EMB Services
Having the Know-How
We focus on what we do best. You won't find us trying to be everything to everybody. Our experts are specialists in their respective areas, and our clients appreciate that. Our data management system was designed by our SAS® programmers and developed internally to optimize the flow of data. It is fully validated and 21 CFR Part 11 compliant.
EMB programmers and biostatisticians are analysis experts specializing in SAS® software.
Pre-Study
Study Design
Power / Sample Size Estimation
Protocol Development
Randomization Schedule
Statistical Modeling
On-Study
Analysis Plan
Mock Report
Data Summary
Statistical Analysis
Primary Results Report / Comm.
Interim Analysis Report
Final Report Generation
Post-Study
Publications
Peer-Review
Integrated Summaries
Submission Activities
Project Support
New Drug Application
Data Safety Monitoring
Data Surveillance
Phase I-IV, Pharmacokinetics/ Pharmacodynamics and Pharmacoeconomics
EMB data managers can rapidly process data, via paper or electronic data capture.
Pre-Study
CRF Design
Data Management Plan
Data Entry Design
Database Design
On-Study
CRF & Query Tracking
Pre-Entry Review
Independent Double Data Entry
Data Encoding
Query Resolution
Database Management
Electronic Data Transfer
Data Reconciliation
Data Surveillance
Data Validation
Database Audit / Finalization
Report Generation
Post-Study
Electronic Database Delivery
Database Archiving
Data Mgmt. Documentation
Submission Activities
Project Support
Database Integration
Database Standardization
Software Tool Development
Data Conversions
Quality Control
CDISC Assistance
Services available are not limited to those listed on this page. To inquire about a specific service or capability, please contact us.
CDISC Compliance
DSMB Support
EDC Systems
CDISC
As a member of the Clinical Data Interchange Standards Consortium, EMB can support your transition to CDISC data standards. Our statistical programmers assist with the implementation of CDISC standards with extensive experience in programming both SDTM and ADaM data sets created to be submission-compliant. In addition, we can develop data-conversion plans and case report tabulation data definition specification – "DDT" or "define" document (.xml, .pdf, etc.).
DSMB
Our statisticians have a wealth of experience with Data and Safety Monitoring Boards including charter development, meeting organization, and generation of safety and efficacy analyses. EMB can tailor the level of support based on your needs and program TLFs for the DSMB, or run and verify programs developed by the client.
EDC
With a wealth of experience working with electronic data capture systems, EMB data managers help you by providing oversight and solutions for data issues that may arise when using EDC for a study. We are able to identify potential data problems and quickly resolve issues that may not have been anticipated.
EMB Statistical Solutions, LLC | 55 Corporate Woods, 9300 West 110th Street, Suite 550, Overland Park, Kansas 66210 | 913.322.6555 | info@embstats.com