Here are the clinical data management steps we offer, spanning from clinical study initiation to study closure, presented as bullet points:

Study Start:

• Protocol Review: Understand the study protocol to determine data collection requirements.
• CRF Design: Create Case Report Forms (CRFs) for data collection, adhering to protocol specifications.
• Database Setup: Establish a database for data storage and management.

Data Collection Phase:

• Site Training: Train investigational sites on data collection procedures and guidelines.
• Data Entry: Collect and enter data from CRFs into the database.
• Quality Control: Perform data validation to ensure accuracy and completeness.

Data Management:

• Data Cleaning: Identify and rectify discrepancies, inconsistencies, and errors.
• Query Management: Communicate with sites to resolve data queries.
• Data Validation: Validate data against predetermined criteria and edit checks.
• Data Reconciliation: Compare data with other sources (e.g., safety databases).
• Coding: Assign codes to medical terms using standard coding dictionaries (e.g., MedDRA, WHO Drug).

Interim Analysis and Monitoring:

• Data Review: Review interim data to ensure quality and identify trends.
• Safety Monitoring: Monitor adverse events and ensure patient safety.
• Database Lock Planning: Prepare for database lock by ensuring all data is complete and accurate.

Database Lock and Analysis:

• Database Lock: Freeze the database to prevent further data changes.
• Statistical Analysis: Generate analysis datasets for statistical analysis.
• Statistical Review: Review analysis datasets and results for accuracy.

Study Closure:

• Database Lock Review: Verify that the database is locked and final.
• Data Export: Extract data for further analysis or reporting.
• Clinical Study Report (CSR): Collaborate with medical writers to prepare the CSR.
• Archiving: Archive study documentation, data, and records according to regulatory requirements.

Study Archiving and Audit Trail:

• Audit Preparation: Prepare for potential audits by ensuring data integrity and documentation.
• Archiving and Retention: Store study documentation and data per regulatory guidelines.
• Data Access: Maintain data access for potential future reference or regulatory inquiries.

Our comprehensive clinical data management services encompass these pivotal steps, ensuring that your study data is collected, managed, and analyzed with meticulous precision from study initiation to closure.