Depending on your needs, NAMSA offers both paper-based and electronic data capture (EDC) platforms for comprehensive data management support.

In 2011, we partnered with the MedNet Solutions  and began offering the medical device industry’s premier technology platform for EDC: iMedNet. iMedNet’s proven, robust, and fully configurable eClinical solution provides easy-to-use features and is 21 CFR Part 11 compliant. The iMedNet EDC system provides sophisticated data management tools and complete study management functionality – everything needed for efficient and successful research initiatives.

No matter what platform you choose, we are skilled at building, managing, and maintaining databases for our clients. The following functionality and support services are available to support our clients’ clinical studies.

 

iMedNet Core Functionality

  • A Sponsor portal

iMedNet Tools

  • To-do lists
  • Patient record management
  • Comprehensive CRF history
  • Hover help
  • Conditional branching
  • Visit planner
  • Training center
  • Resource center

Clinical Trial Management System (CTMS) Tools

NAMSA also boasts one of the most robust CTMSs in the medical device industry. Our internal system—developed on the basis of over 20 years of running medical device trials—features the following custom tools and functionalities:

  • Tracking and management of regulatory documents
    • IRB approvals
    • Investigator CVs
    • Training records
    • Site contracts
    • Protocols
  • Action-item management
  • Investigator payments
  • Monitoring checklists and reports
  • Device accountability
  • Meeting minutes
  • Creating and editing sites
  • Creating and editing personnel
  • Site dashboard
  • Site enrollment
  • Site documents
  • Status
  • Data collection status
  • Global messaging

Data Management Tools

  • eMonitoring™
  • Unscheduled events
  • Deviation management
  • Adverse event (AE) tracking
  • Override report
  • Inactivation report
  • Withdrawal report
  • Datasets-on-Demand™ (DOD)
  • Audit functions
  • Form change log
  • Unlocked forms audit
  • IP address audit
  • Website sign-on
  • Comprehensive audit and reporting tools

Data Management Services

In addition to EDC and paper-based solutions, we offer full-service data management support through our team of in-house professional data managers and consultants who are cross-trained and integrated with our clinical teams.

Common Assignments

  • CRF development and design
  • Database development
  • Data entry
  • Query resolution
  • Data management reporting
  • Programming to support statisticians
  • Site management and payment
  • Monitoring support
  • Web-based and in-person training
  • Specification and implementation of payment rules
  • Data cleaning

Our objective is the timely within budget delivery of accurate and interpretable data from your clinical study.