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


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.


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.



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.

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