What is Statistical Analysis for Clinical Trials
Statistical Analysis Services Include:
A well-planned and correctly executed statistical analysis is essential for regulatory approval, publication and real-world impact.
Statistical Analysis Plans (SAPs)
EvoClinical authors or audits SAPs that define exactly how your clinical data will evaluate 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, figures and listings (TFLs).
The result is a blueprint that aligns statisticians, clinicians, programmers, and regulators before the first record is locked.
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, Figures & Listings (TFLs)
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
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 TFLs, or contributed to the CSR or Briefing Package. This service includes being on-call to quickly respond to inquiries from the regulatory authority.
Why Statistical Analysis matters
Investigational products receive or are denied market approval on the strength of their clinical trial statistical analyses.
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.
Statistical Analysis Services
Why Clients Choose EvoClinical
Deep Expertise
Decades of hands-on consulting experience with statistical knowledge relevant to numerous trial requirements.
Accreditations
ASA / SCC accreditation for statisticians and SAS certified programmers
Therapeutic Diversity
From oncology to rare disease to CNS, we tailor strategies to your therapeutic area.
Cross-Functional Insight
Understanding 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.
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.