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.
Routine biocompatibility testing according to ISO 10993 has become one of the most commonly conducted preclinical studies and many of those studies require animal subjects. FDA and international regulatory agencies are emphasizing the development of a Biological Risk Assessment prior to the conduct of standardized testing. FDA has issued numerous guidance documents concerning the level of biocompatibility testing for certain products, how to interpret the latest ISO 10993 and its various parts, and specialty guidance documents that indicate what type of testing is recommended for a particular type of product. Paladin Medical® will work 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 tested before launching very expensive studies. Refer to Biomaterials in Specialty Services
Animal functional studies are those intended to demonstrate the safety and performance of the device, including integration of biomaterials and restoration of function. These require careful planning, oversight, and reporting. The study protocol must produce the outputs that support the submission. The most critical studies are those which are required prior to “first in man” clinical studies. Standardized performance studies described by standards and FDA guidance documents are just as critical to get right the first time. We provide standardized templates to help you assure critical content, help finalize study protocols and assure study archives. We often recommend a pre-sub meeting with FDA prior to launching pivotal animal trials. Refer to Submissions and Good Laboratory Practices in SPECIALTY SERVICES
We ensure that clinical trials have clear objectives, with outcomes supporting regulatory submissions, marketing claims, and third-party payer requirements. We work with the IRB coordinators and investigator’s staff, to make sure that all study deliverables, such as investigator brochures and case forms, are properly prepared and available for timely review. Our specialty is “First in Man” trials 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
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