Case Study

510(k) Study Of Respiratory Diagnostic

Source: Health Decisions Inc.
petri dish sample laboratory

A sponsor had to conclude discussions with regulators and complete a variety of logistical arrangements and was left with an unusually brief period between study startup and the target period for sample collection – fall flu season. In addition, there is always the risk that a chance season of low incidence of respiratory infections will cause sample collection to lag behind projections.

Read more about the strategies for risk management and mitigation were among those that Health Decisions utilized in this study to overcome the following challenges:

  • Collecting samples rapidly during a flu season of approximately 3 months despite condensed startup timelines
  • Ensuring effective sample tracking to prevent loss of any samples
  • Ensuring sample integrity through proper sample collection and shipment
  • Ensuring effective cohort management to meet goals for demographic diversity