ICSR Reporting

September 30, 2025

ICSR Reporting

📑 Tracking regulatory submissions shouldn’t require endless spreadsheets.
But for many PV teams, managing ICSR reporting across agencies means manual tracking, external task lists, and risk of missed deadlines.

With Flex Databases’ improved Pharmacovigilance Submissions Tracker, everything is now in one place:

âś” Define flexible submission rules by drug, project, and conditions
âś” Configure statuses to match your internal processes
âś” Navigate easily with structured tabs: Not Reported, In Progress, Completed
âś” Report directly from the tracker (XML batches, CIOMS forms)
âś” Benefit from automatic updates for gateway submissions

👉 More control, less manual work! Ensure timely and compliant reporting.

Blog

November 18, 2025
BIOTRONIK Selects Flex Databases as a Major System to Cover Clinical Trial Related Activities

BIOTRONIK, a leading global medical device company, has selected Flex Databases as its trusted eClinical partner to streamline and enhance the management of its clinical trial operations through Flex Databases’ unified platform. Comprehensive Functionality and Strong ROI Following a rigorous evaluation process, BIOTRONIK chose Flex Databases for its broad functionality, competitive pricing, and exceptional return […]

November 10, 2025
We Are Hiring: Project Manager

Flex Databases team is looking for a Project Manager to join our Customer Success Management team, based in our Prague office. While this role can be fully remote within Czechia, you must be available to visit the office for occasional client meetings.  Preferred location: Prague.  Fluency in German is essential for this position, as you […]

We Are Hiring: Associate Project Manager

Flex Databases is looking for an Associate Project Manager to join our Customer Success Management team, based in our Prague office. While this role can be fully remote within Czech Republic, you must be available to visit the office for occasional client meetings.  Required location: Prague   We are united by a strong mission to make […]

November 6, 2025
Speaker Announcement | Case Study of Data Migration: A Nightmare or a Real Need in 2025?

We are excited to have Marietta Sarkisian, Global Director, Business Development & Marketing at Flex Databases, take the stage with a powerful case study: “Data Migration: A Nightmare or a Real Need in 2025?” She will cover: âś… Partnering for Transformation – Why SOLTI chose Flex Databases to overcome CTMS limitationsâś… Migration Process – Structured […]

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We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.