"Shafi Consultancy did some very complex and important data transformations for us for high profile multiple trials..."
F. Hoffmann-La Roche
"Shafi Consultancy analysed a very large and complex database for us... "
"...responding to FDA questions at short notice under extremely short timelines, Shafi Consultancy has helped our client ... meet all their timelines..."
"Shafi Consultancy supported us with essential data transformations and analyses that ensured we met our project timelines...."
"Shafi ran a bespoke SAS training session for a small group of us to...."
CDISC format data
Clinical Data Interchange Standards Consortium (CDISC) is an open, multidisciplinary, neutral, non-profit standards developing organization, which has been working to develop global standards and innovations to streamline medical research.
Submissions of New Drug Applications (NDAs) to the FDA now require companies to submit clinical study data according to the CDISC standards. Japan (PMDA) and EMA have also stated that they will accept data according to CDISC standards.
Shafi Consultancy provides a number of expert CDISC services and personalized solutions, including:
- CDISC data conversion from legacy data – SDTM and ADaM.
- Implementation of CDISC standards in the sponsor’s environment.
- Generation of define.xml.
- Tables, Listings and Figures based on SDTM and ADaM data structures, including standard macros.