IDE Study
CHALLENGE:
A medical device startup required expertise in designing, managing, and executing an investigational device exemption (IDE) study for their tissue-ablation device. The IDE clinical trial was conducted to add a new indication for the device (treating walled off pancreatic necrosis by performing direct endoscopic necrosectomy). The device had been previously approved in the United States via a 510(k), with AlvaMed supporting studies on those indications. The sponsor required AlvaMed’s experience in study document creation and in creating an electronic data capture (EDC) system to collect site and subject data for the trial. The client did not have existing staff who could support a clinical trial and needed resources to design, fully manage and execute the entire IDE study. AlvaMed was asked to provide the necessary resources due to their in-depth knowledge and experience managing and executing clinical studies.
APPROACH:
AlvaMed provided in-house clinical affairs resources to plan, design, execute and manage the study. AlvaMed created and maintained all study related documents, including the IDE Study Protocol (CIP), Investigator’s Brochure (IB), Informed Consent (ICF), and Case Report Forms (CRFs). AlvaMed also designed Clinical Procedures for the client to adhere to when conducting trials, the study EDC, and other applicable files. A clinical trial master file was created and maintained, along with study logs and tracking documents, and study monitors/clinical research associates (CRAs) were selected. AlvaMed managed the client-selected study monitors through the site initiation process, interim monitoring, and study close-out. AlvaMed also oversaw correspondence between sponsor/site/ethics committees, data management, device accountability, and site closure. Reports and study updates were generated and provided to the client in a timely manner.
RESULTS:
AlvaMed effectively conducted the IDE study, performed study data cleaning, closure, issued the final study report after meeting the client’s enrollment needs, and received De Novo clearance for the client’s device based on final IDE study report data.
During the project AlvaMed created, performed, and/or maintained:
- Clinical standard operating procedures (SOPs)
- Study documents, including the CIP, IB, ICF, and CRFs
- The Clinical Trial Master File and associated tracking logs
- Study logs for site regulatory binders
- Clinical database (EDC) and database query and reporting support
- Clinical monitoring oversight, including site initiation, interim monitoring and site closure
- Communication with applicable regulatory bodies
- Data cleaning and final study database management
- Management of data safety monitoring board, review of serious adverse events and reporting
- Clinical project management
- Final study report creation
- Client received De Novo clearance based on final IDE study report data
