Investigator-Initiated Trials are vital for taking new treatments and therapies from bench to bedside. Leveraging external researchers can bring many creative and cost-effective advantages – but it also raises new challenges.
DGE invites you to attend its 2nd Investigator-Initiated Trials Summit–no other event goes into as much depth about engaging with investigators, designing and executing the best study protocols, and streamlining product innovation and patient safety.
Join your industry colleagues for this unique learning opportunity and gather the tools and insights you need to ensure a successful, compliant IIT.
- Review of the complex regulatory requirements of sponsor-investigator research
- Surefire methods to manage and implement, successful and compliant IIT/IIS
- Insight to understanding Fair Market Value (FMV) and aligning IIS with corporate strategy
- Guidelines to Develop and Follow Standard Operating Procedures (SOP) for the Research Site
- Review the value of investigative research and the tools that are essential for your organization
- Understand how to best align research with goals of your organization
- A roadmap for developing budgets, contracts and assessing FMV
- Investigator-Initiated Sponsored Research (IISR/IIS)
- Medical Affairs
- Field Medical Affairs
- Medical Science Liaisons (MSLs)
- Field Medical Science Liaisons
- Grants Management
- Site Management
- Clinical Research
- Clinical Trial Monitoring
- Research Collaborations
- Publication Planning
- Phase IV
- Legal & Regulatory Affairs
- Clinical and Research Investigators
- Post-Market Studies
IIT/IISR service providers:
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Investigator-Initiated Sponsored Trials (IITs)
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Clinical Affairs
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CROs
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Regulatory compliance consultants
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Site selection and management
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Medical Writing Firms
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Law Firms
