Biostatistics & Statistical Programming
Biostatistics Services Backed by Experience, Flexibility, and Quality
Summit Analytical, a division of Lotus Clinical Research, delivers biostatistical support across the full development lifecycle—from early-phase trials to post-marketing and real-world evidence studies. Our experienced biostatisticians lead every study, working closely with project teams to ensure scientifically sound, timely, and regulatory-aligned results. With deep expertise across Phase I–III, proof of concept, and epidemiology studies, we tailor our services to meet the unique needs of each trial, offering full-service support or modular solutions as needed.
Biostatistics Services That Move Trials Forward
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With decades of experience and a deep understanding of regulatory expectations, our biostatistics team provides end-to-end support across clinical trial design, analysis, reporting, and submission. Whether you need comprehensive oversight or targeted expertise, our services are designed to ensure accuracy, compliance, and strategic value at every stage.
Clinical Trial Planning & Design
- Protocol and CRF consultation and review
- Research and selection of appropriate statistical methods
- Sample size calculations and simulations for optimal design
- Randomization schedules
- Statistical Analysis Plan (SAP) development including TLF shells
Programming, Analysis & Reporting
- Development, documentation, and validation of:
- Derived Datasets, Tables, Listings, and Figures (TLFs)
- CRF tabulations and Patient profiles
- Support for interim analyses and Data Monitoring Committee (DMC)
- Exploratory and market support analyses
- Stats Reports (CSR, Manuscripts, IB)
CDISC Compliance & Standards
- Study Data Standardization Plans (SDSP)
- Creation of clinical SDTM and ADaM and non-clinical SEND compliant datasets
- Define documentation (PDF or XML backbones)
- Reviewer guides
- Remapping legacy studies to meet regulatory compliant data submission standards
Statistical Regulatory Support
- Application support: NDA, SNDA, ANDA, BLA, PMA, and 510(k)
- Integrated Summaries of Safety and Efficacy (ISS and ISE)
- eCTD statistical summaries for Modules 2 and 5
- Regulatory meeting support and representation
- Pre-IND, EOPII, Pre-NDA, and FDA Advisory committees
Advanced Statistical Expertise Beyond Standard Biostatistics
Our team offers a rare depth of specialized statistical services that go well beyond conventional analyses. Leveraging sophisticated methodologies—from mixed-effects modeling to complex survey design and simulation—we provide sponsors with robust, scientifically rigorous insights that many other providers cannot. This expertise enables more precise data interpretation, better handling of missing data, and validated patient-reported outcomes, ultimately strengthening your study’s impact and regulatory readiness.
Adaptive Design Support
Simulation & Resampling Methods
Mixed-Effects Models
Estimand Framework
Survival Analysis
Missing Data Modeling
Exploratory & Correlation Modeling
Expert Guidance for Complex Statistical Challenges
In addition to full-service biostatistics, Summit Analytical offers targeted consulting and planning support to help sponsors navigate complex study designs, regulatory strategy, and global development programs. Whether you’re refining endpoints, preparing for regulatory meetings, or aligning with market access requirements, our senior team is here to guide your path with clarity and confidence.
Regulatory Data Standards (CDISC)
Our team brings deep expertise in regulatory data sciences and ensures full compliance with FDA-mandated data standards for clinical and non-clinical submissions. We support sponsors through every stage of submission preparation with the following services:
- Study Data Standardization Plans (SDSP):
We develop and maintain SDSPs as required by the FDA for IND submissions, ensuring consistency across your entire clinical development program. Our team implements and updates the plan throughout the product lifecycle, aligned with FDA guidance on standardized study data.
- SEND Dataset Development (Non-Clinical):
We efficiently create and validate fully documented, submission-ready SEND datasets for toxicology, ADME, and non-clinical PK/PD studies. This service is seamlessly integrated with our toxicokinetics support.
