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CLINICAL TRIAL MANAGEMENT

Biostatistics

Linical has a deep understanding of biostatistical services and the importance of providing valuable upfront study design input and recommendations. Prioritizing data quality and efficiency, Linical’s biostatistics team is your dedicated partner, providing end-to-end support throughout your clinical trial. From planning to close out, clients count on Linical to mitigate risks, avoid unnecessary costs, and drive study timelines.
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Linical’s nimble approach for statistical programming services is tailor-made for your clinical trial.

Clinical Biostatistics Services

Statistical methods are essential to obtain objective conclusions from the data collected during the study and to provide a sound scientific basis for evaluating the efficacy and safety of new drugs or medical interventions. Linical statisticians leverage their industry experience across multiple therapeutic areas and complex indications, ranging from early phase to late phase trials, to provide professional support to sponsors throughout their entire clinical trial.

We combine our biostatistics and statistical programming capabilities with extensive experience and regulatory knowledge, working with a flexible approach while focusing on efficiency, optimization of resources, and compliance with established timelines.

Our Biostatistics team gets involved in the study from start to finish monitoring deadlines, milestones, and handoffs. We collaborate with Sponsors to achieve the goal of providing high-quality, clean data for regulatory approval. We recommend biostatistical methods, define endpoints, and fine tune analysis populations. Using real-time data and best in class systems, we proactively identify risks and trends throughout the course of your study, then deliver a CDISC package with data sets, reviewer’s guides, and a detailed analysis.

Your Trusted CRO for Biostatistics

Lincal provides comprehensive biostatistics services including:
Planning, clinical trial design, and protocol development
Sample size/statistical power determination
Randomization schedule generation
Development of statistical analysis plans (SAP) and analysis
Development of tables, listings, and figures (TLFs)
Statistical modeling and simulation
Data and Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC) support
Interim analysis and final reporting
Clinical study report
CDISC programming and documentation
CDISC-compliant data packages
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
eCTD submissions
Annual report (DSUR and PSUR)
Observational Studies, RWE, and HEOR and Payer Analysis
Publications
Statistical consulting
Right Size
Right Reach
Right Team

Statistical Programming for Clinical Trials

Linical’s experienced statistical programmers empower clients with high-quality, data driven insights. Our statistical programming capabilities include:
Integrated SDTM/ADaM Data Packages (ISS/ISE/ISI) Preparation
Office of Scientific Investigation (clinsite.xpt, define.xml, reviewers guide and OSI listings)
CRF, SAP Review and Inputs
Patient Profiles
SDTM Data Package Preparation
ADaM Data Package Preparation
PK/PD Dataset Preparation
Data Exploration and Programming Automation
Linical
OUR BENEFITS

Why Linical?

The clinical development journey can be daunting and often leads to failure. With so much riding on your compound, you deserve the best chance at achieving your goals and positively impacting patients across the globe.

As a global, award-winning CRO, we can provide the strategy and support you need to position your clinical trial for success. We have an impressive track record of exceeding our enrollment goals and maintaining nearly a 90% client retention rate.

With our collaborative approach and commitment to quality, Linical expertly guides you through each step of the process, from early-phase research to large-scale global studies. With Linical, you can overcome obstacles, expedite timelines, save valuable money, and achieve your goals without compromising quality.

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Successful clinical trials start with Linical.

Don’t let the complex clinical development journey hold you back. With Linical, you can overcome obstacles, save valuable time and money, and reach your goals. 

01 Request a proposal

We start by listening to your needs and understanding your goals to ensure we’re the right CRO for you.

02 Get a plan for success

We propose solutions that proactively tackle obstacles, optimize your trial design, and position you for success every step of the way.

03 Execute with confidence

We’ll guide you through each phase of the process, offering personalized support and a full range of services to help you achieve a successful trial. We are not a “one size fits all” CRO.

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