Maxer helps sponsors in transitioning to CTIS

Last November, Maxer Consulting team has obtained the EMA CTIS Sponsor Master Trainer certificate, issued by the European Medicines Agency and DRUG INFORMATION ASSOCIATION (DIA) at the end of the course dedicated to the Clinical Trial Information System (CTIS) platform, which has come into force on January 31, 2022. CTIS full operation implements EU Regulation 536 / 2014 on clinical trials of medicinal products for human use, repealing Directive 2001/20 / EC.

CTIS provides for the access of regulatory authorities, commercial and academic sponsors, and the public. In particular, the access of sponsors and the management of the clinical trials life cycle, from registration to publication of results and layperson summaries, requires specific skills and organizational alignment with the standards of competencies indicated by EMA.
Maxer, attending the EMA CTIS Sponsor Master training course and accessing the test environment (CTIS Sandbox) EMA reserved for the CTIS Sponsor Master Trainer participants, is qualified for supporting pharmaceutical companies transitioning to CTIS.

Thanks to the expertise of change management methods previously developed in pharmaceutical companies, the Maxer team can assist sponsors in implementing the communication, training, and organizational alignment actions envisaged in the framework of the User Personas program. EMA has expressly developed User Personas to support the teams involved in the transition phase. Maxer consultants, as CTIS Master Trainers, have the experience and skills required for this activity.