Preclinical / Clinical
Assure your protocols will yield the evidence you need to support your submission.
Pre-Clinical Study Design
Pre-clinical in-vitro and in-vivo (animal) studies must produce results that support product approval submissions and design validation. Animal ethics boards must approve and monitor animal trials. Our expertise in matching regulatory requirements and preclinical study plans makes Paladin Medical® an invaluable resource to your firm.
Biocompatibility testing according to ISO 10993 is expensive and time consuming. Even though all regulatory authorities recognize this standard, it is not interpreted the same. In the past, FDA and international regulatory agencies emphasized a biological risk assessment prior to the conduct of standardized testing. In our most recent experience FDA wants to see test data of your own, FINAL device (post sterilization, post-packaging, post-manufacturing) and for FDA applications you must follow their guidance document Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
Paladin Medical® will collaborate with your team, your lab, and the FDA to assure you conduct only the tests necessary, that your product samples are prepared properly and that you have a sound description of the biomaterials to be evaluated before launching very expensive studies.See Biomaterials in Strategic Services
Pre-clinical (animal usually) studies which are designed to evaluate the safety and performance of the device in a simulated use biological model, including testing for the integration of biomaterials and restoration of function require extensive planning and a full team of knowledgeable individuals to produce results that support your submission. These “safety” studies may be required to support a “first in man” clinical study. With our experience Paladin Medical can help you locate the best laboratory and organize the optimum study and present your plans to FDA in a “pre-sub” if appropriate. We can serve as the QAU if the laboratory does not have such services and provide compensating regulatory assistance if the laboratory is not GLP certified. See Good Laboratory Practices in Strategic Services
Clinical Trials
Academic clinical studies are seldom managed with the rigor required of clinical trials designed to support a premarket application. We ensure that clinical trials have clear objectives, with outcomes supporting regulatory submissions, marketing claims, and third-party payer requirements. Our specialty is “First in Man” trial that can make or break your future regulatory pathway.
Clinical Trial Monitoring and Management Clinical study planning, management, and field monitoring requires trained employees and coordination between the investigators, the sponsor, the IRB and FDA. Paladin Medical® provides ongoing support for study management. We can provide study monitoring and data audits. We can ensure sites are trained, test product is delivered, and required case forms and reports are completed.
Clinical Trial Study Design
A well-constructed clinical study must have a sound protocol to deliver the evidence the company needs for submission and yet assures patient safety. Clinical trials in support of new medical device applications have different objectives than do academic research trials. Planning your study to meet your objectives is critical. Firms often become ensnarled by research preferences of a primary investigator and may have difficulty establishing a clinical study plan that results in data suitable for FDA submission. Paladin Medical® has the experience to work with all the stake holders in the process required to develop a suitable clinical trial plan.
Human Factors and Usability Trials typically involve volunteer users and blinded studies to evaluate the user’s ability to follow instructions, apply the device properly and address warnings and error codes. Please consult Human Factors and Usability Studies in SPECIALTY SERVICES
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Investigational Device Exemption (IDE) Regulations and Applications
All studies of medical devices on human subjects are governed by Investigational Device Regulations. Clinical trials of an unapproved new medical device can be either Non-significant Risk (NSR) or Significant Risk and this determination is made not only on the type of device but also on the type of study you plan. Any significant risk study requires an IDE application and prior approval of the study and the basic safety of the device by FDA. A non-significant risk study does not require an IDE application but the device integrity at the time of the study must be under Design Control and Review quality regulations. Read more in Design Control and Review. We help you to determine and document if your study may be non-significant risk and integrate this rational into the Risk Analysis requirements of your Design Control and Review documentation. We can help you understand the issues associated with your protocol design, case form and data collection, electronic data collection systems and FDA reporting of results.
Beyond the IDE regulations, medical device manufacturers must also meet the requirements of the local human subject committees in each clinical or hospital (IRB). Paladin Medical® offers assistance with:
- Design of clinical trials with clear objectives and outcomes supporting regulatory submissions
- Pre-qualification of investigators and study sites
- Informed consent forms, case reports and Investigator’s manuals
- Support and training of study sites
- Packaging and labeling that meet IDE regulations
- Product tracking to study sites and product use auditing
- Device retrieval safeguards and analysis
- Electronic data capture with internet access
- Sample size determination and statistical data analysis
- Compliance with IDE regulations and reporting requirements
- Clinical trial management and monitoring
- Clinical trial report development
- Sourcing investigators, laboratories, and testing services
