The Workshop

The move towards standardisation in data management during clinical trials is one of the biggest challenges facing manufacturers and CROs today. CDISC standards have evolved over a number of years and are set to shape the future of data management as the industry moves towards a more consistent approach to managing the vast amount of data generated during a trial.

Implementing CDISC standards requires a thorough understanding of the processes involved and how to match these to in house practices to ensure that the complexities of standardisation are managed effectively and the outcomes meet the guidance set out in the range of standards.

This workshop provides a peer to peer interactive environment to engage and discuss the challenges of implementation of core standards. It is intended to enable practitioners to share their experiences with colleagues on how best to move forward in making processes fit the CDISC model as the industry moves rapidly towards a uniform approach to data management.

1. Understand the content of CDASH
2. Learn how to map CDASH into SDTM, including each field existing in CDASH and not in SDTM
3. Learn how to map sponsor CRFs into CDASH with results that are both CDASH and SDTM conforming

Validating the CDISC Study Data Tabulation Model

Introduction to CDASH and compatibility with SDTM

Standardisation as a route to ease the submissions and approval process

Development of the CDISC HL7 messages

Technical Implementation Strategies in a CDISC environment

Operational Data Modelling Implementation

Alessandro Antonellini is a statistician and data manager with experience of drug development from phase I to IV in international projects with several dossier submissions in US and Europe. The major therapeutic areas where the expertise has been developed are immunology, oncology, supportive care, urology and cardiovascular.  In 1987 he obtained the Bachelor in Sciences in Statistics at the Università Cattolica in Milan and in 1989 started working in the pharmaceutical industry. During his professional career he had the opportunity to work in Italy for different companies, big pharma like Sandoz and Pharmacia as well as small biotech like Novuspharma and Cell Therapeutics Europe.  Before joining Recordati S.p.A. as Head of Statistics and Data Management at the beginning of 2009, he worked in Switzerland for Helsinn Healthcare SA.

Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), dedicated to the research, development, manufacturing and marketing of pharmaceuticals, with headquarters in Milan, Italy, operations in the main European countries, and a total staff of over 2,900.

http://www.recordati.com/

Dr. Zhang has worked in Pharmaceutical and Biotechnology Industries for over13 years. She is an active member of HL7 and CDISC standard organizations. Her expertise is in following areas:

1. regulatory submissions both in paper and electronic
2. development/implement industry standards (HL7, CDISC) for submission, statistical analysis reporting and clinical trial data collection
3. statistical analysis on clinical trial
4. data management, such as clinical data collection, reviewing, cleaning, and exchange, etc.
5. Clinical trial database design.  Her broad clinical experiences cross different therapeutic areas including infectious diseases, respiratory, oncology and rare inherited disorders.