Case Study

Establishing Intelligent Clinical Regulatory Strategy Scenarios

Background

Clinlogix was asked to provide diverse clinical regulatory strategy scenarios to determine where a medical device start-up (“the Company”) could conduct their clinical studies for their investigational Class III cardiovascular implant.

The Challenge

The medical device start-up´s top priority was to obtain First-in-Human (FIH) clinical data, which would serve as evidence to potential investors as well as regulators that the implant was safe and had market potential. The FIH clinical data would then be used to drive their next funding series rounds.  Based upon the Company’s analysis, the United States was their largest global market opportunity and Germany was their largest European market opportunity.

The Company was faced with two critical questions:

  1. Where should they conduct their clinical studies in order to strategically optimize clinical data and;
  2. What type of investigations where available in order to achieve their objectives?

Without clear and knowledgeable answers to these questions the Company would be at risk for wasting time and invested capital.

The Clinlogix Solution

Clinlogix was appointed as the CRO for this clinical regulatory strategic consulting due to their comprehensive clinical strategy experience, successful track record, accessible local-based regional offices, and extensive global network.

The Clinical Regulatory Strategy team began the project by performing a clinical strategy assessment overview with the Company to narrow down potential geographic regions and nations.

The Clinical Strategy Assessment Overview included in-depth information on:

  • Key Opinion Leaders (KOLs)
  • Clinical Sites of Excellence
  • Clinical Practices
  • Patient Population Rates
  • Patient Follow-up Rates
  • Investigation Types
  • Legal Developments
  • Clinical Study Authorization Process and Timelines
  • Reimbursement Analysis
  • Cost Analysis

An analysis of the clinical strategy assessment overview provided three different strategy scenarios:

Scenario 1: US EFS rolling into the US IDE-PMA Study
Scenario 2: Compassionate Use Cases in Denmark rolling into the German EU CE Mark Study
Scenario 3: FIH Colombia study rolling into the German EU CE Mark Study

Conclusion

Creating and choosing the best clinical regulatory strategy is challenging for both the sponsor and the CRO, as there are no textbook answers. This particular project presented a fascinating opportunity to illustrate how the EU legal developments (i.e., MDR) impacted the decision process.

With the help of the highly experienced Clinical Regulatory team at Clinlogix and their extensive global network, the Company was able to:

  • Choose the best clinical regulatory strategy which fit their needs for an innovative regulatory environment that is reliable, predictable, collaborative, and responsive.
  • Reduce the time and cost to complete the FIH study.
  • Achieve clinical study milestones through experience-based organisation and planning.
  • Accelerate turnaround of scientific publications and scientific podium presentations.
  • Increase efficiency due to Clinlogix’s privileged and long-term relationships with hospitals and KOLs.