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Biostatistics & Statistical Programming

At VAICS, we offer advanced Biostatistics services that play a crucial role in the design, execution, and interpretation of clinical trials and research studies. Our team of expert biostatisticians utilizes sophisticated statistical techniques and technologies to ensure the accuracy, integrity, and regulatory compliance of your research data.

Our key services

Comprehensive Biostatistics & Statistical Programming services for businesses.

Study design and protocol development

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Data collection and randomization

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Statistical analysis and modeling

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Regulatory and submission support

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Why choose VAICS for biostatistics?

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Study programming specifications

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Content of source submission (SDTM) package

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Content of analysis submission package (ADaM)

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TFL
programming
for businesses

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ISS/ISE submission support

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Data monitoring
committee

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Data
conversions

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BIOSTATISTICS

At VAICS, we offer advanced Biostatistics services that play a crucial role in the design, execution, and interpretation of clinical trials and research studies. Our team of expert biostatisticians utilizes sophisticated statistical techniques and technologies to ensure the accuracy, integrity, and regulatory compliance of your research data.

Study design and protocol development

Inputs to Protocol, Study Design, Statistical Sections, and Study Endpoints :

Protocol development

We collaborate with clients to draft and refine study protocols, incorporating statistical inputs that align with research objectives and regulatory standards. This involves outlining study goals, designing experimental procedures, and specifying statistical methods.

Study design

Our expertise extends to crafting study designs that maximize research efficiency and accuracy. We help define the study population, determine the structure and phases of the study, and select appropriate methodologies such as randomized controlled trials, observational studies, or cross-sectional studies.

Statistical sections

We develop the statistical sections of the protocol, detailing the methodologies for data collection and analysis. This includes specifying the types of statistical tests to be used, handling of outliers, and approaches for managing missing data.

Study endpoints

Defining clear, measurable endpoints is essential for assessing study outcomes. We assist in identifying and articulating primary and secondary endpoints, ensuring they are aligned with the study’s objectives and can be effectively measured and analysed.

Comprehensive SAP creation

The Statistical Analysis Plan (SAP) is a detailed document that guides the analysis of study data. We develop SAPs that outline the statistical methods, procedures for handling data, and the approach for interpreting results. This includes specifying how to handle missing data, define statistical significance, and report results.

Data collection and randomization

CRF design expertise

We contribute to the design of Case Report Forms (CRFs), which are used to collect data from study participants. This involves specifying data fields, designing the layout of forms, and ensuring that all required information is captured accurately. Our goal is to create CRFs that facilitate efficient data collection and minimize errors.

 

Randomization process

Randomization is crucial for eliminating bias in clinical trials. We generate randomization lists that ensure participants are allocated to different study groups in a random and unbiased manner. This involves using statistical algorithms and randomization techniques to create lists that are both valid and reliable.

Statistical analysis and modeling

Power and sample size analysis

Determining the appropriate sample size is vital for the validity of a study. We perform power and sample size calculations based on the study design, expected effect sizes, and desired statistical power. This ensures that the study has sufficient participants to detect meaningful differences and achieve reliable results.

DMC/DSMB support

Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs) play a critical role in overseeing the safety and efficacy of ongoing studies. We support these committees by providing detailed statistical analyses of interim data, helping to assess the safety profile and efficacy of the treatment being tested.

Interim analysis

Interim analyses are conducted at predefined points during the study to evaluate progress and make decisions about continuing or modifying the study. We provide expertise in conducting these analyses, ensuring that the results are accurately interpreted and used to guide study decisions.

Regulatory and submission support

Integrated summary of safety

The ISS provides a comprehensive summary of safety data collected during clinical trials. We assist in preparing this summary by compiling and analyzing adverse event data, evaluating safety trends, and ensuring that the summary meets regulatory requirements.

Integrated summary of efficacy

The ISE summarizes efficacy data from clinical trials, demonstrating the effectiveness of the intervention being studied. We support the development of the ISE by analyzing efficacy data, compiling results across studies, and preparing documentation for regulatory submissions.

Why choose VAICS for biostatistics?

Expert team

Our biostatistics team comprises of highly skilled professionals with extensive experience in clinical trial design and statistical analysis. We bring a depth of knowledge and expertise to every project, ensuring precise and reliable results.

Tailored solutions

We offer customized biostatistical services that are specifically designed to meet the unique needs of each study. Our approach ensures that our solutions are aligned with your research objectives and enhance the overall effectiveness of your study.

