What is Statistical Consulting for Clinical Trials
Common Consulting & Advisory Engagements
Here is a sample list of common consulting & advisory engagements. These reflect strategic, guidance-based contributions.
Protocol Review
Assessing or advising on the statistical methodology sections of draft protocols for clarity, alignment, and regulatory expectations.
Trial Design Evaluation & Recommendations
Advising on the most appropriate design based on objectives, indication and constraints.
Sample Size & Power Analysis Review
Reviewing assumptions and calculations, advising on optimal power levels and justifications for regulatory or investor confidence.
Endpoint Selection & Justification
Advising on primary/secondary endpoint appropriateness and measurement timing.
Regulatory Meeting Preparation
Advising on statistical talking points, questions to anticipate, and documentation strategies for agency meetings or responses.
Adaptive Design Feasibility
Assessing appropriateness and advising on the structure of adaptive features
Rescue Consultation on At-Risk Trials
Evaluating underperforming trials and advising on statistical redesign, re-powering, or re-alignment strategies.
Competitor Landscape
Advising how to design a trial to differentiate from competing studies in terms of endpoints, design, or evidence strength.
Real-World Evidence (RWE)
Incorporating RWE into trial planning to inform study design, support regulatory strategy, or augment trial results with real-world context.
Enrollment Forecasting
Using publicly available registry data and proprietary tools to model recruitment timelines, identify enrollment challenges early, and support feasibility assessments.
Why Your Statistical Strategy matters
The quality of your statistical design, analysis strategy, and regulatory documentation directly impacts trial timelines, data integrity, and submission outcomes. In an increasingly complex regulatory and scientific environment, statistical guidance must be precise, scalable, and proactive.
The benefits of our statistical consulting and advisory services include:
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 Consulting
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.
Talk to Statisticians Who Understand Clinical Trials
Statistical strategy can make or break your clinical development program. Whether you’re designing your first protocol or responding to a regulatory agency, EvoClinical brings the insight and clarity you need to move forward with confidence.