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 - Project Management

Peachtree will provide project management oversight to ensure quality and adherence to agreed timelines.  Peachtree will create a Data Management Plan that describes the specific data management activities and procedures that will be followed to meet the requirements of the Clinical Trial Protocol in compliance with sponsor procedures, international or national regulations and Good Clinical Practices. 

Peachtree will participate in study team meetings as outlined in the Data Management Plan.  Peachtree will supervise the activities of external data vendors and CRF printing vendors to ensure the completion of all deliverables.  Specific data listings, CDM status updates, and metrics will be provided on regular basis as agreed upon in the Data Management Plan.

Peachtree will write a DMR that includes at least:  study personnel and responsibilities, executive summary, deviations from the DMP, specific problems and solutions, unresolved queries (if any), outcome of quality control execution and conclusions on data quality.  Peachtree will lock the final database by suppressing all write accesses.  Peachtree will extract the final SAS datasets and provide to the sponsor at the conclusion of the study.