INVESTIGATOR INITIATED STUDIES
Investigator-initiated studies (IIS) are research projects that are initiated and conducted by a single investigator, institution, university, cooperative group, or association. We offer tailored solutions for IIS right from the development of study documents to closeout and report writing while maintaining the independence of the Investigator and complying with guidelines.
Start-up Activities
- Study Document Development
- eCRF and Database Development
- Translation of Study Documents
- Ethics Committee and Regulatory Submissions
- Project Planning
Study Conduct Phase Activities
- Supporting Patient Enrolment
- Monitoring
- Safety Reporting
- Data Management
- eTMF Maintenance
Study Close-out Activities
- Statistical Analysis
- Study Report Preparation
- Manuscript Writing
- Presentation Preparation for Conferences
- Archival