Training program on Clinical Trial Information System
The new European platform Clinical Trials Information System, which will come into force by January 31, 2022, will require additional skills to register clinical studies and their life cycle management. In this regard, Maxer Consulting has participated in the recent SME and academia Clinical Trials Information System seminar. Thanks to the involvement of EMA, it has also been selected to participate in the Master Training Program dedicated to the new European platform, scheduled between July and October 2021. This last course includes nine half-day meetings, which will cover the following topics:
- Essentials for the CTIS user for sponsors
- Applying, managing, and reporting a clinical trial
- Basics of Training Design, Training Delivery, and Facilitation
Based on this content, Maxer Consulting will develop a tailor-made program dedicated to commercial and non-commercial sponsors.
According to European legislation, the Clinical Trial Disclosure, Data Transparency (CTD & DT), and the Layperson Summaries are mandatory procedures, while only CTD is compulsory, according to the American laws. The obligation to comply with these rules represents a response to the growing demand for transparency from health authorities and public opinion about the efficacy and tolerability of drugs.
Maxer Consulting is the only Italian company able to offer a complete and integrated service on issues related to CTD & DT, having developed over the years in-depth experience and regulatory, regulatory, and technological skills on this matter.