Streamlining Data Integrity: Validity, Reliability, and Interpretability in Clinical Trials

We deliver clinical biostatistics services that strengthen the integrity and reliability of clinical trial data. Our expert team specializes in biostatistics and statistical analysis in clinical trials, ensuring accuracy, compliance, and scientific rigor across every stage of development.

Our End-to-End Biostatistics Solutions

Clinical Design

Special approaches like Adaptive Design
  • 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
Sample Size Calculations

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

Our Expert Biostatistics Team

Our team consists of experts in electronic data capture (EDC) technology and patient-reported outcomes (PROs).. With proficiency in biostatistics in clinical trials and trusted biostatistics CRO services, we provide tailored solutions that help biotech and pharma clients achieve trial success with efficiency and compliance.

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Study Builder

Has a deep understanding of EDC workflows and can seamlessly integrate e-PRO solutions

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Project Leader

Acts as the central point of contact for all EDC-related activities throughout the clinical trial lifecycle

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Randomization Manager

Serves as an independent member of the team with oversight of all randomization activities, ensuring the integrity of randomization processes in clinical trials

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SDTM Experts

Oversee and streamline all SDTM programming activities, including regulatory monitoring, team training, interaction with sponsor counterparts, and tool maintenance, ensuring reliable data and precise statistical analysis.

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SAS Programmers

Our specialists in SAS programming in clinical trials meticulously program SDTM databases and deliver outputs such as patient profiles, data listings, and define.xml files. Their SAS expertise ensures compliant and efficient deliverables for reliable trial outcomes.

Request for Proposal

Choose COD Research for expert clinical biostatistics services and proven biostatistics CRO services. With deep expertise in statistical analysis, SAS programming in clinical trials, and SDTM programming, we ensure compliant, accurate, and efficient trial outcomes. Contact us today!