What are Regulatory Support Services for Clinical Trials?
Regulatory support services for clinical trials focus on helping sponsors prepare, refine and defend the statistical and data-driven elements of their submissions to health authorities. Unlike full regulatory services, which include authoring clinical trial applications or navigating procedural submissions, regulatory support services are highly specialized, ensuring that data, analyses, and study designs are presented in the clearest and most scientifically defensible way.
EvoClinical’s Regulatory Support Services
Our regulatory support services are designed to help sponsors succeed in scientific and statistical interactions with health authorities, without replacing or duplicating regulatory affairs teams.
Sponsors typically seek EvoClinical’s expertise when:
- Preparing for FDA, EMA, or Health Canada meetings.
- Drafting statistical justifications for study designs.
- Submitting data-driven evidence packages
- Responding to regulatory authority questions on endpoints, analyses, or missing data handling.
- Needing independent statistical review of regulator-facing documentation.
Data Package Preparation
-Development of integrated statistical data summaries.
-Preparation of regulator-facing datasets aligned with CDISC/ICH standards.
-Audit-ready TFLs for inclusion in regulatory filings.
Briefing Documents & Statistical Content
-Authoring or reviewing statistical sections of briefing packages.
-Ensuring clear rationale for study designs, endpoints, and estimands.
-Alignment with ICH E9, FDA, EMA, and Health Canada statistical guidance.
Tables, Figures & Listings (TFLs) for Submission
-Creating regulator-ready TFLs to support efficacy and safety results.
-Highlighting critical analyses that address potential authority concerns.
Meeting Participation & Advisory
-When necessary, Statisticians join sponsor teams during FDA, EMA, and Health Canada interactions.
-Provide live support during Q&A, ensuring statistical accuracy in responses.
-Advising on follow-up materials after pre-IND/CTA, End-of-Phase II, or pre-submission meetings.
Drafting Responses to Authority Questions
-Supporting sponsors in preparing written responses to regulatory queries.
-Ensuring consistency between narrative responses and statistical evidence.
-Helping frame explanations that maintain scientific credibility and regulatory trust.
Why Regulatory Support Services Matter
Regulatory interactions are often pivotal inflection points for clinical programs. Authorities evaluate not only whether a study is well-designed, but also whether analyses and justifications are scientifically rigorous and clearly communicated.
Strengthens Regulatory Submissions
Expertly prepared data packages and briefing materials build confidence and credibility with authorities.
Reduces Risk of Delays
Anticipating authority questions and preparing accurate responses helps sponsors avoid costly submission setbacks.
Keeps Study Options Open
Strong statistical justifications prevent premature rejection of preferred designs or endpoints.
Provides Scientific Clarity
Complex analyses are transformed into regulator-ready narratives supported by clear TFLs and data summaries.
Regulatory Support Services
Why Clients Choose EvoClinical
Focused Scope
We specialize in the statistical aspects of regulatory support, not full regulatory submissions.
Collaborative Approach
Seamless integration with sponsor regulatory and clinical teams.
Deep Experience
Decades of biostatistical expertise across therapeutic areas and global submissions.
Regulatory Alignment
We adhere to FDA, EMA, Health Canada, and ICH statistical guidelines.
Want an edge with regulatory authorities?
EvoClinical provides scientific expertise during authority meetings, we help sponsors anticipate regulator questions, avoid flawed trial designs, and maintain flexibility in study strategies.