Commitment to excellence

We are committed to maintaining the highest standards of statistical rigor and regulatory compliance. Our dedication to excellence ensures that our biostatistical services contribute effectively to the success of your clinical trials and research projects.

STATISTICAL PROGRAMMING

At VAICS, our Statistical Programming services are designed to support the end-to-end needs of clinical trials, ensuring compliance with regulatory requirements and facilitating the efficient submission of clinical data. We specialize in the development and implementation of robust programming solutions that adhere to CDISC standards, including SDTM and ADaM, to provide high-quality, submission-ready datasets.

Creation of study programming specifications

We develop comprehensive programming specifications that guide the creation of datasets, tables, listings, and figures (TFLs). These specifications are crafted to ensure consistency, accuracy, and adherence to the study protocol and statistical analysis plan (SAP).

Content of source submission (SDTM) package

Content of source submission (SDTM) package

Our team creates Study Data Tabulation Model (SDTM) datasets that standardize data across clinical trials, facilitating easier integration and analysis. We ensure that the SDTM datasets are fully compliant with CDISC standards, making the regulatory submission process smoother and more efficient. Key Deliverables: Development and validation of SDTM datasets to ensure standardization and compliance. Creation of Define.xml files to describe the content and structure of datasets. Preparation of annotated Case Report Forms (CRFs) linking the data collection points to the SDTM domains.

Content of analysis submission package (ADaM)

Analysis data model (ADaM) submission package

We generate Analysis Data Model (ADaM) datasets that are specifically designed to support the statistical analysis needs of clinical trials. Our ADaM datasets enable clear traceability from raw data through to the final analysis results, ensuring transparency and reproducibility.

Key Deliverables:

  • Development and validation of ADaM datasets to ensure accuracy and compliance.
  • Creation of Define.xml files and other necessary documentation for submission.
  • Support for the creation of statistical analysis plans and outputs based on ADaM datasets.

TFL programming

TLF programming

Our team is proficient in programming Tables, Listings, and Figures (TFLs) that are essential for clinical study reports (CSRs) and regulatory submissions. We use validated programming practices to generate accurate and reliable TFLs while adhering to industry standards. Our expertise ensures high-quality deliverables that meet client and regulatory expectations.

Key Deliverables:

  • Development of complex TFLs for clinical trial reporting.
  • Validation and quality control of TFLs to ensure accuracy and consistency.
  • Customization of TFLs to meet specific client or regulatory requirements.

ISS/ISE submission support

ISS/ISE submission support

We provide Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) submission support, which involves the integration and analysis of data from multiple studies. Our services include the preparation of combined datasets and the generation of integrated analysis results, ensuring consistency and compliance with regulatory requirements.

Key Deliverables:

  • Development of integrated datasets for ISS/ISE.
  • Programming and validation of TFLs for combined study data.
  • Preparation of submission-ready documentation and outputs to support regulatory filings.

Data monitoring committee/interim analysis support

Committee/interim analysis support

VAICS offers support for Data Monitoring Committees (DMCs) and interim analyses, providing the necessary programming and analysis to facilitate informed decision-making during clinical trials. We ensure that interim results are accurately generated and appropriately presented. Key Deliverables : Development of interim analysis datasets, Programming of interim TFLs for DMC review, Documentation and reporting to support interim analysis conclusions.

Data conversions

Data conversions

We assist with the conversion of legacy datasets to current CDISC standards, ensuring that older data can be effectively used in modern analyses and regulatory submissions. This includes the migration of datasets to SDTM and ADaM formats, while maintaining data integrity and compliance with industry standards.

Key Deliverables:

  • Conversion of legacy datasets to CDISC-compliant formats.
  • Validation of converted datasets to ensure accuracy and consistency.
  • Documentation of the conversion process and outputs for transparency and audit readiness.

Why choose VAICS for statistical programming?

VAICS combines technical expertise with a deep understanding of regulatory requirements to deliver reliable, high-quality statistical programming services. Our experienced team ensures that all deliverables are not only compliant with industry standards but also tailored to meet the specific needs of each client, providing a seamless experience from data preparation to submission.

Our approach:
At VAICS, we adopt a client-centric approach to biostatistics, working closely with you to understand your research goals and deliver tailored, high-quality solutions. Our focus on innovation, accuracy, and compliance ensures that our biostatistics and statistical programming services provide valuable insights and support the successful execution of your studies.

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