LIFE SCIENCES CAPABILITIES

STANDARDS IMPLEMENTATION

SDTM
ADaM
SEND
eCTD Compliance
Define Documentation
Up-conversion

STANDARDS DEVELOPMENT

Therapeutic Area Specific Standards
Compound Specific Standards
Client/Sponsor Specific Standards
Macro Development

STATISTICAL PROGRAMMING

SDTM Programming
ADaM Programming
SEND Programming
Define.xml generation
Reviewer's Guides
BIMO Datasets/Listings
Annotated CRF
PD Analysis

MEDICAL WRITING

Protocol Review

Study Design Consultation

PK/PD Reports

Adhoc analysis

BIOSTATISTICS

Clinical Program Development
Sample size calculation
Statistical Sections of the Protocol
Randomization schema
Statistical Analysis Plan
PK and PK/PD analysis
Interim analysis and DMC
Manuscript development

OTHER CAPABILITIES

Bio-Equivalence Analysis

Pre-Clinical Support

Integrated Summaries of Efficacy/Safety

Health Economics Outcome Research