Services

Clinical Project Management

Clinical Operations

Clinical Data Management

- CRF Design

- Database Development

- Edit Check Programming

- Scanning, Data Entry

- Query Management

- External Data Management

- Medical Coding

- SAE Reconciliaion

- Quality Assurance

- Project Management

- Electronic Data Capture

Biostatistics

Medical Writing

Clinical Quality Assurance

Clinical Resourcing

Functional Service Teams

Technology

Clinical Data Management - Serious Adverse Events (SAEs) Reconciliation

Peachtree will generate data listings for SAEs entered in the clinical database.  These data will be compared to data from the drug safety database.  The items typically reconciled are:
Subject identity, AE preferred term, Outcome, Causality assessment by the investigator, Onset date, and Data of Death (if applicable). 

Queries will be generated as necessary and the process will be documented.