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This tool empowers you to systematically reconcile and incorporate all Individual Case Safety Reports (ICSRs) received from global partners, ensuring adherence to specified timelines. This guarantees 100% compliance with Partner Safety Data Exchange Agreements (SDEA), providing you with confidence in the integrity of your safety system.
Key Features
Configurable Excel Comparison
SafetySync provides users with the flexibility to configure Excel sheets of varying structures for ICSR data.
The tool intelligently compares the configured Excel files, accommodating different data formats and structures commonly used by partners and affiliates.
Dynamic Partner Configuration
Users can easily configure different partners within SafetySync, each with its specific data format and structure requirements.
This dynamic partner configuration feature ensures adaptability to the diverse reporting formats encountered in partnerships.
Versatile Data Comparison
SafetySync's algorithmic engine performs a comprehensive comparison of ICSR data, considering various attributes such as patient information, adverse events, timelines, and other relevant parameters.
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User-Friendly Interface
The tool boasts an intuitive and user-friendly interface, allowing users to seamlessly navigate through the configuration and comparison processes.
Clear instructions and prompts guide users in configuring Excel files and interpreting comparison results.
Detailed Result Output
SafetySync generates detailed result outputs after each comparison, highlighting matching and non-matching data points.
The tool provides granular information, empowering users to identify specific areas of discrepancies for further investigation.
Scalability and Efficiency
SafetySync is designed to handle large volumes of ICSR data efficiently, ensuring scalability for pharmaceutical companies with extensive partner networks.
Workflow
Configuration Setup
Users configure Excel files representing ICSR data for both their organization and each partner or affiliate.
SafetySync allows users to define the structure and format of the Excel sheets, accommodating the specific requirements of each partner.
Users set up partner profiles within SafetySync, specifying the unique data format and structure associated with each partner.
Partner Configuration
Automated Data Comparison
SafetySync's algorithmic engine performs automated comparisons between the configured Excel sheets, identifying matching and non-matching data points.
Detailed result outputs are generated, clearly presenting the discrepancies between the ICSR data of the pharmaceutical company and that of its partners.
Users can analyze the results to determine the scope and nature of discrepancies.
Result Analysis
Resolution and Reconciliation
The results produced by SafetySync serve as valuable inputs for the reconciliation process.
Users can take informed actions to resolve discrepancies, ensuring that the ICSR data aligns with regulatory requirements and internal standards.
Benefits
Adaptability and Flexibility
SafetySync's configurability allows pharmaceutical companies to adapt to various partner data formats, ensuring compatibility with diverse reporting structures.
Time and Resource Efficiency
The automation of data comparison eliminates the need for manual Excel sheet comparisons, saving time and resources for pharmacovigilance teams.
Error Reduction and Accuracy
The algorithmic approach reduces the risk of human errors associated with manual reconciliation, improving the accuracy and reliability of the process.
Compliance Assurance
SafetySync enables pharmaceutical companies to demonstrate compliance with regulations by providing a systematic and auditable approach to ICSR reconciliation.
Streamlined Partner Management
The tool simplifies the management of multiple partners by allowing for dynamic configuration, making it easier for organizations to collaborate seamlessly.
In conclusion, SafetySync emerges as a pivotal tool in the pharmacovigilance landscape, offering a sophisticated and configurable solution for ICSR reconciliation. By automating the comparison of Excel sheets with diverse structures, SafetySync enhances efficiency, reduces manual effort, and ensures pharmaceutical companies maintain compliance with regulatory standards in their partnerships and affiliations.