EMB Services
EMB fosters a collaborative partnership with our clients, working closely to understand your unique requirements and goals. Our experts are specialists in their respective areas, and our clients appreciate that.
Data Management
▸ Certified Clinical Data Managers (CCDM)
▸ 29+ years average experience
▸ Electronic data capture support
Our Services
- Protocol to CRF design
- Database design
- CDISC compliance (CDASH/SDTM)
- Data management plan (DMP)
- Data edit checks
- Dictionary coding using standardized dictionaries (MedDRA, WHO-drug)
- External data import/transfers
- Data reconciliation
- Custom reports
- Data visualization and analytics
SAS Programming
▸ Statistics or math majors (Ph.D., M.S., B.S.)
▸ 24+ years average experience
▸ Beginning-to-end perspective
Our Services
- SDTM specifications/programming
- ADaM specifications/programming
- Define.xml and reviewers guides
- CDISC validation and compliance
- Safety lab conversion/standardization
- TLF generation (appendix or in-text)
- ISS/ISE data integration (US/global)
- Data surveillance
- Adjudication support
- Patient profiles
Stat Analysis
▸ Doctorate- and master’s-level staff
▸ 22+ years average experience
▸ Insightful and astute leadership
Our Services
- Early study planning
- Power/Sample size estimation
- Randomization (static or adaptive)
- Statistical Analysis Plan + mock TLFs
- Analysis (interim, final, meta, exploratory)
- PK/PD analysis and reporting
- Statistical writing (protocol, CSR, publications)
- ISS/ISE support for global submissions
- DMC/DSMB support (blinded or unblinded)
- IRT validation
- US/EU/Canada/Japan submission defense
EMB Statistical Solutions, LLC
|
55 Corporate Woods, 9300 West 110th Street, Suite 550, Overland Park, Kansas 66210
|
913.322.6555