Advice Pharma with ICE eCRF among the sponsors of ePharma Day, May 16, 2018 in Milan
Clinical research 2.0: Strategic, organizational, infrastructural and quality aspects.
The world of clinical research is in a phase of profound transformation. The acceleration of scientific knowledge in recent years is leading to an exponential increase in the number of clinical trials with new drugs. This increase in studies is associated with a profound methodological transformation, which leads to overcoming, thanks to adaptive designs and approaches “basket- and “umbrella trials”, the classic model of development based on sequentially managed phases for individual New Chemical Entities.
In order to ensure rapid access to new drugs for patients and to contain high development costs, the regulatory authorities, FDA and EMA, are willing to accept new approaches ranging from new experimental designs, to early access models, to the management of certain aspects of development with a “risk based” approach, up to the opening of the future use of Real Word Evidence data.
In this context, operators involved in the management of clinical research are faced with major new challenges.
- What is the evolution of skills, processes and tools in pharmaceutical companies, CROs and research centres, also in view of the regulatory changes taking place?
- What organisational changes will we have to face and what are the priority areas?
- How much will the technological evolution affecting the world of health care influence the way clinical research is carried out?
- What is the point of view of doctors, study nurse, research coordinators and data managers who work in this sector and who are experiencing this transformation?
- What is the right balance between complexity, speed and quality to make the Italian system more competitive at European level?
Antonino Amato, Managing Director of Clinical Trial Center SpA, a subsidiary of Fondazione Policlinico Universitario A. Gemelli; Paolo Morelli, CEO of PM Holding; Simona Re, Clinical Operations Therapeutic Area Leader Oncology and Hematology of Roche SpA and Sergio Scaccabarozzi, Head of Clinical Operations of Roche SpA, scientific coordinators of the event, will lead a panel of experts in order to share best practices, results and experiences in this field.