Case Data Intake from Regulatory Agencies
Pharma companies are required to download files from the EV Web portal and Canada Vigilance based on active substances (not based on the company’s products). Due to this regulatory change, Pharmacovigilance operations at small to mid-size companies are challenged with timely completion of review and submission of huge volumes of ICSRs. It is must for companies to include these ICSRs in the company’s centralized safety database to comply with other regulatory agencies for expedited reporting.
Common Regulatory Intake Challenges
- Manual filtering of company specific AE cases from Eudravigilance Web and Canada Vigilance database and completing ICSR intake
- Lengthy redundant and error-prone process to compile Individual Case Safety Reports (ICSRs) and finish case processing
- Users have to download multiple excel files from the Canada Vigilance database and apply filters to segregate their company data
- Poor visibility on case volume processed from these regulatory safety databases with disconnected communication and no historical tracking
- Lack of awareness on reporting delays and other issues that could result as findings during audits and inspections
Introducing Compier Intake - Agency
Compier Intake enables seamless AE intake, receipt, and triaging from various sources such as PDFs, emails, etc. through automated data point check and import of safety cases directly into the safety database. It also has a built-in Inbox for distribution of safety case related emails to different business partners and vendors. It also enables automated case filtering and ICSR intake from safety data obtained from the Canada Vigilance and Eudravigilance database. Our platform automatically reads the product information from the E2B R3 files (from EV Web) and CSV files (from Canada Vigilance) and auto-creates a valid safety case without any manual intervention.
Compier PV Ops Intake Automation and Agentic AI solutions are designed to transform this critical first step of the case lifecycle by leveraging intelligent automation, LLMs, and PV-trained agentic AI to reduce human workload, accelerate turnaround times, and enhance data quality.
Our agents extract relevant data points like adverse event terms, product details, reporter information, seriousness, and timelines streamlining the intake process before cases even enter Argus Safety or other drug safety systems from various structured and unstructured sources such as Emails & attachments (PDF, Word, scanned documents), Medical Information systems, Product complaint portals, Literature databases (e.g., Embase, PubMed), Call center transcripts and voice-to-text sources.
Key Benefits of Compier PV Ops Intake Automation & Agentic AI
Solution FAQs
We offer the Compier solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier Intake & Mailbox modules along with the required system integrations.
Compier Intake & Mailbox modules are part of the PVOps Management platform. All modules are GxP compliant and meet FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.
Our subject matter experts will deliver a hands-on Compier Intake application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations.
The Compier PV Aggregate solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity.
The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions.
Compier PV Ops Modules
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