NAMSA provides comprehensive quality systems consulting services in essential aspects of clinical research and statistical support. Our clinical and statistical expertise spans all manner of technologies, therapies, indications, and business strategies.

Clinical Design

If your clinical research protocol is not yet developed, or is partially developed, we can assist in its completion. To be of full service to you, we require a clear understanding of your clinical endpoints, marketing claims, regulatory objectives, and reimbursement and marketing strategies. This comprehensive view enables the best possible clinical design to support your product’s commercialization.

Common Services Related to Study Design

  • Sample size calculations and power analysis
  • Literature search and summary
  • Randomization scheduling
  • Statistical and analysis planning for trial protocols
  • Protocol writing or review
  • Preparation of draft IDE submissions, including protocol summary
  • Participation in pre-IDE interactions with FDA
  • Submission of IDE to FDA

Clinical Trial Conduct

Clinical trials are the costliest phase of development, due to delays and false starts. Our approach to minimizing risk is to assign highly experienced, highly competent clinical research professionals who have supported many medical device trials during their careers. Our Project Managers, CRAs, and Clinical Monitors know GCP, ICH, and FDA standards of data integrity, patient protection, and regulation.

NAMSA’s support of clinical trials spans study startup, ongoing study activities, and the reporting phase through study closeout.

  • Biostatistics
  • Data management and database
  • Site qualification, selection, and initiation
  • Site management
  • Study management and administration
  • Clinical monitoring
  • SAE reporting
  • Study closeout
  • Analysis
  • Final clinical report

Within each function, we follow comprehensive task procedures developed from the experience of having supported hundreds of medical device clinical trials. Whether following your SOPs or our own, we’re comfortable following the applicable procedures.

Clinical Monitoring

NAMSA is widely recognized for high-quality clinical monitoring services for medical device studies.

Our clinical monitors double as CRAs, meaning that they understand the larger context of the monitoring effort.
When authorized, our clinical monitors are capable of resolving discrepancies on site.
NAMSA’s goal is to elevate site compliance, not to assign fault.
Our clinical research monitors average 10.5 years of experience in the medical device industry, and 3.9 years of tenure with NAMSA.
We directly employ highly professional clinical monitors who are skilled at helping clinical sites yield valid, FDA-acceptable clinical data. Our monitors are clinical research professionals who understand both GCP requirements and the entire clinical continuum from sponsor, site, and FDA perspectives. Their ultimate goal is to elevate site performance and morale, not to assign fault or blame. Our monitors also remain in close communication with our data management and statistical support staff to identify and head off potential problems.

Statistical Design and Analysis

NAMSA employs a highly experienced cadre of medical device-focused professional biostatisticians. Our team members average over 20 years each of experience in biostatistics. Our services include:

  • Statistical and analysis planning for trial protocols
  • Sample size calculations for clinical trials
  • Participation in FDA meetings and teleconferences focusing on statistical design or data analyses
  • Collaboration with medical experts to extract meaningful clinical interpretations from data analyses for use in scientific papers or regulatory submissions
  • Randomization scheduling
  • Statistical analysis and preparation of statistical sections for reports, such as the creation and validation of datasets, tables, and listings for clinical research trials
  • Audits of project management, data management, and statistical group
  • Report writing for regulatory submissions or other reporting requirements
  • Audit preparation and support for bioresearch monitoring (BIMO)