Data Management and Biostatistics

Delivering high quality results in a timely manner is our trademark. With our well-established and efficient processes for both paper-based and EDC trials, we guide sponsors in selecting the appropriate technology for each trial. In addition, we work hand-in-hand with sponsors to develop statistical analysis plan to meet their needs.

Our data management team is comprised of Certified Clinical Data Managers (CCDMs), and excels at the following competencies:

 

CRF/eCRF Design & Development	Query Management
Database Design & Validation	Medical Coding
Edit Check Programming	3rd Party Data Integration & Vendor Management
Double Data Entry	SAE Reconciliation
Data Review & Validation	CDISC/SDTM Programming

 

Download Data Sheet- Data Management

Our biostatistics team brings extensive experience with adaptive design, and excels at the following competencies:

 

Study Design, Sample Size, Randomization	DSMB support, DSMB membership
Statistical Analysis Plan, Mock Tables	Agency Interaction
Statistical Analysis - Disposition, Safety, Efficacy - PK/PD, ISS and ISE, Meta-analysis	SAS Programming & Validation - CDISC Mapping - Data Integration/Data Mining - Support for Abstract Publication

 

With an average 12+years of experience in our data management and statistics teams, We only have an A-team.