Biostatistics and Statistical Programming

Biostatistics and Statistical Programming

Comprehensive clinical and regulatory biostatistics and statistical programming services in all phases of drug and device development. Our Biostatisticians and statistical Programmers deliver accurate, High-quality, and timely Biostatistics Services. Our biostatisticians bring extensive experience of biostatistics services, from first-in-man to Phase IV trials, across a broad range of therapeutic areas. Statistical Programming team coordinate with the Medical Writing group to ensure accurate interpretation of study results. Our Biostatistician’s involved in all step of clinical research services like Clinical trial design, protocol creation, sample size determination, study endpoints, data management, data monitoring, data analysis, and clinical trial reporting.
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Our biostatistics and statistical programming proficiency goes hand-in-hand with our deep knowledge of complex indications and therapeutic areas. Our team successfully predicts risks, prevents delays, saves additional expenses, allocates resources wisely, and creates realistic timeframes thanks to years of experience planning and performing Phase I–IV clinical trials, integrated analytics, patient registries, and regulatory filings.

Our biostatistics and programming team has worked in a range of partnership models, such as full-service work with a project management team, standalone biostatistics and/or programming assistance with other vendors, consultancy support, and specialised resourcing models. We can serve as your primary statistical team to plan and conduct your clinical trial, or we can supplement and oversee your existing statistical team as needed.

Our biostatistics team can provide you with in-depth help for any difficult statistical needs. They join your core team and assist you in ensuring effective research design and planning. They are there to assist you in any manner when faced with difficult situations and decisions.

All biostatistics and programming outputs are adaptable and meeting to your specific requirements. Our adaptable approach to statistics and programming services is tailored to small and medium-sized businesses. We have an experienced staff, strong management oversight and participation, a track record of successful regulatory filings, and a broad range of therapeutic experience throughout all research phases.



Our statisticians frequently collaborate and meet with regulators in various therapeutic divisions, including standard and alternative regulatory paths such as orphan, breakthrough, and fast-track. Our team oversees timelines, handoffs, communication plans, and milestones across data vendors and all functional areas. Their work encompasses:
  • Randomization schedules, treatment kit lists, blind break documents,
    and masking plans
  • Customized tables, figures, and listings for Phase I-IV clinical trials
  • CDISC-compliant data packages
  • CDISC database standardization and legacy conversions.
  • Analysis planning
  • Output generation
  • Data interpretation
  • Data integration and integrated summaries (ISS/ISE)
  • Interim analysis (futility, sample size re-estimation, efficacy, endpoint
    reviews) and safety updates
  • Supportive analyses for publications, manuscripts, scientific
    presentations, abstracts, etc.
  • Review of data management documents and database setup

Statistical Programming

Our team has CDISC expertise and can set up a CDISC strategy that aligns with business, financial, and regulatory objectives. We have produced CDISC, SDTM, and ADaM-compliant datasets for over 40 research and have made several CDISC- compliant regulatory filings. Our experience includes:
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  • Designing Statistical analysis plan (SAP)
  • Creating Programming specifications for documents for all types of data (SDTM, ADaM, Derived data, etc). o SDTM (Study Data Tabulation Model) compliant analysis datasets o ADaM (Analysis Data Model) compliant analysis datasets
  • SDTM and ADaM domains (SAS datasets/transport files)
  • SDTM annotated CRF (acrf.pdf)
  • Define.xml files for SDTM and ADaM
  • Study program guides that provide details on how programs and macros are used to create the SDTM and ADaM domains

  • Development of SAS programs for study TFLs, based on study SAP and shells.
  • Randomization /Unblinding support
  • Validation of datasets via Independent double programming
  • Preparing Statistical Report / Clinical Study Report – our statistical and medical writing teams collaborate to produce high-quality reports.
  • Participate independently in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.

Biostatistical Consulting

We collaborate with your team to establish essential regulatory, corporate, and scientific objectives. The objectives are then incorporated into strong research designs that prioritise important goals and de-risk the development programme at crucial go/no-go decision points.

Our team can support for:

  • Study design and sample size calculations
  • Development plan
  • Regulatory assistance, representation, and submissions
  • Scientific review panels and data monitoring committees
  • Plan for Strategic product development.
  • Development of individual research protocols, such as unique and complicated trial designs, adaptive trial design, real-world evidence and/or other external controls, natural history studies, and patient registries
  • Exploratory studies for corporate or scientific purposes


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