Biostatistics & Clinical Data Management
Biostatistics & Clinical Data Management
Transforming Data into Insights, Powering Research Success
At ADI Backoffice, we turn raw clinical data into meaningful insights that drive smarter decisions, faster approvals, and stronger research outcomes. With precision, compliance, and innovation at our core, we ensure seamless data flow, error-free analysis, and regulatory-ready submissions—helping you bring life-changing therapies to market with confidence.
Unlock Excellence: Data-Driven Solutions for Clinical Success
Biostatistics & SAS Programming – From Numbers to Knowledge
Our expert biostatisticians and SAS programmers deliver powerful analytics and regulatory-compliant datasets that accelerate clinical research.
SAS Programming – Custom programming for data analysis, reporting, and automation.
Macro Production, Validation & Optimization – Developing and optimizing macros for efficiency and accuracy.
Interim Analysis Support – Statistical analysis for ongoing clinical trials to guide decision-making.
CDISC Mapping & Conversion – Structuring data per CDISC (SDTM & ADaM) standards for regulatory submissions.
CDISC Submission-Ready Dataset Development & QC – Preparing high-quality datasets that meet global compliance requirements.
Analysis Datasets & TLFs Development – Creating statistical tables, listings, and figures (TLFs) for clinical study reports.
Define.xml Files for SDTM & ADaM – Generating metadata files required for regulatory submissions.
Submission-Ready Packages – Compiling complete submission packages, including Define.xml, Reviewer’s Guide & Analysis Metadata, ensuring smooth regulatory approval.
Clinical Data Management – Accuracy, Compliance & Control
We ensure that every data point is accurate, validated, and submission-ready, reducing risks and expediting clinical success.
Data Transfer & eCRF Build – Seamless data integration and electronic Case Report Form (eCRF) development.
Annotated CRF & Data Management Plan – Structuring data collection with clear guidelines for consistency and compliance.
Quality Control of Datasets – Ensuring data accuracy, integrity, and completeness before submission.
CRF Design with SDTM Guidelines – Creating standardized CRFs aligned with CDISC SDTM requirements.
Programming & Testing for Data Validation – Implementing robust validation checks for clean, reliable data.
Data Cleaning & Query Management – Identifying and resolving discrepancies for high-quality datasets.
Medical Coding (MedDRA & WHODrug) – Standardizing clinical terms for accurate safety and efficacy reporting.
Lab Data Integration & Patient Diary Management – Consolidating lab results and patient-reported data for comprehensive analysis.
EDC System Implementation & Dictionary Setup – Configuring electronic data capture (EDC) systems and setting up controlled vocabularies.
Final Quality Control & Database Locking – Conducting last-stage quality checks before securely locking the database.
Database Archiving – Storing clinical data securely for future reference and regulatory audits.
Why Choose ADI Backoffice?
Regulatory-Ready Data
Compliance with CDISC, FDA, EMA, and global standards
AI-Driven Accuracy
Cutting-edge data validation and analytics
End-to-End Data Solutions
From trial design to submission-ready reports
Faster, Smarter Approvals
High-quality datasets optimized for seamless regulatory acceptance
