Specialist biometrics & clinical data.
End-to-end clinical-data expertise, from study startup through database lock and regulatory submission, audit-ready by design and aligned to global standards.
Capabilities
Clinical Data Management
eCRF design, edit-check programming, data cleaning, medical coding, SAE reconciliation, and database lock across therapeutic areas.
Statistical Programming
SDTM & ADaM dataset creation, TLF generation, Define.xml, reviewer’s guide, and submission packages.
Biostatistics
SAP development, interim & final analysis, clinical-trial statistics aligned to ICH E9 and regulatory standards.
Regulatory & Compliance
ICH GCP E6(R2/R3), GCDMP, 21 CFR Part 11, CDISC, audit readiness and inspection preparation.
EDC & Systems Expertise
Multi-platform EDC experience, system configuration, UAT support, and operational workflow design.
SOP Development
System-agnostic SOPs from eCRF design through data archival, aligned to sponsor & CRO requirements.
Study Startup
- Protocol review
- eCRF design
- Metadata build
- Edit-check programming
Data Collection
- EDC configuration
- UAT & site training
- Query management
- Data-entry oversight
Data Cleaning
- Medical coding
- SAE reconciliation
- Discrepancy resolution
- Blind-review prep
CDISC Standards
- SDTM mapping
- ADaM datasets
- Define.xml
- Reviewer’s guide
DB Lock & Submit
- Lock checklist
- QC & audit trail
- Final reconciliation
- Regulatory package
Trusted by clinical research teams
Praveg provided valuable strategic direction while helping us establish scalable biometrics processes. Their understanding of both operations and technology ecosystems significantly accelerated our setup activities.
The guidance on EDC workflows, role structures, and governance models helped us avoid several costly mistakes during our platform planning phase.
The training sessions bridged the gap between textbook knowledge and industry realities. Participants particularly appreciated the practical examples from live clinical-trial environments.
The Clinical Data Management course content was industry-oriented and extremely relevant for freshers entering the field.
Let’s accelerate together.
Reach out for a discovery conversation, no obligation, just clarity on where structure can unlock speed.