycle of their products.

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