Medical Device and IVD Clinical Investigation Plan, Study Design and Protocol Development

Trust NAMSA to Develop a Robust Clinical Investigation Plan

Clean, valid data is essential for supporting a premarket submission or post-market compliance.  When a clinical study goes awry due to enrollment or data problems, it can often be traced back to poor study design. Carefully crafted clinical trial designs are vital for ensuring that study protocol supports collecting data in the right way. Spending time up front on study design and clearly defining endpoints and patient population paves the way to gather the scientific evidence you will need to prove the safety and efficacy of your device.

NAMSA is the largest clinical research organization dedicated to medical devices and IVDs. Every year we conduct hundreds of medical device clinical projects in a variety of therapeutic areas. We have particularly deep expertise in cardiology, vascular, orthopedics, neurovascular,  infectious disease, and wound care. Some of NAMSA’s clinical study design and protocol services include:

• Adaptive study design
• Case Report Form (CRF) design
• Clinical hypothesis consultation
• Cost estimation
• Draft IDE submission, including protocol summary
• Endpoint selection and confirmation
• Literature review
• Pre-IDE interactions with FDA
• Protocol writing and review
• Randomization scheduling
• Resource planning
• Sample size calculations and power analysis
• Statistical analysis plans for clinical trial protocols

The Importance of Trial Design and Planning

Trial design defines study objectives, endpoints, populations, prevalence, duration, randomization methods, sample sizes, data analysis methods and more. It forms the basis for investigator and regulator engagements.   Your Clinical Investigation Plan (CIP) is an important part of study design, aligning the design of your trial with your product’s regulatory and commercial strategy.  The CIP provides a detailed roadmap for investigators and research staff on how to conduct the trial and should follow Good Clinical Practice requirements as found in ISO 14155:2020. Your clinical trial synopsis will support the clinical investigation plan or protocol development by providing a summary of the main aspects of the CIP .

Factors That Impact Development of Your Clinical Study Protocol

NAMSA has worked on clinical research projects for a vast array of devices. Our expert team of clinical trial specialists will design a study that meets all relevant regulations and with the highest probability of success. While many factors are considered in study design and protocol development, some universal factors to consider include:

1. Device operation – How does your device work? The underlying scientific principles and mode of action play a big role in determining how your clinical study will be designed.
2. User skill and training required – How complex is your device to use? Some devices such as IVD’s can be used by several different people with varying skillsets and responsibilities and these factors need to be taken into account when writing the protocol for your study.  Others like a mitral valve replacement required the skilled hand of a surgeon.
3. Device novelty – Innovative technology often requires a learning curve. This can be especially true for implants that employ a new surgical technique for implantation. However, even trials for simpler technology require careful planning if they alter well-established methods of use.
4. Device usability – Users may interact with devices in ways unanticipated by the engineers who designed the device.  These so-called “human factors” must be taken into account when designing the study.