Clinical Trial Protocol Design2021-05-18T08:22:33-04:00

Clinical Trial Protocol Design

  • Clinical evidence demonstrating safety and efficacy is not only critical for meeting regulatory requirements (through benefit-risk assessment) to be able to market your device, it’s valuable to clinicians and patients in understanding the preferred use of your device, health systems and physicians in making purchasing decisions, and payers in evaluating product value and making reimbursement decisions.

  • Your clinical trial design can be maximized to serve a dual market access purpose, allowing you to generate evidence for multiple stakeholders.

  • Before you can conduct your study and begin generating evidence, your clinical protocol must be approved by regulators and institutional review boards. Your protocol should detail your study objective(s), rationale for conducting the study, study design, methodology, key definitions of primary events, situations requiring data to be excluded, data management and analysis techniques, and more.

  • The cost to conduct a pivotal study is typically in the millions, and depending on the risk stratification (i.e. class designation) of your device, it may not be necessary to conduct a clinical trial for market release in the US. Class I devices are typically exempt from needing to conduct clinical studies, as well as many class II devices. In the EU, however, class I devices required clinical evidence of safety and efficacy.

  • PMA pathways (for class III devices) typically require manufacturers to provide data from a pivotal study, while 510(k) pathways only require evidence of equivalency to a predicate device.

  • Study success does not always imply device approval, and study findings often influence device modifications.

  • From simpler, single-arm trial designs to factorial trials, our experts can help you select the most appropriate study design to generate the evidence your stakeholders need.

  • By carefully adding economic endpoints to your planned clinical protocol, our experts can maximize your pre-approval clinical studies, collecting crucial payer- and provider-focused data alongside safety and efficacy data in a faster, more cost-effective way. If your studies are already underway and don’t include economic data, we can implement several possible strategies to collect this data.

  • With a collective 20+ years worth of successful FDA and IRB submissions, we can help develop your clinical protocol and handle IRB submissions.


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Maximize Your Pre-Approval Clinical Studies

Contact our experts for protocol development, design and analysis of clinical trials that serve a dual market access purpose.

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