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Clinical Trial Support That Moves You Forward

Bringing a medical device to market, whether diagnostic, therapeutic, software-based, or implantable, depends on clinical evidence that’s not only scientifically sound but also aligned with evolving regulatory expectations. That’s where Rook Quality Systems comes in.

Whether you're preparing for a first-in-human study or managing multiple clinical investigations across your portfolio, Rook delivers strategic, compliant, and efficient clinical trial support that helps you move faster, reduce risk, and achieve regulatory success with confidence.

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Clinical Expertise LP (6)

End-To-End Clinical Trial Support

For Medical Devices

We specialize in providing clinical trial support services rooted in regulatory, quality, and compliance expertise. From early protocol planning to submission-ready documentation, Rook helps you build a rock-solid foundation for clinical success.

Step 1

Regulatory Planning & Study Design

Lay the foundation for a successful clinical or usability study with strategic regulatory insight.

  • Initial regulatory review to determine validation study requirements
  • Support for FDA pre-submission meetings to align on study scope
  • Guidance on IRB and/or IDE approval requirements

Step 2

Protocol & Documentation Development

Ensure your study is supported by strong, submission-ready documentation.

  • Drafting of clinical and usability study protocols 
  • Preparation of supporting materials for IRB and/or IDE submissions
  • Survey creation and documentation tailored to study endpoints

Step 3

Usability Validation & Risk Analysis

Demonstrate safe, effective use with expert-led human factors validation.

  • Usability risk analysis and use-related hazard assessments
  • Support for usability protocol design and execution 
  • Oversight of formative and summative usability testing 

Step 4

Clinical Execution & Real-Time Monitoring

Accelerate your study timeline with decentralized trials and live data insights.

  • Access to Rook's decentralized clinical trial (DCT) partner platform
  • Real-time clinical data monitoring throughout the study
  • Issue tracking and compliance oversight during trial execution  

Step 5

Final Reporting & Submission Support

Translate study results into regulatory-ready submissions.

  • Clinical data analysis and interpretation 
  • Development of the final clinical or usability validation report 
  • Integration of results into FDA submissions

End-To-End Clinical Trial Support for Medical Devices

We specialize in providing clinical trial support services rooted in regulatory, quality, and compliance expertise. From early protocol planning to submission-ready documentation, Rook helps you build a rock-solid foundation for clinical success.

Regulatory Review & Strategy

Initial Regulatory Assessment → Analyze device classification and define validation study requirements

FDA Meeting Support → Prepare for and participate in FDA pre-submission meetings to confirm study scope

IDE / IRB Planning → Advise on IDE exemption analysis and align documentation for IRB approval 

Protocol Development & Documentation

Clinical Protocol Drafting → Development of clear, compliant clinical study protocols tailored to regulatory needs.

Usability Protocol Creation → Design human factors protocols aligned with FDA expectations for use safety.

IRB/IDE Support Documentation → Prepare supporting documents required for IRB or IDE submission.

Usability Validation Support

Usability Risk Analysis → Conduct use-related hazard analyses to meet human factors requirements.

Survey & Tool Development → Create validated surveys and tools to support usability data collection. 

Usability Study Oversight → Guide execution of formative and summative usability testing.

Decentralized Clinical Trial Solutions

DCT Platform Access → Partnered access to a decentralized clinical trial solution for faster, cost-effective execution.

Participant Recruitment & Management → Streamline recruitment and engagement through virtual trial tools.

Remote Data Collection → Enable real-time, secure collection of trial data from participants.

Real-Time Monitoring & Oversight

Live Data Review → Conduct real-time monitoring of clinical data to ensure protocol adherence.

Issue Management & Resolution → Track, document, and resolve study deviations or usability issues.

Compliance Oversight → Maintain GCP-aligned documentation and readiness throughout the study. 

Reporting & Submission Integration

Final Clinical Report Development → Analyze and compile results into a comprehensive, submission-ready report.

FDA Submission Preparation → Integrate study data seamlessly into 510(k), De Novo, or EUA submissions.

Formatting & QMS Alignment → Ensure clinical documentation aligns with Quality Management System requirements.

