SCDM 2017 Annual Conference Summary
This year’s annual conference for the SCDM took place in Orlando. The venue was fortunately spared the forces of Hurricane Irma. Hurricane Maria had also threatened the area for the opening ceremony, but veered off into the Atlantic and left us to enjoy a very full programme of oral and poster presentations, panel and round table discussions and exhibitions.
The keynote presentation gave an insight into the FDA’s perspectives on clinical trials conducted outside the U.S. The talk discussed how European guidelines and directives and the GCP requirements for validation of data obtained through onsite inspections to assure data quality, integrity, and development of medical products were evaluated from an FDA perspective. The SCDM are actively widening their presence outside the US and, together with presentations of this nature, will undoubtedly bring a wider appreciation and understanding of managing international clinical trials to their predominantly US based membership.
The discussions and presentations were around the hot topics of risk based monitoring, ePRO and CDASH; with CDASH 2.0 being released on the penultimate day of the conference, 25 September 2017. This release updates all previously published domains and adds several new domains that are aligned with SDTMIG v3.2. Implementation of the standards allows up to 67% mapping to SDTM. It was extremely interesting to hear how companies are approaching CDASH and the amount of work and input from CDASH users involved in compiling this latest release. The consortium is now much better placed to align releases of both sets of standards, rather than just playing catch up with SDTM.
This was PHASTAR first foray to the SCDM conference and we were greeted with great enthusiasm and interest. There were over 600 attendees from all walks of the Pharma and CRO industries. Our booth in the Exhibition Hall was well frequented, with plenty of discussion about theapproach to biostatistics, with particular interest in PHASTAR’s capacity and experience working across the continents, North America, Australia, Africa and Europe. To build on these new relationships, PHASTAR has taken up the invitation to join the SCDM’s Europe Committee, which will not only give us the opportunity to play our part by contributing to the initiatives of the SCDM by sharing our knowledge and experience of best practices across multi-national studies but to be part of a dynamic organisation dedicated to the development, support and advancement of Clinical Data Management professionals across the globe.