- Adaptive Design
- Bayesian and Frequentist Analysis
- Phase I to Phase IV Trials
- Device Trials
- Sample Size Calculations
- Randomizations
- Statistical Analysis Plan
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- Custom Reporting
- STDM and ADaM Datasets
- CDISC Conversions
- CRF Design/Review
- AE Coding
- Paper-based DM
- EDC Study Management
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- Direct FDA interaction and presenting at panel meetings
- Experience in multiple therapeutic areas
- Device Submission Support; PMA,NDA and 510k
- Bayesian and Frequentist methods resulting in regulatory approvals
- Adaptive trial design proficiency and experience
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| 02/19/2013 | - | Southeastern Medical Device Association, Annual Conference 2013, February 19th - 20th, Atlanta, GA |
| 2/28/2013 | - | Opal Events, 4th Annual Medical Devices Summit, February 28 - March 1, Boston, MA |
| 04/22/2013 | - | 2013 BIO International Convention, April 22nd - 25th, Chicago, IL |
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