- SDTM and ADaM Compliance (Clinical):
We produce high-quality SDTM and ADaM datasets that meet CDISC requirements, ready for submission and long-term use across the drug or device lifecycle.
Clinical Trials: SDTM and ADaM
Summit Analytical specializes in the efficient development, validation, and delivery of CDISC-compliant clinical datasets that are fully documented and submission-ready. We support the full range of clinical data standardization, from raw collection to analysis datasets.
As part of our Regulatory Data Standards and Compliance services, we provide:
SDTM Deliverables:
- SDTM specifications and Annotated CRF
- SDTM domains
- SDTM Define.xml and Study Data Reviewer’s Guide (SDRG)
ADaM Deliverables:
- ADaM specifications aligned with planned analyses
- ADaM datasets
- ADaM Define.xml and Analysis Data Reviewer’s Guide (ADRG)
Our team ensures your clinical trial data is aligned with CDASH, SDTM, and ADaM standards—enabling seamless regulatory submission and long-term data utility.
Statistical Report Writing
Summit Analytical understands a well-written study report is critical to presenting study results. We are experienced in working with clinical teams to generate high-quality study reports, statistical reports, and manuscripts. Summit Analytical can fully support clients with writing or reviewing in the following areas:
- Study protocols and amendments
- Statistical sections of CSRs, in collaboration with sponsor medical writers
- Statistical Reports
In addition to study specific report writing our team supports clients with integrated statistical and writing services to support:
- Regulatory documents to support meetings and submissions
- Manuscript preparation
- Professional meeting preparations (posters and slide decks)
- Promotional and educational materials for medical education
Statistical Programming
Summit Analytical’s seasoned programming team provides high-quality SAS Software® programming in close collaboration with statistical leads. Our programmers are deeply experienced in delivering regulatory-compliant, CDISC-standard datasets and outputs that support data management, statistical analysis, and submission readiness.
We offer:
CDISC-Compliant Dataset Programming
- SDTM specifications and Annotated CRF
- Development and validation of SDTM and ADaM datasets
- Define.xml files (SDTM and ADaM) and reviewer guides (SDRG and ADRG)
Statistical Outputs
- Statistical Tables, Listings, and Figures (TLFs)
- CRF tabulations and patient profiles
- Data management and quality control listings
- Independent programming support for DMC/DSMB meetings
Legacy and Custom Solutions
- Remapping of legacy studies to meet submission standards
- Development and maintenance of validated macro libraries
- Programming tailored to unique project needs
Our programming services ensure accuracy, compliance, and efficiency at every stage of clinical development.
Statistical Consulting & Planning
Our experienced team delivers high-value statistical consulting and program-level planning across the full product development lifecycle. At Summit Analytical, we understand the strategic role an expert biostatistician plays in shaping successful development programs—and we embed that expertise directly into your team.
We provide tailored support for:
- Designing target product profiles (TPPs) and clinical development plans (CDPs)
- Program-level statistical strategies for endpoints and assessments by phase
- PK/PD planning for integrated development strategies
- Global regulatory statistical planning (INDs, NDAs, BLAs, ANDAs, IMPDs, PLAs, PMAs, 505(b)(2), and 510(k))
- Regulatory meeting prep and biostatistical representation (Pre-IND, EOP2, Pre-NDA/BLA, Type C)
- Advisory committee statistical support and presentation development
Market Access Support:
- EU/NICE/government payer panel analysis and reporting
- U.S. insurance and P&T committee cost-benefit analyses
Statistics Training & Development
At Summit Analytical, we believe informed partners lead to stronger studies. Our senior staff—many of whom have held academic appointments at U.S. universities—offer tailored training programs to help clients understand the evolving landscape of statistical and regulatory data sciences in clinical trials.
We provide customizable training in:
- Clinical trial design and analysis
- Statistics for the non-statistician
- CDISC SDTM and ADaM fundamentals
- Regulatory data sciences
All programs are available onsite or via live web presentations and can be customized to match your team’s experience and needs.
