In today’s regulatory landscape, compliance is not optional—it is the passport to approval. At Mahat Solutions (powered by SCL IT), we specialize in transforming complex clinical data into fully compliant, submission-ready packages that meet the rigorous standards of the FDA (US), EMA (Europe), and PMDA (Japan).
We don’t just “format” data; we ensure its traceability, integrity, and scientific validity from the source to the submission.
In today’s regulatory landscape, compliance is not optional—it is the passport to approval. At Mahat Solutions (powered by SCL IT), we specialize in transforming complex clinical data into fully compliant, submission-ready packages that meet the rigorous standards of the FDA (US), EMA (Europe), and PMDA (Japan).
We don’t just “format” data; we ensure its traceability, integrity, and scientific validity from the source to the submission.
We convert raw data (from EDC, Labs, ePRO) into the industry-standard structure required by regulators.
Mapping & Programming: Precise mapping of raw datasets to standard domains (DM, AE, LB, etc.).
Custom Domains: Expert handling of therapeutic-specific domains (e.g., Oncology, Cardiology).
ACR creation: Annotated Case Report Forms (aCRF) that clearly link data collection to SDTM variables.
While SDTM is for storage, ADaM is for answers. We build analysis-ready datasets that allow statisticians to easily reproduce study results.
Traceability: Ensuring every data point in the analysis can be traced back to its source in SDTM.
BDS & ADSL: Expert creation of Subject-Level (ADSL) and Basic Data Structure (BDS) datasets.
Submission-Ready: Optimized for generating the Tables, Listings, and Figures (TLFs) needed for the Clinical Study Report.
The “map” that regulators use to navigate your data. We ensure it is flawless.
Define.xml Generation: Creating fully compliant XML metadata files (V2.0/V2.1).
cSDRG & nSDRG: Authoring clear Clinical and Non-clinical Study Data Reviewer’s Guides to explain any data nuances to FDA reviewers.
Have older studies that need to be brought up to code? We specialize in legacy data migration, converting old proprietary formats into modern CDISC standards for Integrated Summaries of Safety/Efficacy (ISS/ISE).
