# FGK Group

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## Pages
- [Start](https://fgk-group.com/)
- [Impressum](https://fgk-group.com/imprint/)
- [Imprint](https://fgk-group.com/imprint/)
- [Kontakt FGK PV](https://fgk-group.com/fgk-pv/fgk-pv-contact/)
- [Kontakt FGK CRO](https://fgk-group.com/fgk-cro/fgk-cro-contact/)

## News \& Events \- News
- [New Partnership with OmniComm Systems](https://fgk-group.com/news-events/news/new-partnership-with-omnicomm-systems/): FGK Clinical Research Signs Five\-Year Agreement with OmniComm Systems for Multiple eClinical Products
- [New Partnership with OmniComm Systems](https://fgk-group.com/news-events/news/new-partnership-with-omnicomm-systems/): FGK Clinical Research Signs Five\-Year Agreement with OmniComm Systems for Multiple eClinical Products
- [Einladung zum 27\. BVMA Symposium in München](https://fgk-group.com/news-events/news/einladung-zum-27-bvma-symposium-in-munchen/): Am 29\. November findet unser 27\. BVMA Symposium statt – im altbewährten Sheraton Arabellapark Hotel\.

Diesmal zum Thema: Digitalisierung der…
- [Einladung zum 27\. BVMA Symposium in München](https://fgk-group.com/news-events/news/einladung-zum-27-bvma-symposium-in-munchen/): Am 29\. November findet unser 27\. BVMA Symposium statt – im altbewährten Sheraton Arabellapark Hotel\.

Diesmal zum Thema: Digitalisierung der…
- [Scale Up Europe Fund](https://fgk-group.com/news-events/news/scale-up-europe-fund/): A €5bn Scaleup Europe Fund has been launched to support strategic technology businesses which may benefit European biotech companies\.

## News \& Events \- Events
- [Biotech Showcase](https://fgk-group.com/news-events/events/biotech-showcase-1/): FGK participates with Ursula Türcke and Martin Krauss at Biotech Showcase in San Francisco, USA\.
- [Biotech Showcase](https://fgk-group.com/news-events/events/biotech-showcase-1/): FGK participates with Ursula Türcke and Martin Krauss at Biotech Showcase in San Francisco, USA\.
- [BioFIT](https://fgk-group.com/news-events/events/biofit-1/): FGK participates with Barbara Weckerlein and Jennifer de la Peña at BioFIT, Marseille, France\.
- [BioFIT](https://fgk-group.com/news-events/events/biofit-1/): FGK participates with Barbara Weckerlein and Jennifer de la Peña at BioFIT, Strasbourg, France\.
- [KoNect 2026](https://fgk-group.com/news-events/events/konect-2026/): FGK participates with Jennifer de la Peña at KoNECT 2026 in Seoul, South Korea\.

## Knowledge Hub \- Magazine
- [Wie Deutschland die klinische Forschung fördert: Teil 3 \- Spezialisierte Ethikkommission für besondere Verfahren \(SEKbV\)](https://fgk-group.com/knowledge-hub/magazine/how-germany-is-boosting-clinical-research-specialized-ethics-commitee/): Um das Einreichungsverfahren für klinische Studien zu vereinfachen, wurde durch das Gesetz über die medizinische Forschung in Deutschland eine Spezialisierte Ethik\-Kommission für besondere Verfahren \(SEKbV\) eingerichtet\.
- [Zeitpläne für klinische Studien: Warum Studien in frühen Phasen Verzögerungen erfahren und wie sich die Vorhersagbarkeit verbessern lässt](https://fgk-group.com/knowledge-hub/magazine/clinical-trial-timelines/)
- [Clinical Trial Timelines: Why Early\-Phase Studies Slip and How To Improve Predictability](https://fgk-group.com/knowledge-hub/magazine/clinical-trial-timelines/): Find out why clinical trial timelines are systematically overestimated and learn how sponsors can improve predictability in early\-phase development\.
- [AI in clinical trials: Benefits, Applications \& Future](https://fgk-group.com/knowledge-hub/magazine/ai-in-clinical-trials-benefits-applications-future/): AI in clinical trials brings automated, data\-driven methodologies to processes that once relied on manual effort, touching every stage of clinical development\. We provide a comprehensive summary about the current spectrum of AI Applications in Clinical Research\.
- [Resilience in a Biotech Downturn](https://fgk-group.com/knowledge-hub/magazine/resilience-in-a-biotech-downturn/): How the 2022–2025 Biotech Downturn reshaped clinical research\. Discover why team continuity and ownership structure are now the primary metrics for CRO selection\. 

