5 steps for a successful clinical investigation
Setting up a clinical investigation for a medical device requires careful planning and a thorough understanding of regulatory demands. Follow these five steps to ensure your project starts – and stays – on the right path from the very beginning.
A clinical investigation (also referred to as a clinical study or clinical trial) is defined as a systematic investigation in one or more human subjects, undertaken to assess the clinical performance, effectiveness, or safety of a medical device. The general requirements for good clinical practice in clinical studies of medical devices are specified in the ISO 14155:2020 standard.
Conducting clinical investigations is mandatory for all high-risk or innovative medical devices. However, understanding the complex requirements of clinical studies can often be time-consuming and challenging for medical device start-ups, R2B teams, or any newcomers in the field.
To learn the basics of clinical investigations, join now our free "Clinical investigations 101" course.
We sat down with our experts to compile a 5-step checklist to help you get started with your first clinical study:
1. Identify the regulatory requirements of your medical device
What kind of product are you developing? Some medical devices only require a clinical evaluation to safely enter the market, while others must undergo the more demanding and highly regulated process of clinical investigations. Many kinds of medical devices from high-risk implantables to software can require clinical investigations under European European Union Medical Device Regulation (MDR).
To avoid delays in bringing your product to market, it’s crucial to know what kind of clinical investigation or evaluation is required from your device. You can find detailed information about medical device classification in Article 51 of the MDR.
2. Plan and schedule your clinical study carefully
One of the cornerstones of a clinical study is a comprehensive project plan. This document includes elements such as risk assessment, goals, and a detailed action plan for achieving your project’s objectives. You don’t have to handle all of this on your own – our experts are here to assist you
3. Think about your budget
Many variables influence the cost of clinical investigations, ranging from the therapeutic area to compliance standards and the number of study centers required for your project. For newcomers to the field, setting an accurate budget can be extremely challenging. That’s why our experts are always ready to help you define a realistic budget that covers all aspects of your project.
4. Make risk management a top priority
Unlike clinical evaluations, clinical investigations involve human subjects, placing greater emphasis on patient safety. The safety processes are based on device risk management, and clinical risks must be documented in the risk file. No matter the type of medical device, safety should always be the primary concern in every clinical investigation.
5. Speed up the process with a CRO
The management of a clinical investigation requires expertise from various professionals and strict adherence to regulatory standards. By partnering with an experienced CRO, you can streamline the process, meet all regulatory requirements, and ensure a faster and more cost-effective path to market.
How to determine the degree of outsourcing for your clinical study? What you have to have in place before contacting a CRO? Find the answers on our free online course, Clinical Studies 101, designed for anyone preparing for their first clinical study!
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