Maximizing Value for Scientific and Medical Affairs
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Princeton, NJ 08540 USA


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 is a powerful collaboration portal designed for pharma companies to manage the complete lifecycle of different Investigator Initiated Trials programs. With the easy to use configurations, the portal can setup very quickly to effectively engage with potential investigators and conduct trials in a regulatory compliant manner.
Medical Science


Easy to Configure

Facilitates Stakeholder Collaboration

Increases Quality and Compliance
• Setup Programs specific to Products and allocated Funds
• 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
• Investigators and Organizations (NGOs, Universities, Research Institutions, Hospitals) can register on the pharma company’s IIT portal
• Verify authenticity of registered users based on various datapoints (NPI, Practitioner Medical License Number, etc.)
• Sponsors can easily qualify Investigators based on the submitted credentials and selectively grant access permissions to individual programs
• Study Protocol Review and Approval submitted by Investigator
• Track submissions and approvals from regulatory body and Regional Ethics Committee
• Evaluate IIT requests to approve, reject and request for information with pre-defined business rules and acceptance criteria
• 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
• Manage product and fund requests with approval, allocation, logistics, etc.
• Perform expenditure tracking and trial related reimbursements
• Perform return and retrieval of investigational product
• Schedule and Mange investigation site evaluations for multiple centers during initiation, conduct and close out of the study
• 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

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