Executing Clinical Trials for Medical Devices

Clinical Trial Data Management

Bringing a new medical device or In Vitro Diagnostic (IVD) to market is a huge investment and much of the expense comes from gathering clinical data. The success of your regulatory submission is highly dependent on the quality and accuracy of your trial data. NAMSA can help ensure that your clinical investigations meet ISO 14155, 21 CFR Part 11, and other applicable regulations for data completeness, accuracy, and security.

NAMSA offers a full range of clinical research consulting solutions for comprehensive data management and support, delivered by our experienced clinical data managers and clinical database developers. These team members, cross-trained and integrated with our clinical study management and biostatistics teams, provide services ranging from design and database development to data cleaning and monitoring support.

Clinical Trial Biostatistics

With an average of 20 years of experience, each clinical research consulting team member is 100% medical device-focused and understands the nuances and requirements of medical device statistics and data and how to deliver a custom-designed program that maximizes biostatistics efforts and outcomes. Some of NAMSA’s biostatistics and statistical programming solutions include:

• Adaptive study design
• Clinical study design: endpoint selection, sample size calculations and power analysis
• Data analysis for scientific papers or regulatory submissions
• Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) membership and support
• Global regulatory authority meetings and conferences on statistical design and data analysis
• Medical device data analysis and statistical reports
• Clinical trial protocols and statistical analysis plans preparation
• Randomization scheduling
• Statistical analysis preparation: programming and validation for dataset creation, tables, figures & listings
• Targeted biostatistics consulting

Clinical Data Safety and Reporting

NAMSA excels in Medical Device Safety Management and Reporting, offering comprehensive services led by a team of world-renowned physicians. Their end-to-end solutions include Medical Monitoring, Clinical Events Committees, Data and Safety Monitoring Board services, Adverse Event Reporting, and more. With a focus on various therapeutic areas, NAMSA’s highly qualified professionals ensure high-quality safety assessments. Their proprietary system customizes data collection and reporting, maintaining a proven track record of successful study completions.

Real-time data monitoring is a key feature, allowing for quick identification and action on potential safety concerns. NAMSA’s customizable platform manages and tracks adverse events, supporting ongoing reviews and facilitating Clinical Events Committee work. Their centralized platform enhances data organization and analysis, ensuring secure data storage. From start-up to closeout, NAMSA’s safety management and reporting process guarantees meticulous handling of trials, delivering accurate and timely safety data.

Imaging Core Lab Services

With technology at its crux and a dedicated team of world-renowned physicians at the helm, NAMSA offers the highest quality Imaging Core Laboratory (ICL) services in the CRO industry. Our expert imaging reviewers ensure quality and accuracy of image interpretation and analyses, and our highly efficient processes leave little for the Sponsors to manage.

Benefits of NAMSA’s Imaging Core Laboratory include:

• End-to-end service from image transfer and database set-up to site training on image acquisition and transfer
• Study protocol review for imaging endpoints
• Seamless integration and leverage of systems across NAMSA
• Transparency at every step and real-time client access to data
• Industry-best image reviews and turnaround times

With zero FDA audit findings and ISO 9001:2015 accreditation our imaging core laboratory has reviewed over 12,000 images and supporting over 40 PMA approvals for the FDA. Here are some examples of the types of image expertise our team can support:

• Computed Tomography (CT) Scans
• Magnetic Resonance Imaging (MRI)
• Angiography
• Intravascular Imaging System (IVUS)
• Optical Coherence Tomography (OCT)
• X-ray
• Ultrasound
• Echocardiogram
• And more

Medical Writing Services

NAMSA provides a wide range of specialized clinical and regulatory medical writing, manuscript submission, and evidence communication services. Our world-class team of medical writers is expert at identifying, organizing, interpreting, and presenting clinical data accurately and professionally for submission to various regulatory bodies.
Working in collaboration with our US and EU regulatory teams, we have extensive experience preparing:

• Clinical Evaluation Reports and Plans (CER and CEP)
• Performance Evaluation Reports and Plans (PER and PEP)
• Clinical Literature Reviews
• Periodic Safety Update Reports (PSUR)
• Post Market Surveillance Reports (PMSR)
• Summaries of Safety and Clinical Performance (SSCP)
• Clinical Study Protocols
• Clinical Study Reports (CSR)

Clinical Outsourcing

The clinical stage of your product development life cycle is arguably the most important on your road to regulatory approval. Even small mistakes early in your clinical research have severe regulatory consequences as endpoints are not met. These mistakes can delay your time to market and cost your company millions. When you work with NAMSA, you are making an investment in derisking your path to premarket approval. With NAMSA as your clinical trials outsourcing partner, you are getting access to the deepest team of clinical subject matter experts, all of whom focus entirely on medical devices and IVDs.

Clinical Trial Rescue Studies

When clinical trials begin to falter, medical device Sponsors face serious setbacks such as delayed timelines, budget overruns, and compromised data integrity—often due to poor site engagement, inadequate monitoring, and recruitment challenges. NAMSA addresses these issues through a strategic, hands-on approach to clinical trial rescue studies. By conducting thorough diagnostics, performing gap analyses, and re-engaging sites with clear communication, NAMSA restores momentum and compliance. Their experienced teams build trust with investigators, creatively solve enrollment issues, and maintain close collaboration with sponsors to not only rescue struggling studies but rebuild them stronger—earning repeat business and trust from clients who value their leadership and results-driven execution.