Contact Us

Biostatistics

Driving Data-Backed Clinical Decisions

Biostatistics in clinical research plays a central role shaping study design, guiding analysis, and enabling accurate interpretation of trial outcomes. At DiagnoSearch, Biostatisticians come with a rich experience in Statistical Consulting and offer effective solutions towards study design, selection of endpoints, defining hypotheses, sample size justification and power calculations across Phase 1 – Phase 4 clinical trials.

Our Team also comes with an in-depth knowledge and experience in regulatory requirements for study designs in various therapeutic areas and regularly participates in regulatory discussions. The Team plays a pivotal role in project risk assessment and analysis by applying statistical concepts such as Bayesian statistics, hazard scores etc. Our Biostatisticians are accomplished in delivering CDISC and SDTM compliant datasets and are supported by experienced SAS programmers who are conversant with the latest statistical methodologies and technologies.

Our Capabilities

Study Design & Planning

  • Statistical consulting for clinical development programs
  • Sample size estimation and power calculations
  • Development of statistical sections for study protocols
  • Generation of randomization schedules and unblinding codes

Statistical Analysis & Reporting

  • Development of Statistical Analysis Plan (SAP)
  • SAS programming and validation
  • Interim /and final statistical analyses and report
  • Integrated Summaries of Safety and Efficacy (ISS/ISE) to support regulatory approval
  • Statistical analysis (interim for futility / efficacy and/or final)

Regulatory & Advanced Analytics

  • PK / PD Analysis using Non-linear Models and Non-linear Mixed Effect Modelling
  • Predictive models, regression analysis, bayesian statistics, similarity measures within clinical cases
  • Statistical outputs for Safety Update Reports and DSMB reviews
  • Inputs on clinical study documents (CRF, Edit Check Specifications, Clinical Study Reports, Safety Update Reports, DSMB Reports, etc)
  • Performance of Systematic Reviews and Meta-Analysis
  • Participation in regulatory discussions
  • Generation and validation of Tables, Listings, and Graphs (TLGs) ensuring data output compliance with regulatory standards
  • Response to statistical queries by regulators
Biostatistics

Collaborative, Regulatory-Ready Execution

DiagnoSearch’s biostatisticians work closely with Medical, Clinical Operations, and Clinical Data Management teams to ensure precision, compliance, and consistency across all study deliverables. This integrated approach supports reliable analyses, audit-ready outputs, and smooth regulatory interactions.

The DiagnoSearch Advantage

Why partner with DiagnoSearch for Biostatistical solutions

  • Proven Biostatistics and Programming Services across phases and therapeutic areas
  • Strong integration with Clinical Data Management and Clinical Operations
  • Regulatory-ready outputs aligned with global expectations
  • Advanced clinical data analytics solutions supporting timely, confident decisions
  • Experienced teams delivering clarity in complex study environments

DiagnoSearch delivers biostatistics in clinical trials that balances scientific rigor helping sponsors advance programs with confidence.

Connect with DiagnoSearch to explore
how we can support your next study.

Get In Touch