Biostatistics – COD Research

Pre-Defined Statistical Approach: Our team ensures statistical methods are pre-defined in the protocol to maintain integrity and consistency
Statistical Complexities: Adaptive designs introduce challenges such as balancing adaptation with statistical validity, managing variability, and avoiding biases. These complexities are managed by experts
Multiplicity and Alpha Error: Multiple interim analyses can affect the overall alpha error rate. We make necessary adjustments to control type I error and ensure valid results

Key Considerations for Sample Size Calculation:

Study Design Factors: Assessing all relevant aspects of the study to ensure comprehensive analysis
Patient Burden Reduction: Minimizing patient burden to achieve significant cost savings while maintaining the required statistical power and regulatory compliance
Balancing Risks and Costs: Finding the right balance between the risk of trial failure, costs, and recruitment time to streamline the trial process
Expert Analysis: Leveraging the expertise of COD specialists who evaluate impacting factors, complexities, bio-statistical nuances, and associated risks in proposed statistical possibilities

Interim Analysis and DSMB: Interim analyses and Data Safety Monitoring Board (DSMB) activities are pre-defined in the Statistical Analysis Plan (SAP) to maintain protocol adherence
Blinding Strategy: Ensuring a robust blinding strategy during interim analyses to prevent bias and maintain study credibility
Post-DMC Decisions: Outlining and implementing decisions post-DMC meetings based on predefined criteria for systematic and transparent execution
Pre-Planned Analysis: To support the DSMB quorum in making timely and informed safety decisions, pre-planned analyses are essential. These analyses provide the necessary elements and data, allowing the DSMB to evaluate the trial’s progress and make safety calls effectively

Comprehensive Statistical Analysis Plan (SAP) Preparation: We specialize in creating detailed Statistical Analysis Plans (SAP) to outline the statistical methodologies and procedures to be followed throughout your clinical trial
SAS Programming: Our team of expert SAS programmers meticulously programs and analyses clinical trial data to ensure accuracy and compliance with regulatory standards
TLF Generation: We generate Tables, Listings, and Figures (TLFs) that provide a clear and comprehensive presentation of your clinical trial data, facilitating easy interpretation and decision-making
PK/PD Analysis: Our pharmacokinetic (PK) and pharmacodynamic (PD) analysis services offer in-depth insights into the drug’s behavior within the body and its biological effects, helping to ensure the safety and efficacy of your clinical trials

SDTM (Study Data Tabulation Model): Structured datasets are defined for regulatory submission and review, ensuring clarity and compliance
ADaM (Analysis Data Model): Efficient datasets for accurate statistical analysis, aligned with study needs and supported by detailed Define.xml metadata files for SDTM and ADaM, ensuring transparency and smooth regulatory reviews

Our End-to-End Biostatistics Solutions