Paladin Medical provides services at all levels of clinical study planning, management, and field monitoring. We ensure that clinical trials have clear objectives, with outcomes supporting regulatory submissions, marketing claims, and third party payer requirements. We work with the local regulatory staff, such as IRB coordinators and investigator’s staff, to make sure that all submission information, such as investigator brochures and case forms, are properly prepared and available for timely review.
Investigational Device Exemption (IDE) Regulations and Applications +
All studies of medical devices on human subjects are governed by IDE regulations. Before commencing trials, any significant risk study requires an IDE application and prior approval by FDA. Beyond the IDE regulations, medical device manufacturers must also meet the requirements of the local human subjects 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-qualify 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 and international 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
Clinical Trial Study Design +
A well-constructed IDE application begins with a sound protocol. Firms often become ensnarled with the protocol preferences of the primary investigator, and may have difficulty establishing a clinical protocol study plan that results in data worthy of submitting. Paladin Medical has the experience to work with all the stake holders in the process required to develop a suitable clinical trial plan. We can also help you conduct trials outside the US, and navigate conflicting requirements and different trial standards.
Monitoring and Management +
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, support staff questions file required reports. Paladin Medical frees up your company’s resources by handling these tasks.