FDA has formally accepted CDISC standards as a mechanism for exchanging study data. eCTD specification is accepted as an xml file (Define.xml) specification. Further FDA announced that starting January 1st 2008, eCTD will be the only electronic submission format accepted for NDA, IND, ANDA, BLA submissions. Life sciences companies are rapidly adopting CDISC standards, primarily ODM and SDTM to conform with FDA regulations and to interchange data seamlessly across different clinical trial systems. Adoption of CDISC standards will accelerate the regulatory review process and generate fewer queries. CDISC standards help in early signal detection, due to data mining capabilities using XML structures.
LAXAI offers a range of services to achieve CDISC compliance.
CDISC Strategy, Gap Analysis and Business Case preparation including CDISC compliant tool selection
Customized CDISC Training
SDTM and ODM compliant database design services
Data Integration and Data Mapping services for SDTM compliance
Customized ODM Gateway services for external data integration
Legacy CDM conversion to achieve SDTM compliance
SDTM and ADaM compliant dataset preparation
CRT DDS and Define.xml (eCTD) preparation
Our service offering encompasses both the Data Management and the SAS Programming view of achieving CDISC compliance. LAXAI is a CDISC member and our consultants have a thorough understanding of ODM, LAB, SDTM and ADaM standards.
Engagement Models
LAXAI has experienced CDISC resources both at its offsite center in NJ and offshore center in Hyderabad. Activities such as CDISC strategy & business case, CDISC training and eCTD preparation services are carried out of our offsite solution center, technology related services such as database design services, SDTM mapping & analysis datasets creation and legacy data conversion are offered both at our offsite solution center and offshore solution center in Hyderabad, India.
