Doing Diagnostics Right by Redefining Clinical Studies

We streamline and expedite the IVD clinical research process, leveraging our regulatory expertise and curated site network to help bring your IVD test to market faster and more efficiently.

Our Services

Design

  • Regulatory Strategy
  • Protocol Design & Development
  • Study Documents
  • EDC & Data Dashboard
  • CTMS
  • Data Management Plan

Start Up

  • Site Selection
  • Contract & Budget Negotiation
  • Supply Management
  • Enrollment Packet & Kit
  • Multi-Center & Site Level IRB
    Submission
  • Site Initiation

Study

  • Site Monitoring Visits
  • Remote Monitoring
  • TMF Management
  • Site Payments
  • Query Resolution
  • Event/AE Tracking

Close-Out

  • Site Close-Out Visits
  • Data Review and Cleaning

Agency Submission

  • Clinical Study Report
  • Regulatory Meetings
  • Audit Preparation

Transfer

  • TMF Transfer