CDISC Registered Solutions Provider
CDISC Certification
BioClinica announced that the company has successfully attained Clinical Data Interchange Standards Consortium (CDISC) Registered Solutions Provider (RCSP) certification. CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards in the area of clinical trials data.
BioClinica was awarded CDISC certification based on their active participation in the CDISC Clinical Data Acquisition Standards Harmonization (CDASH) project team. BioClinica has been involved with the CDASH project since its initial meeting in October 2006, when it was still known as Phoenix Data Systems. The CDASH team released v1.0 of their standard in October, 2008 and is currently getting ready to release v 1.1 and release the v 1.0 of the Clinical Data Acquisition Standards Harmonization (CDASH) User Guide (UG).
Benefits of implementing CDISC standards include: increased data quality, improved data integration, enhanced scalability and re-usability of global case report form and edit check libraries and a more streamlined data exchange process. According to the PhRMA-Gartner-CDISC project, there is a per study cycle time reduction of 8.1 months and a per study cost savings of $9 million, when standards are implemented in the study startup stage. BioClinica offers tools and services to allow our customers to build CDASH compliant electronic case report forms and provides CDISC SAS transformation services such as providing SDTM datasets.
What is the CDISC Registered Service Provider (RSP) program?
As a service for organizations who are looking for assistance in implementing CDISC standards, CDISC has established a program for CDISC Registered Solutions Provider (RSP) who are qualified consultants, system integrators, and subject matter experts believed by CDISC to have sufficient knowledge and experience implementing the various CDISC standards.
This CDISC certification goes to an individual who demonstrates the following and provide the following minimum criteria:
- Adhere to the CDISC Code of Ethics
- Have a positive overall reputation for services in some aspect of clinical research
- Be involved in CDISC as a sponsor, member, benefactor, associate, or active team participant
- Demonstrate expertise in one or more CDISC models, as evidenced in at least one of the following ways:
- Completion of advanced, model-related activities or applications such as controlled testing of CDISC models or demonstrations at events like an End to End demo
- Active participation on a modeling team for a period of at least one year with at least 75% attendance (as determined by team leaders), combined with a relevant and clearly defined service offering resulting from team participation.
Learn more about BioClinica's CDISC certification and implementation process!