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Overview
Mission Statement
To provide data analysis, data management, data reporting, and medical writing services enabling innovation for emerging life science research.
Innovative Analytics was founded in 2003 and comprises many talented senior pharmaceutical professionals with broad life science support experience:
- Phase I and pharmacokinetic/pharmacodynamic modeling support (Winnonlin), including thorough QTc studies
- Exploratory development — biomarkers, quantitative imaging, pharmacogenomics
- Phase II-III registration support
- Clinical document preparation from early to late development, as well as post-approval, including registration-related documents, manuscripts, and presentations
Regulatory/Health Authority Experience
- GLP, GCP, ICH
- Electronic submissions
- Drug Information Association (DIA) instruction on SOP development and audit preparation
- Submission development and issue resolution for and defense of US, EU, and Japanese marketing registrations and Orphan Drug Submissions
- PMA and 510(k) device applications
- End-of-phase II, issue resolution, and pre-NDA meetings with US FDA
- Data Safety Monitoring Boards
- External statistical representation
- Internal support (dataset creation and coordination)
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