current landscape & ICSR challenges
ICSR case processing process within Pharmacovigilance operations is becoming complex owing to multiple unstructured data sources. There are more data sources than ever including social media, real-world data, electronic patient health records, insurance claims, etc.
Converting this unstructured information to structured format to feed into the global safety database using manual processes is error-prone and more resource-intensive.
High operational cost to manage the unstructured data due to lack of technology that integrates with existing safety systems.
High volume of data from disruptive technology like smart sensors and wearables are increasing the main source of patient data for virtual or decentralized trails and patient-centric trails.
our ICSR automation solution
Automating the intake of the adverse events for ICSR reporting from various unstructured data sources to structured data formats like E2B can be technologically viable.
All the unstructured data elements can be mapped/extracted to a structured format using advanced technologies like AI and machine learning translation, ontology searches, extraction of text embedded in the image and scanned PDF documents, medical transcriptions, speech to text conversion, relationship extraction for medication, etc. All these data processing services allow users to easily classify incoming adverse events into high-level categories and drastically reduce the time spent by human teams.
Technologies like Robotic Process Automation (RPA), NLP, NLG and cloud computing, along with the above-mentioned data processing services, using vendors like AWS, Microsoft, Google, etc. will be crucial for Regulatory and safety operations.
Importing the final structured E2B output of the adverse events in the safety system, along with an expert, to finalize and validate the adverse events will reduce the overall cost and increase efficiency.
ICSR – automation benefits
- Enhanced patient wellbeing by strengthening safety signal detection and benefit risk.
- PV Operational cost and time reduction.
- Increased efficiency and quality there by improving the data integrity.
- Reduces repetitive manual task and deployment of the human resources to value added higher level of process.
- Scalability to handle high volumes in a real time with increased compliance to regulatory timelines.
- Ease of integration with all Safety systems.