We operate dedicated delivery pools in Hyderabad and Visakhapatnam with identical skill distribution, ensuring uninterrupted business continuity and risk mitigation.
| Role | Experience | Coverage |
|---|---|---|
| Principal Programmer / Biostatistician | 12–18 yrs | SAP development & review, regulatory strategy, sponsor governance, complex studies |
| Senior Programmer | 7–12 yrs | SDTM/ADaM leadership, reviewer interaction, submission deliverables |
| Stats-II Programmer | 4–7 yrs | Independent ADaM, TLF programming, advanced QC |
| Stats-I Programmer | 2–4 yrs | SDTM mapping, TLF execution, validation support |
Additional Strengths
Backup coverage for all critical roles
Cross-trained therapeutic teams
Rapid ramp-up within 2–4 weeks
Programming & Delivery SOPs
SDTM & ADaM development (CDISC compliant)
TLF programming (Tables, Listings, Figures)
Independent QC & double programming
Standardized programming practices & macro usage
Governance & Compliance SOPs
Change control & version management
Submission lock & handover process
Audit and inspection readiness
Data privacy & access control (21 CFR Part 11)
Our proprietary AI-enabled validation tool enhances quality and accelerates delivery.
Key Capabilities
Automated shell vs output comparison
Population count verification
Statistical method consistency checks
Footnote & formatting validation
Version-to-version comparison
Full audit-trail ready validation logs
Business Impact
40–60% reduction in QC effort
Faster DBL to CSR timelines
Reduced late-stage error risk
✔ Live demo available (30–45 minutes)
Primary Point of Contact
Associate Director – Statistical Programming
14+ years of industry experience
Therapeutic areas: Oncology, CNS, CV, Rare Diseases
Regulatory exposure: FDA, EMA, PMDA
Expertise: SAS, R, Python, CDISC, Automation
Escalation Structure
Study-level leadership
Program-level oversight
Executive steering support
We offer flexible and transparent pricing tailored to your project needs:
Customizable engagement models: Full-Service, Hybrid, or Project-based
Competitive rates aligned with industry standards
Volume and long-term discounts to maximize your investment
Blended rate options for optimal resource utilization
Scalable teams for quick ramp-up and smooth delivery
Clear, predictable billing with no hidden costs