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Clinical Research


Let our clinical research consultants partner with you to successfully navigate all phases of clinical research.

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Clinical Projects Per Year

100 %

Medical Device Focus


Clinical Trials Supported

The global medical device landscape is complex. Getting a new product or therapy approved requires compelling clinical evidence. At NAMSA, we know what you’re up against and understand how to set you up for success, which is why we offer expert medical device clinical research consulting services.

Our clinical trial consulting expertise spans every manner of technology, therapy, indication and geography. This broad range of experience allows us to successfully lead our clients through all phases of clinical research: from first-in-human to pivotal and post-market. NAMSA’s global footprint also provides clients direct access to local networks to conduct safe, effective and efficient clinical trials, which are optimized to achieve regulatory approval and continued innovation.


NAMSA Clinical Services

Biostatistics & Statistical Programming

NAMSA’s Biostatistics Team works in parallel with our Study Management and Data Management Teams to offer each client a custom-designed program that maximizes biostatistics efforts and outcomes. Leveraging NAMSA’s vast knowledge and expertise in medical devices, our Biostatisticians capture, analyze and present data from clinical trials to provide the clinical research services, support and evidence you need to be successful.

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 & Power Analysis
  • Data Analysis for Scientific Papers or Regulatory Submissions
  • Data Monitoring Committee (DMC)/ Data Safety Monitoring Board (DSMB) Membership & Support
  • Global Regulatory Authority Meetings & Conferences on Statistical Design & Data Analysis
  • Medical Device Data Analysis & Statistical Reports
  • Clinical Trial Protocols & Statistical Analysis Plans Preparation
  • Randomization Scheduling
  • Statistical Analysis Preparation: Programming & Validation for Dataset Creation, Tables, Figures & Listings
  • Targeted Biostatistics Consulting
Clinical Evidence & Post-Market Studies

Medical device Sponsors are intimately aware that regulatory approval can be meaningless without clinical evidence to back a product’s claims and reimbursement objectives. NAMSA offers a broad array of clinical evidence and post-market study support services to assist manufacturers to justify, bolster and differentiate product claims to clinicians, patients and payers.

NAMSA supports each client based on their unique clinical claims and objectives, taking into account desired timelines and budgets. Our most requested support options include:

  • FDA Condition of Approval Studies
  • Literature-Based Meta-Analysis
  • Post-Market Patient Registry Study
  • Randomized-Controlled, Multi-Center Clinical Trials
Clinical Study Management

NAMSA’s Clinical Research Team provides customized clinical study design and protocol development that balances the interests of multiple stakeholders. This is achieved by collaborating with our internal Regulatory, Reimbursement and Statistical Teams.

Our clinical trial research consulting teams are expert at advising on the necessity, implications and practicality of clinical study design factors, unlocking the full potential of trial protocol and ensuring that all stakeholder perspectives are properly addressed. Each study undergoes regularly scheduled reviews in which NAMSA’s Project Management Team and Clinical Study Managers scrutinize key factors such as quality, budget and timelines while also proactively addressing potential risks or roadblocks.

NAMSA is ISO 9001:2015 certified and adheres to applicable global regulations and standards for patient protection and clinical data integrity. We have well-established SOPs for the planning, initiation and conduct of studies. Our clinical trial research teams are committed to meticulous planning and communication to manage costs and accelerate timelines to move your device to the commercialization phase as efficiently as possible.

Some of NAMSA’s Clinical Study Design and Protocol services include:

  • Adaptive Study Design
  • Case Report Form (CRF) Design
  • Clinical Hypothesis Consultation
  • Cost Estimation
  • Draft IDE submission, including Protocol Summary
  • Endpoint Selection & Confirmation
  • Health Economics & Reimbursement Planning
  • Literature Review
  • Participation in Pre-IDE Interactions with FDA
  • Protocol Writing & Review
  • Randomization Scheduling
  • Resource Planning
  • Sample Size Calculations & Power Analysis
  • Statistical Analysis Plans for Clinical Trial Protocols
  • Submission of IDE to FDA
Clinical Trial Safety

NAMSA offers a full-service team of in-house medical monitors and MeDRA coders with expertise in clinical research to ensure your trial runs smoothly and efficiently. Our clinical trial research consultants are licensed Physicians who work closely with Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) members to ensure the protection of trial participants, while also advising Sponsors on the credibility and safety of trial results.

