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 submittable data. 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.
Clinical Study Design, Monitoring, and Management
Paladin Medical provides ongoing support for study management. Once a study begins, there is much to do. Data must be audited, study practice monitored, trials managed, test product delivered, investigator questions answered, and regulatory reports filed. Paladin Medical frees up your company's resources by handling these tasks.
For specific experience details and project profiles, please see the Paladin Medical Profiles in Success (pdf).
Paladin Medical Key Services
• Design of clinical trials with clear objectives and outcomes supporting regulatory submissions.
• Clinical trial report development.
• 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.
©2009 Paladin Medical, Inc.
Clinical Trial Management
Paladin Medical, Inc. 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 helps clients with all trial planning and management, such as budgets and investigator agreements for the conduct of the trial. We develop the IDE application, manage the submission and support you as sponsor to meet IDE regulations.