Step 1

Regulatory Planning & Study Design

Lay the foundation for a successful clinical or usability study with strategic regulatory insight.

  • Initial regulatory review to determine validation study requirements
  • Support for FDA pre-submission meetings to align on study scope
  • Guidance on IRB and/or IDE approval requirements

Step 2

Protocol & Documentation Development

Ensure your study is supported by strong, submission-ready documentation.

  • Drafting of clinical and usability study protocols 
  • Preparation of supporting materials for IRB and/or IDE submissions
  • Survey creation and documentation tailored to study endpoints

Step 3

Usability Validation & Risk Analysis

Demonstrate safe, effective use with expert-led human factors validation.

  • Usability risk analysis and use-related hazard assessments
  • Support for usability protocol design and execution 
  • Oversight of formative and summative usability testing 

Step 4

Clinical Execution & Real-Time Monitoring

Accelerate your study timeline with decentralized trials and live data insights.

  • Access to Rook's decentralized clinical trial (DCT) partner platform
  • Real-time clinical data monitoring throughout the study
  • Issue tracking and compliance oversight during trial execution  

Step 5

Final Reporting & Submission Support

Translate study results into regulatory-ready submissions.

  • Clinical data analysis and interpretation 
  • Development of the final clinical or usability validation report 
  • Integration of results into FDA submissions

Accelerate Your Clinical Trial Success with RookQS

Whether you need guidance on a single study or support across your product lifecycle, Rook is your partner in building a smarter, faster, and more compliant path to market.

Get Started with Expert Clinical Trial Support
Clinical Expertise LP (4)

Plan With Confidence

Design your clinical trial for success with strategic regulatory guidance from our experienced team, accelerating your path to market.

  • Clinical trial strategy aligned with FDA 510(k), De Novo, or EUA pathways 
  • IDE exemption analysis
  • FDA regulatory planning and communication
Clinical Expertise LP (2)

Build It Right from the Start

Craft clear, detailed trial documentation, ensuring regulatory compliance and data integrity.

  • Clinical protocol development and review
  • Human factors and usability validation planning
  • Risk management file updates based on trial design 
  • Investigational labeling and IFU review 
Clinical Expertise LP (5)

Stay Trial-Ready

Expert compliance support to ensure your trial maintains regulatory compliance, safety, and efficacy.

  • GCP-aligned documentation and compliance oversight
  • Audit readiness for trial-related records
  • CAPA support for deviations or usability issues
  • Clinical trial-related SOPs, forms, and training materials
Clinical Expertise LP (7)

Connect Trial to Market Clearance

Seamlessly integrate clinical trial data with FDA submission, ensuring proper formatting and QMS alignment.

  • Incorporation of clinical results into 510(k), De Novo, or eSTAR submissions
  • Clinical study summary report review and formatting
  • Verification and validation alignment with QMS requirements

Why Partner with Rook?

Decades of FDA Submission Experience

With over a decade of hands-on experience, Rook has led successful FDA submissions across 510(k), De Novo, and EUA pathways, ensuring your clinical strategy meets regulatory expectations from day one.

Full-Spectrum Device Expertise

Whether your product is software-driven, diagnostic, or hardware-based, our team delivers tailored clinical and regulatory support for your specific device type.

Trusted by MedTech Innovators Globally

Backed by a strong history of guiding 300+ medical device companies through regulatory milestones, Rook brings proven quality and regulatory expertise to every new clinical trial engagement.

Seamless Collaboration Across Teams

We work directly with your CRO, lab, or digital platform to ensure your clinical trial runs smoothly, coordinating compliance, documentation, and communication from start to finish.

LaunchDx

Your Fast-Track Track to Market

Bringing an at-home diagnostic test to market comes with unique regulatory, quality, and clinical challenges. That’s why Rook Quality Systems has partnered with Safe Health Systems to create LaunchDx.

A comprehensive solution to launch at-home diagnostic tests faster with expert support in FDA strategy, remote clinical validation, and digital health integration.

  • Flexible Integration – Fits into your tech stack and go-to-market plan.
  • Smarter Decisions – Real-time data for product improvement
  • Continuous Improvement – Post-launch analytics and compliance tracking
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