{"id":9223,"date":"2026-02-24T15:30:08","date_gmt":"2026-02-24T14:30:08","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=news-events-news&p=9223"},"modified":"2026-02-24T15:36:51","modified_gmt":"2026-02-24T14:36:51","slug":"insights-from-the-ema-gcp-inspectors-working-group-annual-report","status":"publish","type":"news-events-news","link":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/insights-from-the-ema-gcp-inspectors-working-group-annual-report\/","title":{"rendered":"Insights from the EMA GCP Inspectors\u2019 Working Group Annual Report"},"content":{"rendered":"\t\t
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\n\t\t\t\t\t\t\t\t\t28\/Jul\/25\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Insights from the EMA GCP Inspectors\u2019 Working Group Annual Report<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Have you seen the EMA GCP Inspectors\u2019 Working Group Annual Report ? \ud83d\udc53
Here are a few highlights that caught our eye:<\/span><\/span><\/p>

1. Asia had a busy year \u2013 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 \u2708\ufe0f \u2026 this would be the year to cash them in.)<\/p>

2. Clinical investigator sites \ud83c\udfe5 remain the \u201cinspection favourite\u201d 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.<\/p>

3. The top categories for findings?
\u2022 General documentation issues (137 findings) \u2013 TMF, essential docs, source docs\u2026 the usual classics.
\u2022 Trial Management (86) \u2013 monitoring, data management & CSR hiccups.
\u2022 Investigational Site issues (37) \u2013 protocol deviations never go out of style.
(Source: see the tables and charts around pages 8\u201311.)<\/p>

4. \ud83e\udd21 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.)<\/p>

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

Not because it\u2019s light reading \u2013 but because it shows where the real-world challenges still are: documentation discipline, data governance, site oversight, and keeping processes aligned with evolving expectations.<\/p>

And if you ever needed reassurance: You are not the only one wrestling with document versioning, monitoring timelines or source data inconsistencies. \ud83e\udd89
\ud83d\udc49 Contact us if we should work on this together!<\/strong><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

If you think your study has a lot going on, wait until you see what 2024 looked like on the inspection side!\u2026<\/p>\n","protected":false},"template":"","class_list":["post-9223","news-events-news","type-news-events-news","status-publish","hentry"],"yoast_head":"\nInsights from the EMA GCP Inspectors\u2019 Working Group Annual Report - FGK Group<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/insights-from-the-ema-gcp-inspectors-working-group-annual-report\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Insights from the EMA GCP Inspectors\u2019 Working Group Annual Report - FGK Group\" \/>\n<meta property=\"og:description\" content=\"If you think your study has a lot going on, wait until you see what 2024 looked like on the inspection side!\u2026\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/insights-from-the-ema-gcp-inspectors-working-group-annual-report\/\" \/>\n<meta property=\"og:site_name\" content=\"FGK Group\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-24T14:36:51+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/insights-from-the-ema-gcp-inspectors-working-group-annual-report\\\/\",\"url\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/insights-from-the-ema-gcp-inspectors-working-group-annual-report\\\/\",\"name\":\"Insights from the EMA GCP Inspectors\u2019 Working Group Annual Report - 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