Chiltern International Limited (Chiltern), a global contract research organization (CRO) has earned a Gold Membership in CDISC, the Clinical Data Interchange Standards Consortium.
CDISC is a global non-profit organization that has established standards to support the acquisition, exchange, submission, and archive of clinical research data. CDISC is comprised of nearly 200 global organizations including leading Biotech and Pharmaceutical companies, CROs, and academic institutions. Their mission is to develop and support global data standards that enable information exchange to improve medical research with a vision toward patient care and safety.
Prior to joining, Chiltern has been following CDISC standards with experience in reporting over 100 studies using the SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) models. Now as a member of CDISC, Chiltern will collaborate with global leaders and contribute toward the development and release of new standards. "Membership in CDISC will further enhance our capabilities in delivering quality data and outputs. It signals a commitment by Chiltern to stay out in front of the needs of our clients," explained Michael Wisniewski, Chiltern's Senior Executive Director of Biometrics.
Matthew Juler, Chiltern's Manager of Statistical Programming, Europe added: "Chiltern has been producing CDISC compliant data for a number of years, and by attaining Gold membership we look forward to becoming actively involved in the evolution of the CDISC standards. Our membership will ensure that we are able to implement the latest standards as they come online and continue to provide a high quality product for our sponsors."