Robotic Surgery Clinical Investigation

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The Challenge

A global medtech company developing a next-generation robotic surgical platform needed comprehensive CRO support to deliver a pivotal clinical investigation in the UK. The system had already completed hundreds of procedures internationally, and this would be the platform's first UK study to assess system safety, usability, and performance in the NHS setting.

The sponsor had already selected their surgical site but required a CRO with specialist expertise to:

• Manage complex regulatory submissions for MHRA and REC approval
• Coordinate study start-up at a single complex surgical centre
• Provide protocol and patient-facing document development in collaboration with site and sponsor
• Provide ongoing operational oversight in a complex surgical environment
• Ensure GCP and ISO 14155 compliance throughout the investigation
• Deliver full trial management services, statistics, data management and monitoring

This required a CRO with deep expertise in medical device investigations, surgical trial logistics, and the regulatory complexities of pivotal studies.

Our Role: Comprehensive End-to-End CRO Support

Regulatory & Ethics Submissions

We prepared and submitted all documentation for MHRA Clinical Investigation Authorisation and Research Ethics Committee approval, securing regulatory authorisations ahead of the sponsor's planned timeline.

• MHRA Clinical Investigation Application (UK MDR 2002)
• Research Ethics Committee (REC) submission
• Clinical Investigation Plan (CIP) development and review
• Protocol and patient-facing document development in collaboration with site and sponsor
• Risk management documentation and safety reporting procedures
• ISO 14155 compliance framework implementation

Study Start-Up & Site Activation

We coordinated comprehensive study start-up activities at the selected surgical site:

• Site contracting and essential document collection
• Investigator and surgical team training on study procedures
• Site Initiation Visit (SIV) with complete protocol walk-through
• EDC system setup and user training
• Adverse event and device deficiency reporting procedure training

Ongoing Clinical Operations & Trial Management

Our team provides continuous operational support, full trial management services, and monitoring throughout the active study:

• Regular site contact and communication with the surgical team
• Protocol adherence monitoring and query resolution
• Real-time support during surgical procedures
• Continuous GCP and ISO 14155 compliance oversight
• Safety signal monitoring and adverse event management
• Device deficiency documentation and reporting
• Coordination between sponsor and clinical team
• Support for protocol deviations and amendments

Data Management, Statistics & Monitoring

• EDC system management and user support
• Real-time data quality review and query generation
• Data validation and cleaning procedures
• Preparation of interim data outputs for sponsor review
• Statistical analysis planning for final reporting
• Comprehensive site monitoring activities

Quality & Risk Oversight

• Proactive quality management throughout the study lifecycle
• Risk-based monitoring approach tailored to surgical complexity
• Internal quality audits of study processes
• Patient safety safeguarding procedures
• Regulatory inspection readiness

Current Progress

The study is actively ongoing with the site open and recruiting participants across 2 surgical specialities. Early procedural data demonstrates:

• Strong protocol adherence across both surgical specialities
• High investigator engagement and positive surgical team feedback
• Excellent collaboration between the surgical team and sponsor
• Robust data quality with minimal queries and protocol deviations
• Consistent safety profile with appropriate adverse event and device deficiency documentation

Our team continues to provide hands-on operational support, quality oversight, and regulatory management to maintain study momentum and ensure high-quality data delivery as the investigation progresses toward completion.

Expected Outcomes

Once complete, the trial will generate critical data on:

• System safety profile in real-world UK surgical settings
• Surgical team usability assessment
• Technical performance across 2 surgical specialities
• Procedural efficiency and operative time comparisons
• Patient outcomes and recovery profiles

This evidence will support the sponsor's regulatory strategy and progression to broader market access in the UK and EU.

Why This Demonstrates Our Expertise

Surgical Trial Specialisation

Managing pivotal robotic surgery investigations requires specialist CRO capabilities that go beyond standard clinical trial experience. Our team brings deep understanding of surgical workflows, operating theatre logistics, and the unique challenges of evaluating complex medical devices in live surgical environments.

Regulatory Excellence

Navigating MHRA approval and ISO 14155 compliance for innovative surgical technology demands sophisticated regulatory expertise. We secured approvals ahead of schedule and maintain continuous compliance throughout the ongoing investigation.

Multi-Stakeholder Coordination

Success in surgical device trials requires seamless coordination between surgeons, theatre staff, sponsor teams, hospital administrators, and regulatory bodies. Our operational excellence ensures all parties remain aligned and engaged throughout the study.

Data Quality in Complex Settings

Collecting high-quality data during live surgical procedures presents unique challenges. Our EDC systems, training, and real-time support ensure consistent, complete data capture even in demanding surgical environments.

Study Details

Impact

This pivotal robotic surgery investigation demonstrates how expert CRO collaboration can support cutting-edge surgical innovation — managing regulatory complexity, site coordination, and data integrity in a sophisticated single-centre study.

As the study continues, our team remains committed to ensuring quality, compliance, and operational excellence, helping the sponsor establish their transformative robotic surgical platform in the UK market and ultimately improving patient outcomes through advanced surgical technology.

Our ongoing involvement ensures the study remains on schedule, compliant, and ready to deliver meaningful insights for the sponsor's UK and EU regulatory strategy.