Our services include:
- Adaptive Design
- Bayesian and Frequentist Analysis
- Phase I to Phase IV Trials
- Device Trials
- Sample Size Calculations
- Randomizations
- Statistical Analysis Plan
- Publication Support
- ISS/ISE Packages
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- STDM and ADaM Datasets
- CDISC Conversions
- CRF Design/Review
- AE Coding
- Double Data Entry
- Paper-based Studies
- EDC Vendor Management
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- Direct FDA interaction and presenting at panel meetings
- 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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| 03/13/2012 | - | Southeastern Medical Device Association, Annual Conference 2012, March 13th-14th, Atlanta, GA |
| 02/15/2012 | - | CED Life Science Conference 2012, Feb 15th-16th, Raleigh, NC |
| 01/09/2012 | - | OneMedForum San Francisco 2012, Jan 9th -12th |
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