In the realm of pharmacovigilance, the efficient processing of adverse event data is essential for ensuring patient safety. Marketing Authorization Holders (MAHs) often encounter challenges when dealing with Canada Vigilance cases, which are provided in PDF and Excel formats. Manual efforts, duplicate checks, validation checks, and data entry pose significant obstacles to productivity and data quality.
However, with the support of Sarjen Systems Pvt. Ltd., Lambda Therapeutic Research has implemented PvD’code, a smart Triage solution that automates the process of segregating and reconciling applicable cases from other non-relevant cases. PvD’code is a web-based software package which is now also integrated for Canada Vigilance processes.
PvD’code – Structured Intake tool
PvD’code offers a user-friendly interface compatible with popular web browsers such as Internet Explorer, Mozilla Firefox, Google Chrome, and Safari. Its key feature is the seamless handling of multiple Xmls/.xlsx files received from regulatory authorities daily. Users can easily filter and extract the required data from these files, tailored to their specific needs. PvD’code enables direct case imports, eliminating the need for labor-intensive manual data entry and significantly boosting user productivity.
Challenges with Canada Vigilance (CV) cases
- Health Canada uploads the cases in a bulk, once in month on their portal.
- CV cases come in excel and PDF formats.
- Duplicate check for CV cases is a time-consuming activity.
- CV source documents comes with a lot of information and triaging, and data entry becomes time consuming activity.
PvD’code USPs
- Automates the process of triaging case activities by downloading the cases from the CV portal in bulk and helping them to segregate.
- Auto reads Excel sheet and converts Excel sheet in an XML format.
- Assess the XMLs and identify whether the cases are valid or invalid with the help of a Predefined algorithm.
- The given algorithm can be modified as per the client’s SOP.
- Provides auto-duplicate check with the information available in the XML and helps users to decide whether the case is initial, follow-up, or duplicate.
- Sends out valid ICSR for further processing in the case processing module (auto-import facility)
- Can be used with any PV system or E2B converter and leverages an intuitive user interface to significantly reduce the manual effort required to separate the cases relevant to the MAH.
Key Benefits include:
- Offers full interoperability with any PV system or E2B converter of choice.
- Tracking of non-MAH, invalid, and duplicate cases for future analysis and review
- Speeds case reconciliation
- Maximizes efficiencies of a PV team to focus on more critical tasks.
- Deploys quickly as a cloud-based plug-in as well as on-premises.
| Without PvD’code | With PvD’code |
|---|---|
| Difficulty in bulk downloading Canada vigilance cases in PDF and Excel formats by MAHs. | Bulk downloading from Canada Vigilance Portal. |
| Substantial manual effort required for duplicate and validation checks, as well as case processing. | Robust duplicate checks with built-in validation checks. |
| Risk of quality issues arising from manual work. | Better quality and compliance, minimizing the risk of errors and ensuring adherence to regulatory standards. |
| The Lack of XML imports led to manual data entry and low productivity. | Enhancement of productivity at the book-in level by up to 40%, allowing resources to be allocated to more critical tasks.Maximum data fetching (up to 70%), minimizing manual efforts required for data entry and improving overall efficiency and accuracy. |
PvD’code Structured Intake Flow
PvD’code Hyperautomations
These are one of the industry’s most efficient and accurate end-to-end hyper-automation tools in the area of Structured E2B case intake and EV/Health Canada/MHRA cases triaging.
DROID E2B Hyper-Automation
- DROID-EMA ICSR downloader
- DROID-MHRA UK ICSR downloader
- DROID-Health Canada ICSR downloader
- DROID-MHRA UK Master XML Splitter
- DROID-Health Canada Excel to R2-XML converter
PvD’code E2B Triage Hyper-Automation
- R2 & R3 XML configuration & handling
- Automated MAH/Non-MAH check
- Automated Duplicate check
- XML PDF visualizer
- Automated follow-up check
- Automated ICSR seriousness & Validity assessment
By streamlining processes, enhancing efficiency, and improving data quality, PvD’code empowers to optimize their management of Canada Vigilance data. With its robust features and benefits, PvD’code is a valuable tool that enables MAHs to increase productivity, ensure compliance, and ultimately contribute to patient safety in the pharmaceutical industry’s Canada Vigilance landscape.
Lambda Therapeutic Research provides comprehensive drug safety & pharmacovigilance services, encompassing all clinical and post-marketing phases. Our well-established PV framework ensures thorough safety monitoring and regulatory compliance for both clinical and commercial products, offering end-to-end support across the entire life cycle of medicinal products.
