Clinical data is the gateway to achieving market access and market adoption for medical device and drug innovations.

With increasing complexities and costs associated with leading a biotech organization, solid clinical strategy and accurate regulatory plans have become the key players to realizing such success.

The goal for startups, small, or emerging biotech companies is to get it right the first time to avoid sacrificing funds, time to market, and credibility within industry.

Recommendations:

Do the “right” study: Design the protocol with endpoints that will unambiguously target the objective/hypothesis/purpose for the investigational product. Refrain from the cut and paste method. One size no longer fits all.

Do the study “right”: Align the study execution with ICH-GCP. Use ISO 14155 for medical device investigations. The FDA advises these guidelines and conducts inspections accordingly. This avoids questionable data quality.

Embrace patient centricity: No device or drug trial can work without patients. Leverage a clinical diversity plan to support your enrollment targets. Use patient-friendly informed consent forms and recruitment methods to foster comfortability and trust with subjects. This helps with patient retention, thus stronger real-world outcomes.

Bottomline:

Invest in the success of your company and product viability by taking a moment to get the scientific rigor and operational structure right, the first time. It is also prudent to evaluate your ongoing plans.