Clinical Affairs
A strong clinical strategy can help you bring your medical device to market faster and support your unique claims with solid clinical evidence.
Clinical evaluation is a critical part of the regulatory pathway for new medical devices in the United States and European Union. As a regulatory and clinical consultant, we can help you develop a clinical strategy that ensures your proposed clinical plan meets all regulatory requirements.
BioVision's experts have a deep understanding of medical device development processes and can help you identify the correct regulatory requirements, develop the appropriate research questions, and create a clinical strategy that gives you a competitive advantage by supporting your unique claims with solid clinical evidence.
A professional clinical strategy meets the following requirements:
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It identifies the specific regulatory requirements that must be addressed.
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It connects to the risk management activities and plan.
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It is relevant to the clinical claims that are being made.
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It verifies the need to collect (additional) clinical data.
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It addresses the relevant clinical research questions.
First-in-human trials
First-in-human trials refer to clinical trials that involve testing a new medical device for the first time in human subjects. These trials are typically conducted after the device has gone through preclinical testing, such as laboratory and animal studies, to establish its safety and efficacy.
The primary goal of first-in-human trials for medical devices is to evaluate the safety of the device in humans and to identify any potential side effects or risks. The trials may also aim to determine the appropriate dosage, optimal delivery method, and overall performance of the device.
During the trial, the medical device is tested on a small group of volunteers who are closely monitored by healthcare professionals.
If the device proves to be safe and effective in the first-in-human trial, it may proceed to subsequent clinical trials to establish its efficacy and to further assess its safety in larger groups of patients.
Overall, first-in-human trials play a crucial role in the development of new medical devices, as they provide valuable insights into the safety and effectiveness of the device before it is made available to a wider patient population.
Gathering Sufficient Clinical Evidence
When developing a medical device, you need to gather sufficient clinical evidence to support the safety and performance of your device. This evidence can come from a variety of sources, including compliance with product standards, verification testing, literature reviews, and clinical studies.
A clinical strategy is a plan for how you will gather the necessary clinical evidence. We can help you develop a clinical strategy that is tailored to your specific device and the regulatory requirements in your region.
Your clinical strategy will evolve as your device develops. As you make design decisions, we will work with you to ensure that your clinical strategy remains aligned with your risk management plan and your intended claims.
We have experience developing clinical strategies for all types of medical devices, from Class I to Class III. We have worked with startups and multinational companies alike. No matter where you are in the development process, we can help you develop a clinical strategy that will support your success.
• Design and development: The device must be designed and developed in accordance with good manufacturing practice (GMP) standards. This includes developing a detailed design plan, performing simulations and testing, an manufacturing prototypes.
• Animal testing: Animal testing is typically required to assess the safety of the device in a living organism.
The type and extent of animal testing will vary depending on the device and the regulatory requirements.
• In vitro testing: In vitro testing is used to assess the safety and performance of the device in a laboratory setting. This type of testing can be used to assess the device's biocompatibility, functionality, and potential for toxicity.
• Literature review: A literature review should be conducted to identify any relevant studies that have been conducted on the device or similar devices. This information can be used to support the safety and efficacy of the device.
• Risk assessment: A risk assessment should be conducted to identify and assess the potential risks associated with the device. This assessment should be used to develop mitigation strategies to reduce the risks to an acceptable level.
• Manufacturing and quality control: The manufacturing process for the device must be developed and qualified to ensure that the device is manufactured consistently and meets the required quality standards.
• Labeling: The device must be labeled with appropriate warnings and instructions for use.
Pre-Clinical activities
The pre-clinical activities that are required for approving a medical device to participate in a first in human clinical study (FIH) vary depending on the type of device and the regulatory requirements of the country where the study will be conducted. However, some common pre-clinical activities include:
• Design and development: The device must be designed and developed in accordance with good manufacturing practice (GMP) standards. This includes developing a detailed design plan, performing simulations and testing, and manufacturing prototypes.
• Animal testing: Animal testing is typically required to assess the safety of the device in a living organism. The type and extent of animal testing will vary depending on the device and the regulatory requirements.
• In vitro testing: In vitro testing is used to assess the safety and performance of the device in a laboratory setting. This type of testing can be used to assess the device's biocompatibility, functionality, and potential for toxicity.
• Literature review: A literature review should be conducted to identify any relevant studies that have been conducted on the device or similar devices. This information can be used to support the safety and efficacy of the device.
• Risk assessment: A risk assessment should be conducted to identify and assess the potential risks associated with the device. This assessment should be used to develop mitigation strategies to reduce the risks to an acceptable level.
• Manufacturing and quality control: The manufacturing process for the device must be developed and qualified to ensure that the device is manufactured consistently and meets the required quality standards.
• Labeling: The device must be labeled with appropriate warnings and instructions for use.
Data management services
Data management services in clinical trials for medical devices involve a range of activities that are aimed at ensuring that the data collected during the trial is accurate, reliable, and of high quality. These services include:
1. Protocol development: Developing a comprehensive protocol that outlines the objectives, design, and methods of the trial. This protocol should also include details on the data management plan, including how data will be collected, stored, and analyzed.
2. Case report form (CRF) design: Developing a CRF that captures all the necessary data points for the trial. This includes demographic information, medical history, adverse events, and efficacy endpoints.
3. Data collection: Collecting data from multiple sources, including the CRF, electronic health records, and laboratory reports. This data is typically collected in real-time and stored in a secure database.
4. Data cleaning: Cleaning and validating the data to ensure accuracy and completeness. This includes identifying and resolving any data discrepancies or errors.
5. Data analysis: Analyzing the data to identify any trends or patterns, and to determine the safety and efficacy of the medical device.
6. Data monitoring: Monitoring the data throughout the trial to ensure that it is being collected and managed according to the protocol.
7. Database management: Managing the database that stores the trial data, including ensuring that it is secure, backed up, and accessible only to authorized personnel.
8. Regulatory compliance: Ensuring that the trial data is compliant with all relevant regulatory requirements, including those set forth by the FDA or other regulatory bodies.
9. Overall, data management services in clinical trials for medical devices are essential to ensuring that the trial data is accurate, reliable, and of high quality, which is crucial for obtaining regulatory approval and bringing new medical devices to market.