Digitalize Investigator Initiated Trials Management to support Scientific Evidence Generation
While many clinical trials are initiated by industry sponsors, other trials originate within a research site by an investigator. In recent years there is an increase in Investigator Initiated Trial Programs in industry on marketed drugs or drugs with an existing IND to answer clinical questions that have an important impact on public health and patient needs including identification of new indication. With the increase in number of programs, there are updated guidelines released by FDA and other agencies for conduct of IITs.
The benefits of IITs are often offset by the multiple challenges and obstacles a sponsor or a CRO faces from initiation, conduct and closure. These include regulatory submission tracking, informed decision making, data management, continuous oversight, program tracking, regulatory compliance and adhering to standard operating procedures.
SCIMAX IIT
Easy to Configure
Facilitates Stakeholder Collaboration
Increases Quality and Compliance
• Define pre-requisites for registration and submission of requests
• Define workflows and configure forms required for different stages of a program with options to collect documentations related to approvals and amendments
• Verify authenticity of registered users based on various datapoints (NPI, Practitioner Medical License Number, etc.)
• Study Protocol Review and Approval submitted by Investigator
• Track submissions and approvals from regulatory body and Regional Ethics Committee
• Define Work Instructions and Help Content to support requestors for submitting IIT applications and for sponsor’s internal users to evaluate such requests
• Manage all email communication between external user and sponsor directly from the SCIMAX IIT application
• Perform expenditure tracking and trial related reimbursements
• Perform return and retrieval of investigational product
• Track subject informed consent, accrual rate, study events, trial progress and outcomes (Adverse Events, Dropouts, etc.)
• Mange the whole project while providing transparency across internal and external stakeholders through to publication and completion
