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NAMSA
Clinical Research

Comprehensive Services, customized approach

Let our experts partner with you to successfully navigate all phases of clinical research.
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500

Clinical Projects Per Year

100 %

Medical Device Focus

90 %+

Clinical Clients Recommending NAMSA

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.

Our clinical 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 support and evidence you need to be successful.

With an average of 15 years’ experience, each 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 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 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
Data Management

NAMSA offers a full range of 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 Case Report Form (CRF) 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, all of which are 21 CRF Part 11 compliant. These state-of-the-art programs allow Sponsors to accurately track critical study areas—from adjudication, ePRO, trial and site management, randomization, inventory management and other important trial attributes.

No matter the solution, our 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
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

Resources

Webinar
How to Manage Clinical Study Data During the COVID-19 Pandemic
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Webinar
EU MDR Part 1: Current Opportunities & Challenges with Clinical Data-A NAMSA Panel Discussion
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Webinar
EU MDR Part 2: How to Approach Clinical Evidence Requirements with Clinical Management & Biostatistics
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Literature
Clinical Research Services Brochure
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Publication
Medical Device Landscape Report: Trends and Challenges in Clinical Research Outsourcing
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