Pivotal Clinical Trials for Medical Devices

NAMSA Conducts Hundreds of Clinical Studies Each Year

At NAMSA, we support a wide range of medical device trials, with a particular focus on pivotal clinical trials. Each year, we conduct hundreds of studies, leveraging our comprehensive service offerings to meet the unique needs of our clients. Our partnership approach ensures that we provide the level of support you need, whether it’s targeted biostatistics, clinical strategy support, or full clinical trial management.

A partnership with NAMSA offers you access to medical device key opinion leaders and a team with hundreds of years of regulatory and clinical research expertise. Many of our associates are former FDA or Notified Body reviewers, bringing practical “real world” expertise to advise on your strategy and steer your clinical trial toward a success outcome.

Comprehensive Support for Pivotal Clinical Trials

We offer a variety of services to support your pivotal clinical trial, including:

• Site Management and Monitoring: Inclusive of risk-based monitoring to ensure compliance and efficiency
• Data Management: Ensuring accurate and reliable data collection and analysis
• EDC Database Development: Utilizing systems such as iMedNet, Medidata, Zelta, Marvin, and more
• Study Management: Handling all technical aspects of your trial
• Electronic Trial Master File (eTMF) Management: Using Veeva Vault for secure and efficient document management
• Project Management: Planning, coordinating, and executing all phases of your trial
• Local Submissions and Trial Registration: Managing regulatory submissions and trial registrations
• Statistical Analysis Plan: Including randomization and detailed statistical planning
• Synopsis and Protocol Development: Crafting comprehensive trial protocols
• FDA Pre-Submission Support: Assisting with early regulatory interactions
• IDE Submission Support: Guiding you through the Investigational Device Exemption process
• Medical Writing: Providing protocol writing, investigator brochures, IRB submissions, literature research, clinical study reports, and more

With our comprehensive service offering, NAMSA can partner with you in various ways to support your trial, from full trial management to augmenting your staffing.

Cost and Time Efficiency Through Expert Project and Study Management

We understand that cost and time efficiency are critical to the success of your pivotal clinical trials. By outsourcing your clinical trials to NAMSA, you can avoid the significant costs associated with hiring and training full-time staff for a single project. Our established processes and infrastructure lead to faster trial completion and reduced overall costs. By partnering with NAMSA, you can achieve your clinical milestones more quickly and cost-effectively.

We leverage our expert project and study management teams to manage your pivotal clinical trial. Our project management teams excel at planning, coordinating, and executing all phases of your study, working closely with you to develop a comprehensive project plan that aligns with your goals and timelines, while ensuring efficiency throughout the process. Meanwhile, our study management team handles all aspects of patient recruitment, site management, and regulatory compliance so your trial meets all necessary standards and progresses smoothly.

By combining the strategic oversight of our project managers with the technical expertise of our study managers, NAMSA provides a comprehensive approach to clinical trial management, identifying and implementing efficiencies at every stage. This dual-layered structure ensures meticulous handling of all technical aspects, minimizing delays and reducing costs.

Site Management Risk Mitigation for Medical Device Pivotal Trials

With our extensive experience, we can anticipate and address potential issues before they become significant problems. Our proactive approach to risk management helps minimize risks and ensures the success of your clinical trial. We implement rigorous quality assurance processes to maintain the highest standards of safety and compliance. Examples of techniques we use to streamline your trial include:

• Site Selection and Qualification: Meticulously selecting and qualifying clinical trial sites based on their capabilities, past performance, and compliance with regulatory standards.
• Training and Support: Providing comprehensive training and ongoing support to site staff to ensure they are fully prepared to conduct the trial according to the protocol.
• Monitoring and Auditing: Conducting regular site visits and remote monitoring to ensure compliance with the trial protocol and regulatory standards.
• Communication and Coordination: Maintaining open lines of communication with all trial sites, providing clear guidance and timely updates.
• Risk-Based Monitoring: Employing a risk-based monitoring approach, focusing resources on the most critical aspects of the trial.
• Data Management and Quality Control: Ensuring that all data collected from trial sites is accurate, complete, and compliant with regulatory standards.

By leveraging these strategies, we effectively mitigate risks associated with site management, ensuring the smooth and successful execution of your pivotal clinical trials. Trust NAMSA to provide the expertise and support needed to navigate the complexities of clinical research and achieve your trial objectives.

Comprehensive Post-Study Support

At NAMSA, our commitment to your success extends beyond the completion of your clinical trial. We offer a range of post-study support services to ensure a smooth transition to market and ongoing compliance. Our services include:

• Regulatory submission assistance
• Post-market monitoring
• Post-approval studies
• EU PMCF (Post-Market Clinical Follow-up)
• Annual reporting for IDE studies and Class III devices
• Reimbursement CED (Coverage with Evidence Development)
• HEOR (Health Economics and Outcomes Research) studies
• Post-market registry support
• Manuscript and publication assistance
• Instructions for Use development

Trust NAMSA to support you at every stage of your medical device’s lifecycle.