At CLINZTECH, our SAS Programming Services offer scalable, flexible, and high-quality statistical support tailored for the biopharmaceutical and clinical research industries. With a strong presence in India, our team consists of highly qualified SAS programmers and biostatisticians who contribute to all phases of clinical development—ensuring data integrity, compliance, and strategic insight throughout your trial’s lifecycle.

Whether you’re looking for end-to-end clinical statistical support or assistance with a specific part of your study, CLINZTECH is your trusted partner. We provide integrated statistical and programming solutions that are regulatory-compliant, quality-assured, and tailored to your exact specifications.

Core Capabilities and Services

Biostatistics Services

Our biostatistics team ensures scientifically sound design and statistically robust interpretation of clinical data. With extensive therapeutic area knowledge and regulatory experience, we help you make informed, data-driven decisions.

Key services include:

• Protocol Development Support: Guidance in the development of protocol sections relevant to statistical methodology.
• Sample Size Calculation and Power Analysis: Determining the optimal number of subjects to ensure study objectives are met.
• Statistical Analysis Plan (SAP) Development: Preparation of comprehensive SAPs based on study endpoints, data characteristics, and regulatory guidelines.
• Randomization Planning and Implementation: Creating reproducible randomization schedules, including stratified and block designs.
• Interim and Final Data Analysis: Conducting primary, secondary, safety, and exploratory analyses.
• Integrated Summary of Efficacy (ISE) and Safety (ISS): Analysis and preparation of integrated datasets for regulatory submissions.
• Support for DSMBs and Regulatory Meetings: Providing statistical documentation and responses for FDA, EMA, and other agencies.
• Post Hoc and Exploratory Analyses: Data mining, subgroup analysis, and predictive modeling to extract deeper insights.

SAS Programming Services

Our SAS programmers are proficient in producing submission-ready datasets and reports. We ensure traceability, transparency, and quality at every step.

Our programming capabilities include:

• CDISC-Compliant Dataset Development: Creation of SDTM and ADaM datasets adhering to CDISC, FDA, and other regulatory standards.
• Table, Listing, and Figure (TLF) Generation: Development of high-quality outputs for clinical study reports (CSRs).
• Data Validation and Reconciliation: Ensuring consistency across datasets, sources, and third-party data.
• Automated QA and QC Programming: Dual programming and automated QC to maintain the highest standards of accuracy.
• ISS/ISE Programming Support: Preparation of integrated datasets and outputs for NDA/BLA/MAA submissions.
• Efficacy and Safety Reporting: Programming outputs aligned with study endpoints and regulatory expectations.
• Submission Package Preparation: Creation of define.xml, reviewer’s guides, and annotated CRFs in line with FDA eCTD requirements.
• Legacy Data Conversion: Converting legacy datasets to CDISC-compliant formats for submission or re-analysis.

Operational Advantages

• End-to-End or Modular Support: Engage us for full-study support or as-needed statistical and programming services.
• Confidentiality and Data Security: Robust protocols to protect sensitive clinical data.
• Regulatory Familiarity: Our teams are well-versed in ICH-GCP, FDA, EMA, and PMDA requirements.
• Tool & Technology Proficiency: In-depth experience with SAS Base, SAS/STAT, SAS/GRAPH, SAS Macro, and advanced EDC integration.
• Quality-Centric Delivery: QA and QC processes are integrated into every stage of our workflow, ensuring audit-ready outputs.

Why Choose CLINZTECH for Statistical and SAS Services?

• ✅ Experienced Professionals: All statisticians and SAS programmers are qualified, certified, and experienced in global clinical trials.
• ✅ CDISC and Regulatory Compliance: Consistently delivering standards-compliant datasets and documentation for global health authorities.
• ✅ Scalable Solutions: From early-phase studies to multinational Phase III trials, we adapt to meet the scope and complexity of your project.
• ✅ Collaborative Approach: Transparent communication and coordination with your internal teams or external vendors.
• ✅ Cost-Effective Excellence: High-quality service at competitive pricing, ensuring value and efficiency without compromise.

Partner with CLINZTECH for trusted, insightful, and regulatory-aligned SAS programming and biostatistics services that drive clinical success from protocol to submission.