We provide all required documents and conduct clinical trials with trusted partners
Providing the required documents for a clinical trial application including an ethics committee approval for ATMPs, requires detailed understanding of this new class of medicinal products. Mares Ltd. provides the required documents:
Clinical trials require a previous approval by the ethics committee and competent authorities. While the first is responsible for safeguarding the rights and safety of all participants of the study, the latter ensures compliance with the relevant legislation. Multi-national clinical trials in Europe may involve several authorities. We guide sponsors through the European approval process and help them obtain harmonized assessments, avoiding the need for multiple applications.
Since 2009, the EU ATMP regulation (Advanced Therapy Medicinal Product Regulation (EC) No 1394/2007) is in force and regulates the approval of gene-therapy, somatic-cell therapy or tissue-engineered products. This regulation provides a pan-European regulation for gaining market authorization of ATMPs. At the same time, the regulation provides certain incentives (such as reduced fees for scientific advice and additional fee reductions for SMEs) for pharmaceutical companies developing advanced cellular and molecular biotech-therapies.
Mares Ltd. offers full regulatory support during the process of marketing authorization, including the preparation of all the necessary documents for marketing approvals (eCTD dossiers).
Clinical Trials in Advanced Therapy Medicinal Products (ATMPs) present fundamentally new challenges to all participating parties, regulatory authorities, sponsors and, most certainly, to CROs.
A profound understanding of ATMP-specific technology, regulatory requirements, organizational and logistical needs is crucial to design, plan and conduct such trials successfully. Convidia provides the relevant network, necessary knowledge and experience to get these demanding clinical trials designed, conducted and brought to successful conclusion.