Biostatistics Services
- cGCDMP
- 21 CFR Part 11
- CDISC/CDASH
- SDTM
- ADaM
- HIPPA
- Global Regulatory Guidelines
Our team of biostatistician and statistical programmers provide a full range of biostatistical services including sample size calculations, randomization schedule generation, blinding and unblinding procedures, statistical analysis plans and statistical analyses.
Biostatistics Services
- Clinical Trial Study Design
- Study Sample Size Calculations and Randomization
- Statistical Inputs to Clinical Study Protocol Development
- Statistical Analysis Plan (SAP) Development and Interpretation
- Statistical Reports
Statistical Programming
- SAS Programming as per CDISC (SDTM/ADaM) Standards
- Performance of Statistical Analysis
- Generation of Tables/Listings/Graphs (TLGs) and Validation
- Generation of Tables/Listings/Figures (TLFs) and Validation
- Performance of interim Statistical Analysis
- Stand-alone Statistical Reports
- Clinical Statistical and Study Reports Writing
- SAS Datasets Creation as per CDISC
- Program Validation
- Integration of Databases Across Protocols
- Integrated Summaries of Safety and Efficacy (ISS & ISE) for Regulatory Submissions.
- Summary of Clinical Safety and Efficacy (SCS & SCE) for Regulatory Submissions.
- Data derivation and mapping to CDISC standards
- Implementation of CDISC SDTM and ADaM standards
Clinical Biostatistics Services in India
Innovate Research stands as a leading biostatistics and statistical analysis CRO partner in India, trusted by pharmaceutical, biotechnology, and medical device companies for rigorous, science-driven statistical solutions. Our clinical biostatistics services support both local and international trials by combining Indian regulatory expertise with deep global experience. Sponsors depend on us for efficient, compliant, and insightful biostatistical analysis that accelerates their drug and device development pipelines.
End-to-End Biostatistics and Statistical Analysis CRO Support
As one of India’s foremost biostatistics CROs, Innovate Research offers comprehensive support at every stage of your clinical program. Our services span Phase I–IV clinical trials and include:
- Protocol and Study Design Consultation: Crafting scientifically sound trial protocols that maximize efficiency and reduce bias.
- Sample Size Calculation & Randomization: Ensuring each study is statistically robust and recruitment is optimized.
- Interim & Final Analysis: Delivering rapid, reliable insights aligned with global standards for adaptive and traditional trial designs.
- Regulatory Submission Support: Preparing precise statistical reports and outputs for authorities including CDSCO, FDA, EMA, and more.
- Compliance: Our compliance with ICH-GCP, Indian CDSCO, FDA, and EMA means your clinical trial statistical analysis stands up to international scrutiny and local regulations.
Our Biostatistics Process in Clinical Trials
At Innovate Research, our systematic approach to biostatistics services in clinical trials ensures meticulous planning, execution, and reporting. Our processes include:
- Study Design & Protocol Development: Tailoring strategies to each indication and regulatory landscape; building a strong scientific foundation from the outset.
- Sample Size & Power Estimation: Using statistical modeling to ensure each Indian and multinational study is powered for success.
- Randomization & Blinding Techniques: Reducing trial bias through robust, transparent methods for patient allocation and outcome assessment.
- Interim & Final Analysis: Enabling adaptive trial designs, rapid study decisions, and protocol adjustments with minimal delay.
- Regulatory-Compliant Statistical Reports: Generating submission-ready tables, listings, and figures for CDSCO, FDA, EMA, and other agencies.
Every clinical trial statistical analysis in India is performed by our skilled team using validated software (SAS, R) and compliance with global data standards (CDISC, SDTM, ADaM).
Why Choose Innovate Research as Your Biostatistics CRO Partner in India?
Choosing Innovate Research means working with a biostatistics CRO partner known for its commitment to both scientific integrity and operational agility:
- Local Expertise, Global Horizons: Deep knowledge of Indian CDSCO frameworks, plus international regulatory standards.
- Expert Biostatistics Team: Indian and global statisticians and programmers with experience in diverse therapeutic areas.
- Seamless Research Integration: Close coordination with our clinical data management and medical writing teams for smooth study operations.
- Proven Track Record: Successful trial analyses and accelerated timelines for both Indian and multinational sponsor studies.
- Flexible Solutions: Tailored biostatistics support for pharma, CROs, academia, and device companies; no study is too complex or too simple.
Our commitment to compliance, precision, and strategic guidance sets us apart, making Innovate Research the first choice for clinical biostatistics services in India. Advance your program with Innovate Research – India’s leading biostatistics and statistical analysis CRO for clinical trial excellence.
FAQs About Clinical Biostatistics Services
Clinical biostatistics services involve expert data analysis, trial design, sample size management, and statistical reporting to support all clinical study phases and regulatory submissions.
Biostatistics ensures that research is scientifically valid, interpretable, and regulatory compliant through rigorous study planning, randomization, statistical modeling, and outcome interpretation.
Innovate Research follows international and Indian regulatory standards, uses state-of-the-art statistical software, and enforces thorough quality checks at every analysis step.
Yes, our team prepares and formats all statistical deliverables to meet CDSCO and international requirements, for seamless multi-region submissions.
Absolutely. We offer biostatistics services for post-approval studies, safety surveillance, and long-term follow-up analyses.