CLASS III FIH TRIAL
CHALLENGE:
A Class III medical device startup required clinical affairs and submission support for a First in Human (FIH) study to evaluate a novel neurology implant. The company made the strategic decision to do initial clinical evaluations outside the US to prove out the device design and use the data to support filing a future US Investigational Device Exemption (IDE). The startup had strong clinical advisor support to define the study population and intended use, but needed operational expertise to lead the effort in defining a regulatory friendly location for the study, in-country study approval process, CRF and database logistics and study execution. The challenge was to meet an aggressive timeline to open study enrollment in conjunction with product availability.
APPROACH:
AlvaMed was able to work with the client and clinical advisors to define and qualify a study site with a well-known investigator in South America who had a proven track record of successful study execution in the required neurology disease state. After drafting the investigational plan, informed consent and investigator’s brochure, we used existing relationships to identify and manage in-country resources to complete the three-tiered study approval process, including successful approval from the country’s regulatory body. In parallel, AlvaMed led the process to identify and select an electronic database supplier and partnered with internal resources to successfully create and validate the database before opening enrollment. Post approval responsibilities included initial set up and maintenance of the trial master file and creation of the safety and monitoring plans.
RESULTS:
AlvaMed was able to support the company’s aggressive timelines to gain study approval and operationally prepare the company to open enrollment in advance of product availability.
During the project AlvaMed provided the following clinical support:
- Clinical standard operating procedures (SOPs)
- Study documents, including the Clinical Investigational Plan, Investigator’s Brochure, Informed Consent Documents, and CRFs
- Clinical Trial Master File and associated tracking logs
- Study logs for site regulatory binders
- Communication with applicable regulatory bodies
- Creation of the study database
- FDA export certificate approval per 802(e)(2) for an unapproved Class III device
