Equality Impact Assessment (EIA) Services

Equality Impact Assessment (EIA) Services

Expert EIA Guidance for Clinical Research

Ensure regulatory compliance while enhancing recruitment diversity and scientific validity. Our specialist EIA services help clinical trial sponsors avoid costly delays and rejection by meeting increasingly stringent equality requirements.

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Why Choose Nclusiv for Your Equality Impact Assessments?

Clinical trial sponsors face growing regulatory scrutiny of equality, diversity, and inclusion. Poorly conducted EIAs risk regulatory rejection, recruitment failures, and questionable data validity.

Our expert consultants have conducted EIAs for over 100 clinical trials across multiple therapeutic areas, ensuring both compliance and enhanced research outcomes.

Our EIA Methodology

Our comprehensive approach delivers both regulatory compliance and improved research quality:

Initial Scoping - We evaluate your protocol against current regulatory requirements

Data Analysis - We assess demographic patterns and potential barriers

Impact Evaluation - We identify specific protocol elements that may create barriers

Mitigation Strategy - We develop practical solutions that maintain scientific integrity

Documentation - We create comprehensive documentation for regulatory submission

Implementation Support - We provide guidance throughout the trial lifecycle

At Nclusiv we:

— Ensure regulatory compliance with HRA, MHRA, and international requirements for equality impact assessment in clinical trials.

— Identify and address barriers to participation that could limit recruitment from diverse populations.

— Enhance scientific validity by ensuring your trial population reflects real-world diversity.

— Accelerate approval timelines by providing comprehensive EIA documentation that meets or exceeds regulatory expectations.

— Improve recruitment efficiency by designing inclusive protocols from the outset rather than addressing issues reactively.

— Develop practical mitigation strategies that address equality concerns while maintaining scientific integrity.

— Provide expert guidance on evolving regulatory requirements and best practices in inclusive trial design.

— Support implementation with clear documentation, training, and ongoing advisory support throughout your trial.

Expert EIA Support for Specific Trial Types

Complex Therapeutic Areas

Trials in oncology, rare diseases, and neurology present unique equality challenges. Our specialists have conducted EIAs across numerous therapeutic areas and understand the specific considerations for different conditions.

Multi-site and International Trials

Navigating varying requirements across sites demands specialized expertise. We provide harmonized approaches that satisfy multiple regulatory frameworks while maintaining protocol consistency.

Pediatric Research

Special protections for minors create additional equality considerations. Our team includes experts in pediatric trial design who understand the unique balance of protection and inclusion required.

Our EIA Process

![EIA Process Diagram]

1. Initial Assessment

We begin with a comprehensive review of your protocol, identifying potential equality impacts and regulatory requirements.

2. Detailed Analysis

Our experts conduct in-depth analysis of how your protocol might affect different demographic groups, supported by demographic data and previous research.

3. Mitigation Development

We create practical mitigation strategies tailored to your specific protocol and research objectives.

4. Documentation Preparation

We prepare comprehensive documentation that satisfies regulatory requirements and supports implementation.

5. Implementation Support

Our team provides ongoing guidance to ensure effective implementation of mitigation strategies throughout your trial.

What Our Clients Say

"Nclusiv's EIA services transformed our approach to protocol design. Their insights not only ensured regulatory approval but significantly improved our recruitment rates across diverse populations."
Clinical Operations Director, Leading Pharmaceutical Company
 

"The EIA process with Nclusiv was remarkably efficient. Their expertise helped us navigate complex regulatory requirements while maintaining our scientific objectives."
Head of Research, UK Medical Research Institution
 

Frequently Asked Questions

When should we conduct an Equality Impact Assessment?

EIAs should be conducted during protocol development, not after finalization. Early assessment allows for meaningful modifications to study design rather than just documentation of issues.

What regulatory bodies require EIAs?

The Health Research Authority (HRA) in the UK requires equality considerations for all research approval. NHS organizations have specific EIA requirements for research conducted in their settings. The MHRA and EMA increasingly evaluate equality aspects during regulatory review.

How long does an EIA typically take?

A comprehensive EIA typically requires 2-4 weeks, depending on protocol complexity and therapeutic area. Expedited assessments can be arranged for urgent timelines.

How does an EIA differ from other ethical assessments?

While ethics committees focus on overall participant protection, EIAs specifically examine differential impacts across demographic groups. They complement rather than replace standard ethical review.

How do we demonstrate EIA compliance to regulators?

We provide comprehensive documentation specifically designed to satisfy regulatory requirements, including assessment methodology, findings, mitigation strategies, and implementation plans.

Trusted by Leading Research Organizations

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Book a Free Consultation with an EIA Specialist

Our EIA experts can evaluate your specific protocol and research needs to provide tailored guidance on ensuring both regulatory compliance and enhanced research quality.

[Form fields: First Name*, Last Name*, Organisation Name, Email*, Phone*, A brief description of your requirements*]