Data Services

• Statistical Analysis Plans
• Calculate sample size
• Generate randomization codes
• Perform statistical analyses using Statistical Analysis System (SAS®)
• Prepare electronic files, with documentation, in SAS®

Study Start-up

eCRF Design

User Acceptance Testing

Data Validation Plan

• Online (Real Time, Batch): Integrated with EDC
• Offline (SAS)

EDC User Training

Data Management Plan

External Data Integration

• Data Transfer Specification
• Central Lab
• ECG Core Lab
• Pharmacokinetic/Pharmacodynamic Data
• IxRS Data
• CTMS Data
• ePRO
• Devices

Study Conduct

Data Review/Cleaning

• Data Tables, Listings and Figures

Patient Profile

DSMB Support

External Data Reconciliation

SAE Reconciliations

Medical Coding

• MedDRA
• WHO Drug

Data Standard

• CDISC SDTM Mapping Annotation (aCRF)
• CDISC SDTM Mapping Programming
• CDISC SDTM Define.xml
• CDISC SDTM Reviewer’s Guide
• Sponsor Specific Standards

Study Closeout

Database Lock

• Multiple DB Lock Support
• - Adaptive Study Designs
• - Interim Analyses
• - Final Lock
• Clean File Meeting
• - Data Lock Documentation

Regulatory Submission Support

SAS

Target Health Clinical Trials Software Suite

• Target e*CRF® (EDC)
• Target e*CTR® (eSource/Direct Data Entry)
• Target e*ICF® (Electronic Informed Consent)
• Target IWRS (Randomization)
• Target e*IMP (IMP Management)
• Target ePRO (Electronic Patient Reported Outcome)
• Target e*Monitoring® (Monitoring Reports)
• Target e*Pharmacovigilance® (SAE Reporting)
• Target Encoder® (Medical Coding)
• Target Document® (Document Management)

Pinnacle 21 (SDTM Validation)