Comprehensive CDISC Mapping and Submission Solutions
As your partner, we'll leverage our indication-specific knowledge to guide you through the full data mapping process, including:
- Twenty-plus years of Data Mapping & Standardisation
- Experts in CDASH, SDTM & ADaM
- Highly experienced programming team with statistical knowledge and expertise to increase efficiency and transparency
Expert CDISC Solutions from Raw Data to Submission
Standardizing data into CDISC format is a difficult and time-consuming task requiring expert skills and specialist experience to ensure your study meets all the requirements for submission.
Due to updated rulings from the FDA/PMDA, there is now, more requirement than ever to submit data in CDISC format. For the FDA, any study that started on or after December 2016 requires CDISC standardized data. Similarly, a newer ruling for the PMDA has also come into effect for submissions after April 1st 2020.
Our dedicated team of CDISC specialists with combined experience in SDTM, ADaM and associated documentation so no need for separate teams for standardization or analysis. They work across all CDISC standards and have supported many clients with submission efforts to regulatory authorities.
Why choose Alira Health?
The CROS NT and Alira Health biometrics team has provided expert statistical guidance for over 500 projects, including regulatory communication and submissions, study-based data management, biostatistics, and statistical programming. You will benefit from our:
- Exceptional customer service and site relations
- In-depth expertise across the entire clinical trial process
- Flexible and tailored service delivered by multidisciplinary and global teams
- Frequent, transparent, and professional communication
- Guarantee we will lead your study efficiently, safely, and successfully