Our Mission
We provide smart, innovative, and cost-effective statistical and clinical programming solutions that help sponsors conduct clinical trials with integrity, transparency, speed, and the highest quality.
We accomplish this through collaborative and synergistic partnerships built on the fundamentals of integrity, proactivity, and transparency. Every deliverable reflects our commitment to regulatory compliance, data quality, and your trial's success.
Our Vision
Our ultimate goal is to contribute to the development of innovative therapies for a wide range of medical conditions—ultimately improving quality of life for patients worldwide.
We believe that reliable, regulatory-ready data and expert clinical programming accelerate therapy development. By partnering with VClinical Biostats, you're investing in solutions that bring life-changing treatments to patients faster.
Why Choose VClinical Biostats
We're not just another CRO. Here's what sets us apart from the competition.
Austin-Based CDISC Expertise
Deep specialization in clinical SAS programming and CDISC standardization (SDTM, ADaM, Define.xml) with a proven track record across regulatory submissions.
Global Delivery, Local Quality
US-based oversight combined with India operations center delivers cost-effectiveness without compromising quality, compliance, or security.
Integrated Service Scope
Not siloed. We handle programming, data management, regulatory affairs, safety/pharmacovigilance, and project management under one roof.
Phase I–IV Trial Expertise
Proven experience across all trial phases and therapeutic areas—oncology, autoimmune, rare disease, neurology, immunology, and more.
Data Quality & Security First
FDA-ready datasets, CDISC compliance, Pinnacle 21 validation, and rigorous data security protocols ensure regulatory confidence from day one.
What This Means for Your Trial
Faster Submissions
Regulatory-ready deliverables mean fewer revision cycles and accelerated FDA review timelines.
Lower Total Cost
Global delivery model reduces per-hour costs by 40–60% without sacrificing expertise or quality standards.
Single Point of Contact
One vendor for programming, data management, and regulatory support—simplified coordination and accountability.
Our Team
A dedicated group of clinical experts committed to delivering regulatory-ready datasets and statistical solutions that accelerate your trials.
Team Size & Expertise
Our 10-member team brings deep clinical trial expertise with an average of 3+ years of end-to-end clinical SAS programming experience per team member. Each member contributes specialized knowledge across regulatory standards, statistical analysis, and study coordination.
Core Competencies
- CDISC Standardization: SDTM, ADaM, and Define.xml expertise
- Clinical SAS Programming: Data mapping, statistical analysis, and macro development
- Regulatory Affairs: FDA submission readiness and compliance expertise
- Project Management: Study coordination, timeline management, and resource planning
Continuous Learning
Our team is committed to staying current with evolving regulatory standards, FDA guidance, and CDISC best practices through ongoing professional development and training.
How We Work Together
VClinical Biostats operates as a synergistic team, with each member contributing their specialized expertise to deliver comprehensive solutions. We collaborate across projects to ensure consistency, quality, and regulatory compliance—while maintaining transparent communication with our partners every step of the way.
Precision-Focused
Every deliverable meets exact regulatory requirements and quality standards.
Compliance-Ready
FDA and CDISC compliance is built into every process and output.
Transparent Communication
Regular updates, clear status reporting, and collaborative problem-solving.
Global Reach, Local Expertise
Strategic locations across the US and India deliver regulatory-ready solutions at competitive costs without compromising quality or compliance.
Austin, Texas Headquarters
US-based quality oversight, client-facing coordination, and regulatory compliance. Our Austin team manages all sponsor relationships and ensures every deliverable meets FDA and CDISC standards before handoff.
13809 Research Boulevard Suite 500
Austin, TX 78750, USA
+1 737-259-8990
India Operations Center
Cost-effective delivery powered by a skilled, experienced workforce. Our India team executes clinical SAS programming, SDTM/ADaM mapping, and data standardization under US-based oversight and quality assurance protocols.
Hyderabad, India
+91 9398497194
The Advantage
- Cost advantage through optimized global delivery
- Speed without quality compromise
- Quality consistency across all operations
- 24/7 potential coverage across time zones
- Regulatory compliance maintained globally
Secure Data Handling Across International Operations
All data transfers between Austin and India follow strict security protocols, encryption standards, and regulatory compliance requirements. Your clinical data is protected regardless of location.