This is a powerful, modern terminology that signals a shift from “data cleaning” to “data intelligence.” Using the term Clinical Data Sciences Management (CDSM) on your website positions Mahat Solutions / SCL IT as a forward-thinking partner that doesn’t just manage data—it extracts value from it.
Here is the tailored content for this specific service section, followed by a custom image generation.
This is a powerful, modern terminology that signals a shift from “data cleaning” to “data intelligence.” Using the term Clinical Data Sciences Management (CDSM) on your website positions Mahat Solutions / SCL IT as a forward-thinking partner that doesn’t just manage data—it extracts value from it.
Here is the tailored content for this specific service section, followed by a custom image generation.
This is the “brain” of the operation. SCL IT provides expert analysis to transform raw clinical data into actionable insights for drug approval.
Key Offerings: Power analysis, Sample size calculation, Randomization plans, and Creation of Statistical Analysis Plans (SAPs).
Software Focus: Advanced SAS Programming for analyzing clinical trial medication effects and side effects.
Electronic Data Capture (EDC): Deployment and management of digital trial databases.
Data Validation: Rigorous cleaning to ensure “regulatory-ready” data.
Medical Coding: Standardizing adverse events and medications using MedDRA and WHODrug.
SDTM Programming: (Study Data Tabulation Model) Organizing data into standard domain structures.
ADaM Programming: (Analysis Data Model) Creating analysis-ready datasets.
Define.xml & Pinnacle 21: Ensuring data packages are 100% compliant for electronic submission.
Clinical Monitoring: Oversight of trial sites to ensure patient safety and data quality.
Medical Writing: Authoring clinical study reports (CSRs), protocols, and investigator brochures.
Pharmacovigilance: Monitoring and reporting drug safety profiles post-market or during trials.
