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Clinical Study Design

The times they are a-changin'. Clinical studies today should be designed and managed based on regulatory and insurance reimbursement requirements, not simply upon the old pharmaceutical models of clinical study design on which we have been trained. Nowhere is this more true than in the medical device and combination product world. For a small to medium-sized company, the cost of this clinical evidence can be significant.

In the United States, the FDA may request this evidence as part of a 510(k) submission and requires it in a Premarket Approval application (PMA). In the EU, the need for clinical evidence may arise during the CE marking process as a result of a lack of clinical evidence of safety and performance. Based upon how the need arises, clinical study designs can vary widely which makes it important to always keep the ultimate purpose of the study in mind.

It's easy to see when you have a brand new medical product treating a condition that has yet to have a successful treatment that a classic phased approach to clinical studies is necessary during product development. However, if you have a novel technology embedded within your medical device or combination product, and simply need to demonstrate that the new technology continues to deliver the same or an improved therapeutic effect - you should not try to "force fit" this type of study design to meet a typical phase III pharmaceutical model.

Our consultants are experts at thinking "outside the box" to develop protocol designs and investigational plans that comply with Good Clinical Practices (GCP), FDA guidances, and ISO 14155 while focusing on the objective at hand. For over twenty-five years we have worked with clinicians and clients to design and manage studies ranging from small, fifty-patient studies aiming to demonstrate that a medical device modification has had no significant impact on safety and performance, to large multisite clinical studies spanning multiple countries whose aim was to demonstrate that a medical device with a new intended use safely and effectively achieved its intended outcome.

We work with a lot of startups and know that these smaller organizations often don't have the resources to conduct a clinical trial or study of their own. To combat this, RQMIS provides support in all of the activities required to design, gain regulatory approval, and manage a clinical trial. We can also assist with individual tasks related to clinical studies including:

  • Study Design, Implementation, and Management
  • Project Management (including Biometrics Project Management)
  • Startup Activities (including regulatory submissions)
  • Site Selection and Management
  • Clinical and Bioresearch Monitoring
  • Investigator Training
  • Onsite Technical Support
  • Safety Reporting
  • DSMB/CEC Management and Functional Sourcing

We also offer bioresearch monitoring services, including an independent audit of your clinical study to ensure compliance with GCP, regulatory requirements, and confirmation of patient protection, and data integrity. Other bioresearch services include:

  • Informed consent
  • Protocol Compliance
  • IRB reporting
  • Disclosure and proper documentation of adverse events at the clinical site
  • Drug/device accountability
  • Warning Letters

Ready to get started on your clinical trials?

We'll help you design, implement and manage the studies. Give us a call today at (978) 358-7307, or just click here:

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