Case Study: Global Reporting Rule and Audit Capture Engine (GRRACE) solution
Global Reporting Rule and Audit Capture Engine (GRRACE) solution automated the process of creating new reporting rules or modifying existing ones in Argus Safety at a top tier Pharmaceutical Company
Overview
Nextrove has been supporting one of the world’s premier biopharmaceutical companies to automate, simplify and optimize the end-to-end development of Argus Safety reporting. Nextrove’s GRRACE (Global Reporting Rule and Audit Capture Engine) application has been leverage for the project.
The Goal
Creation and maintenance of Argus Safety reporting rules to auto-schedule reports for submissions to multiple destinations includes several steps and multiple stakeholders:
Reporting rules are a critical component of Argus Safety configuration to ensure compliance with regulations. Each step requires approval by respective stakeholders and extensive QC. Additionally, the cycle re-start to incorporate in reporting rule any new regulatory change including tracking of the relevant maintenance activities to demonstrate compliance with the effective date of regulations.
The manual end-to end process includes a series of hand-offs, paper-based configuration design, archive maintenance to document the entire cycle from requirements to testing, from QCs to approvals and to deployment.
Objective of project was to automate the entire end-to-end process, to track all actions, to keep records of approvals, to support inspections readiness via an application audit-ready, and to maintain and monitor metrics.
The Approach
Nextrove GRRACE application includes a workflow with various steps, and it is audit ready.
The process starts with entry of regulatory requirements by the business department(s). Upon approval, the second step includes the automatic transposition of requirements,
based on defined and configured rules, into a screen mimicking the fields of Argus console. An Advance Condition (AC) Library is available to select the appropriate AC. Following approval of the reporting rule design, the reporting rules script designer supports the preparation of test scripts. Upon approval of test script, testing is performed, and results embedded and archived in the application. Deployment in Argus Safety and in multiple environments happens automatically and Argus Safety console is automatically populated, following approval of test results.
The Benefits
Nextrove GRRACE automates the process of creating new reporting rules or modifying existing reporting rules in Argus Safety.
Nextrove GRRACE provides one single repository for activities, approvals and documentation supporting the creation of reporting rules and increases efficiencies by eliminating manual hand-offs.
Additionally, by automating key stages from requirement to deployment, it significantly reduces operational costs and time.
From a quality perspective, Nextrove GRRACE ensures transparency for end-to-end process and facilitates inspection readiness by incorporating the audit trail and providing a dashboard to generate reports and collect metrics.
Client Testimonials
Nextrove Team showed consistency, passion and Knowledge and contributed at the highest level for the go-live accomplishment. They are all resources I would like to work with in upcoming activities
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Case Study: Progressive Global Follow-up Automation (GFA) solution
Progressive Global Follow-up Automation (GFA) solution transformed the entire follow-up process at a top tier Pharmaceutical Company
Overview
The role of pharmacovigilance is monitoring safety of marketed drugs and investigational products to support and ensure patient safety. When first received, adverse event information is often incomplete. These reports should be followed-up as necessary to obtain supplementary detailed information significant for the scientific evaluation of the cases. Client followed a manual process for generating follow-up letters and questionnaires with specific event/product pair questions.
This process is labor-intensive, with a suboptimal rate of response from reporters and includes a high cost for mailing. Lack of a user-friendly mechanism to provide responses by the reporters required additional manual intervention by the Client teams.
Increasing number of new sources of information need to be managed like social media, patient support programs or customer engagement programs.
The budget allocated to case processing is a large amount of the total pharmacovigilance budget and is growing due to increasing case volume.
Solution
Nextrove collaborated with the Client and launched a project to optimize and automate the follow-up data collection process by leveraging Progressive GFA. GFA application enables business users to streamline the process by auto-identifying missing data in a case, then generating custom configured letters and questionnaires for product/event pairs including only the specified missing data, accompanied with a cover letter.
Deployed 440 letters and questionnaires in 38 languages.
Nextrove configured Progressive GFA to generate follow-up letters and questionnaires with pre-defined data fields and to identify the supplementary data to be requested for the case according to Client policies and business process.
GFA enabled the capability to enter reporter’s responses, when provided via phone, directly in the application and to ingest the relevant form automatically as source document in the safety database.
Following Client operational procedures, action items management was automated (e.g. closure of follow-up letter action items, and management of reminders).
GFA is audit and inspection ready. All activities performed through this application, are tracked allowing follow-up monitoring and relevant metrics generation.
Results
Client Testimonial
“Thank you Nextrove team for the tremendous efforts, dedication, and hard work in implementing this innovative and complex project with finesse and great success. It stands as a testimony to the Nextrove team's extraordinary skills and expertise. Kudos to you all! “
Perspective: GFA Return on Investment
Greater than 150% ROI, ROI grows with growing case volume.
Assumptions: 1. Follow-up data collection is done via email for 80% of the 3000-case volume per year 2. Postal communication scenarios are excluded and not applicable 3. Industry averages (on the conservative side) have been used for the calculation.