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BIOSTATISTICS



Biostatistics plays a very critical role in a Clinical Development Program and aims to answer fundamental questions in any clinical trial. 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. Biostatistics Services also extend to generation of randomization schedules, development of robust statistical methodologies, data analysis and generation of study reports. Our Team is well acquainted with distinct statistical challenges in a broad range of therapeutic areas including Pharmacokinetic (PK) and Pharmacodynamic (PD) analyses.


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 (software including SAS®, and Phoenix WinNonlin®)

Our Team provides the following range of Statistical Services:


  • Statistical consulting for Clinical Development Program and study designs

  • Development of statistical sections of the Clinical Study Protocol

  • Sample Size/Power calculations

  • Generation of Randomization Schedule

  • Development of Statistical Analysis Plan (SAP)

  • SAS programming and validation

  • Statistical analysis (interim for futility / efficacy and/or final)

  • Predictive Models, Regression Analysis, Bayesian Statistics, Similarity Measures within clinical cases

  • Generation and validation of Tables, Listings, and Graphs (TLGs) ensuring data output compliance with regulatory standards

  • Statistical outputs for Safety Update Reports and DSMB reviews

  • Interim / Final Statistical Analysis Report

  • PK / PD Analysis using Non-linear Models and Non-linear Mixed Effect Modelling

  • Integrated Summaries of Safety and Efficacy (ISS/ISE) to support regulatory approval

  • 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

  • Response to statistical queries by regulators

 

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