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BIOSTATISTICS

Turn data into meaningful strategic information to make informed decisions, improving patient safety, drug efficacy and getting drugs to market faster.

The need for advanced biostatistics services and efficient clinical development strategies to shorten timelines, reduce costs and risks, and improve the quality of submissions is vital for drug approvals. State-of-the-art statistical methods play a key role in every step of the drug development process.

IKCON PHARMA  believe that the most efficient and cost-effective way to conduct and control clinical trials is to make the best possible use of advanced and innovative statistical methodologies. Clinical data should be analyzed and report in a compliant manner and with highest quality for product/drug approvals. Our list of services includes but not limited to:

  • Study Design

  • Adaptive Study Design

  • Statistical Analysis Plan (SAP)

  • Sample Size Calculations

  • Trial Simulations

  • Tables, Listings and Graphs for Clinical Study Reports (CSR)

  • CDISC Standards: mapping STDM into ADaM

  • Integrated Safety & Efficacy Analysis (ISS/ISE/ISM)

  • EndPoints

  • CRF and Database Structure Review for PK/PD Data

  • Meta-Analysis

  • Interim and final biostatistical analysis

  • Fraud Detection

  • Input to CTD Summary Documents