Some of NAMSA’s most common safety services include:

  • Review of each adverse event (AE) to determine whether it meets criteria for endpoint adjudication; additional assessment of AEs provided when recommended or required
  • Development of narratives for AEs that necessitate adjudication, and determination of when re-adjudication is required
  • Facilitation of meetings with CECs or DSMBs in which safety and efficacy data are reviewed for interim safety and efficacy analyses
Data Management and EDC

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.

Additionally, NAMSA offers various Electronic Data Capture (EDC) and data management tools to optimally achieve clinical data goals, including NAMSA’s proprietary Syncrony System. All EDC applications are 21 CFR Part 11 compliant and allow Sponsors to accurately track critical study areas in real-time. Ultimately, these intuitive systems increase the accuracy of collecting, tracking and storing clinical trial data.

Some of NAMSA’s EDC attributes include, but are not limited to:

  • Adjudication
  • Case Report Forms (CRFs)
  • ePRO
  • Inventory Management 
  • Payments
  • Randomization
  • Trial and Site Management

No matter the solution, our clinical trial research consulting team is relentlessly focused on delivering accurate and interpretable data—on time and on budget.

Field Clinical Engineering Staffing

NAMSA provides access to a team of credentialed, insured professional Field Clinical Engineers (FCEs) with significant research, industry and clinical experience within specific therapeutic areas and geographic locations. FCEs are skilled at securing data that is most likely to support regulatory and reimbursement goals, allowing Sponsors to not only reduce overall costs and timelines, but to also focus on more critical development tasks. They are ready to tackle all field clinical needs that your study may require, when and where you need them.

FCE benefits include:

  • Bi-directional clinical site and sponsor communication
  • Decades of hands-on clinical experience across numerous therapeutic areas
  • Expertise with site selection and development of efficient clinical processes
  • Knowledge of correct study management
  • Personal history of interacting with many Key Opinion Leaders (KOLs) and organizations
  • Team approach for seamless cross-coverage
Imaging Core Laboratory

With technology at its crux and a dedicated team of world-renowned physicians at the helm, NAMSA offers the highest quality Imaging Core Laboratory 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
Physicians and Institutions

NAMSA has several physicians on staff clinical, so we understand firsthand the clinical research challenges physicians and institutions can face. Our expert clinical research consultant team works closely with Clients to lessen their workload through full clinical study management—from concept to publication—while keeping stakeholders apprised of progress at all times.

By entrusting the management of your clinical study operations to us, you can be confident that your research objectives are met on time and within your budget. Because we fully understand the needs of the academic community and the intricacies of the clinical trial process, we deliver the precise services you need to generate the clinical evidence anticipated by you and your peers.

In addition, NAMSA works with independent physicians, collaborative groups, and consortia. We help academic societies produce controlled and real-world data to support the advancement of products and therapies.

Some of our real-world experience includes:

  • International registry for academic medical society of over ten thousand patients for Centers for Medicare and Medicaid (CMS) reporting
  • Coronary trial of 1200 patients in Europe and Asia
  • Core Laboratory for global collaboration of independent physicians for classification of endoleaks unique to endovascular aneurysm sealing
Safety Reporting & Clinical Events Committees

NAMSA provides expert support for Clinical Events Committees (CEC), Data Monitoring Committees and Data Safety Monitoring Boards (DMC/DSMB). NAMSA adheres to well-established processes for documenting and reporting Adverse Events (AEs) that may occur during investigational studies. AEs are reported using uniform guidelines, and in compliance with applicable regulatory requirements.

Common Tasks Include:

  • Committee Charter & Procedures
  • Committee Member Interviews & Recruitment
  • Meeting Scheduling, Facilitation, Recording Minutes
  • Negotiating Committee Member Agreements & Remuneration
  • Source Documentation, Adjudication Forms, Event Narratives
  • Writing & Distributing Follow-Up Reports