What is Statistical Analysis for Clinical Trials
Statistical analysis for clinical trials is the process of applying mathematical methods to evaluate and interpret trial data in order to draw valid, scientifically credible conclusions. It ensures that the results of a study, whether related to efficacy, safety or tolerability, are not due to chance and can be confidently generalized to the target population.
Statistical analysis plays a critical role in determining whether a treatment works, how strong the effect is and how consistent it is across different subgroups. Regulatory agencies like the FDA, Health Canada and EMA rely heavily on robust statistical evidence to assess the benefit-risk profile of investigational products. A well-planned and correctly executed statistical analysis is essential for regulatory approval, publication and real-world impact.
Statistical Analysis Services for Clinical Trials
Clinical trials rise or fall on the strength of their statistics. Statistical analysis from EvoClinical’s senior biostatisticians, programmers, and data scientists transform raw study data into clear, defensible evidence that speeds decisions and satisfies global regulators.
Stronger Decision-Making
Expert statistical insight empowers sponsors to make informed, data-driven decisions throughout the trial lifecycle.
Greater Regulatory Success
Statistical consultants align your trial design with agency expectations, reducing the risk of regulatory pushback.
Cost Efficiency
Avoids over-enrollment, rework, and delays by guiding resource-efficient designs from the start.
Faster Trial Timelines
Well-designed studies reduce protocol amendments, improve recruitment, and streamline the path to regulatory milestones.
Improved Data Credibility
A sound statistical framework ensures data integrity, increasing confidence among regulators, partners, and investors.
Competitive Advantage
Strategic statistical input helps differentiate your trial in crowded therapeutic areas or high-stakes indications.
Turn clinical data into decisive evidence
Our statistical analysis services are vast; from statistical analysis plans, interim & final analyses, completing study sample calculations, to statistical programming. We can employ a wide range of statistical methods to help de-risk development and accelerate your study statistical goals.
Statistical Analysis Services Includes:
Statistical Analysis Plans (SAPs)
EvoClinical authors or audits SAPs that define exactly how your clinical data will prove safety and efficacy. We specify analysis populations, model-building logic, hypothesis tests, confidence intervals, rules for intercurrent events and missing data, and the full shell of tables, listings, and figures (TLFs).
The result is a blueprint that aligns statisticians, clinicians, programmers, and regulators before the first record is locked.
Statistical Programming & CDISC Data Sets
- Our programmers convert raw capture files into analysis-ready datasets at three precision levels:
- Analysis-Ready (non-CDISC) – fast turnarounds when submission isn’t required.
- CDISC-Structured – SDTM and ADaM domains that follow CDISC layouts but stop short of full submission packaging.
- CDISC Submission Package – adds Define-XML, Reviewer’s Guide, and study-level domains, giving regulators everything they need to validate your application without delay
Tables, Listings & Figures (TLFs)
We generate ICH-compliant tables, patient listings, and graphical figures that succinctly list, summarise, and visualise endpoints.
Randomization Codes
Whether you need simple, stratified, permuted-block, or response-adaptive randomization, we craft the schema, generate secure treatment codes (e.g., drug-kit IDs), and deliver import-ready files for any IWRS/RTSM platform, ensuring allocation concealment and auditability from day one.
Interim & Final Analyses
An interim analysis refers to an analysis done using a portion of the expected data, e.g., when 50% of the study participants have completed the primary endpoint. An interim analysis is often limited to safety endpoints and the primary and key secondary efficacy endpoints. A final analysis is conducted immediately after the study has terminated and covers all endpoints and all data.
Safety Data Summaries
Independent safety monitoring committees rely on accurate, up-to-the-minute data. EvoClinical prepares periodic safety listings, tables, narratives, and interactive dashboards that spotlight adverse-event trends and help committees decide, quickly and confidently, whether a trial should continue as planned.
Integrated Safety & Efficacy Summaries
Integrated summaries combine data from different clinical studies to provide information regarding safety or efficacy for a development program spanning multiple studies. This service prepares integrated data sets, tables and listings, and documentation according to standards required for submission to a regulatory authority.
CSR Statistical Reviews
A senior statistician reviews your Clinical Study Report to verify table/figure accuracy and ensure every statistical statement is methodologically sound. This proactive audit minimises regulator questions and last-minute CSR revisions.
Submission & Regulatory Support
EvoClinical will support sponsors’ submissions to regulatory authorities when we prepared the data submission package or TLFs, or contributed to the CSR or Briefing Package. This service includes being on-call to quickly respond to inquiries from the regulatory authority.
Why Clients Choose EvoClinical
Our team brings decades of biostatistical expertise to every engagement, helping sponsors navigate trial complexity with confidence and clarity.
Deep Expertise
Decades of hands-on consulting experience with deep statistical knowledge relevant to numerous trial requirements.
Strategy First
We approach each engagement as advisors, not just service providers. Our consulting model is collaborative and transparent.
Therapeutic Diversity
From oncology to rare disease to CNS, we tailor strategies to your therapeutic area.
Cross-Functional Insight
We understand how statistics intersect with regulatory, operational, and therapeutic area needs.
Senior Talent Only
Your consulting engagement is led by our senior experts; all of whom have advised across successful submissions and therapeutic areas.
Regulatory Alignment
We don’t just know the stats; we know what regulators expect, and how to deliver it.