Case Processing

Streamlining Your Clinical Trial Data with Precision

Efficient case processing is crucial for the accuracy and success of your clinical trials. At Safevigilance, our Case Processing Services are designed to manage, analyze, and report clinical trial data with utmost precision and efficiency. Trust us to handle your data processing needs while you focus on advancing your research.

Our Case Processing Services

1. Case Report Form (CRF) Management

Ensure seamless collection and management of clinical data through our CRF services:
  • ● CRF Design: Development of user friendly and regulatory compliance case report forms.
  • ● Data Entry: Accurate and timely entry of data from completed CRFs.
  • ● CRF Tracking: Ongoing monitoring and tracking of CRF completion and data quality.

2. Data Cleaning and Validation

Maintain the integrity and accuracy of your clinical trial data with our rigorous data cleaning services:
  • ● Data Review: Comprehensive review to identify and resolve inconsistencies or errors.
  • ● Validation Checks: Application of validation rules to ensure data quality and completeness.
  • ● Correction and Query Management: Efficient handling of data queries and corrections.

3. Adverse Event (AE) Processing

Manage and report adverse events effectively to ensure participant safety and regulatory compliance:
  • ● AE Data Collection: Accurate collection of adverse event information from trial participants.
  • ● AE Evaluation: Detailed assessment and classification of adverse events.
  • ● Regulatory Reporting: Preparation and submission of adverse event reports to regulatory authorities.

4. Serious Adverse Event (SAE) Management

Handle serious adverse events with a focus on timely reporting and compliance:
  • ● SAE Tracking: Realtime tracking and documentation of serious adverse events.
  • ● Urgent Reporting: Immediate reporting to regulatory bodies as required.
  • ● FollowUp: Ongoing monitoring and followup to ensure resolution and accurate documentation.

5. Data Integration and Reconciliation

Ensure consistency and accuracy across all data sources with our integration services:
  • ● Data Integration: Combining data from multiple sources into a unified dataset.
  • ● Reconciliation: Cross Checking and aligning data to resolve discrepancies.
  • ● Reporting: Generation of integrated reports for analysis and decision making.

6. Regulatory Submission Support

Facilitate smooth regulatory submissions with comprehensive support services:
  • ● Submission Preparation: Compilation and preparation of case processing data for regulatory submissions.
  • ● Documentation: Ensuring all required documentation is complete and compliant.
  • ● Regulatory Interaction: Support for interactions with regulatory agencies during the submission process.
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