Insights from the EMA GCP Inspectors’ Working Group Annual Report

Have you seen the EMA GCP Inspectors’ Working Group Annual Report ? 👓
Here are a few highlights that caught our eye:

1. Asia had a busy year – 32.8% of all EMA-coordinated inspections happened there. Europe and North America followed, but Asia definitely stole the show. (If inspections had frequent flyer miles ✈️ … this would be the year to cash them in.)

2. Clinical investigator sites 🏥 remain the “inspection favourite” with 62.7% of all visits. Sponsors came in second (26.9%) and CROs contributed a modest 7.5%. Apparently, investigators are still keeping inspectors the most entertained.

3. The top categories for findings?
• General documentation issues (137 findings) – TMF, essential docs, source docs… the usual classics.
• Trial Management (86) – monitoring, data management & CSR hiccups.
• Investigational Site issues (37) – protocol deviations never go out of style.
(Source: see the tables and charts around pages 8–11.)

4. 🤡 Fun fact: Sponsors accounted for 52.8% of all findings
Investigators: 21.2%
CROs: only 1.5%
(Yes, you read that right. 1.5%. CROs everywhere are quietly framing that statistic.)

If you work in clinical research, this report is worth a look. (link to get the full report)

Not because it’s light reading – but because it shows where the real-world challenges still are: documentation discipline, data governance, site oversight, and keeping processes aligned with evolving expectations.

And if you ever needed reassurance: You are not the only one wrestling with document versioning, monitoring timelines or source data inconsistencies. 🦉
👉 Contact us if we should work on this together!