## Knowledge Hub \- Glossary
- [CDISC](https://fgk-group.com/knowledge-hub/glossary/cdisc/): Eine globale, gemeinnützige Organisation, die einheitliche Datenstandards für die klinische Forschung entwickelt, um die Qualität, Konsistenz und Interoperabilität klinischer Daten zu verbessern\.
- [CDISC](https://fgk-group.com/knowledge-hub/glossary/cdisc/): A global, non\-profit organization that develops data standards to streamline clinical research and improve the quality, consistency, and interoperability of clinical data\.
- [Auftragsforschungsinstitut \(CRO\)](https://fgk-group.com/knowledge-hub/glossary/contract-research-organization-cro/): Ein Unternehmen, das ausgelagerte klinische Forschungsdienstleistungen anbietet und klinische Studien im Auftrag von Sponsoren durchführt\.
- [Sponsor](https://fgk-group.com/knowledge-hub/glossary/sponsor/): Eine Person oder Organisation, die für die Initiierung, Verwaltung und Finanzierung einer klinischen Studie verantwortlich ist\.
- [ISO 14155:2020](https://fgk-group.com/knowledge-hub/glossary/iso-14155-2020/): Internationale Richtlinien für die Durchführung klinischer Prüfungen von Medizinprodukten am Menschen, die die ethische und wissenschaftliche Integrität sicherstellen\.

## Career
- [Unsolicited application](https://fgk-group.com/career/unsolicited-application-initiativbewerbung/)
- [Initiativbewerbung](https://fgk-group.com/career/unsolicited-application-initiativbewerbung/)
- [Why us](https://fgk-group.com/career/why-us/)
- [Warum wir](https://fgk-group.com/career/why-us/)
- [Wer wir sind](https://fgk-group.com/career/who-we-are/)

## About Us \- FGK RS
- [FGK Representative Service Ltd](https://fgk-group.com/fgk-rs/about-us/fgk-rs-ltd/)
- [FGK Representative Service Ireland Ltd](https://fgk-group.com/fgk-rs/about-us/fgk-representative-service-ireland-ltd/)
- [FGK Representative Service BV](https://fgk-group.com/fgk-rs/about-us/fgk-rs-bv/)
- [FGK Representative Service Ireland Ltd\.](https://fgk-group.com/fgk-rs/about-us/fgk-representative-service-ireland-ltd/)
- [FGK Representative Service Ltd\.](https://fgk-group.com/fgk-rs/about-us/fgk-rs-ltd/)

## About Us \- FGK PV
- [Kontakt](https://fgk-group.com/fgk-pv/about-us/contact/)
- [Contact](https://fgk-group.com/fgk-pv/about-us/contact/)
- [Management / QPPV](https://fgk-group.com/fgk-pv/about-us/management-qppv/)
- [Management / QPPV](https://fgk-group.com/fgk-pv/about-us/management-qppv/)

## About Us \- FGK CRO
- [Partner](https://fgk-group.com/fgk-cro/about-us/partner/)
- [Geschäftsführung](https://fgk-group.com/fgk-cro/about-us/management/)
- [Management](https://fgk-group.com/fgk-cro/about-us/management/)
- [Dr\. August Wolff GmbH \& Co\. KG](https://fgk-group.com/fgk-cro/about-us/references/dr-august-wolff-gmbh-co-kg/)
- [Becton Dickinson](https://fgk-group.com/fgk-cro/about-us/references/becton-dickinson/)

## Services \- FGK RS
- [SME\-Status](https://fgk-group.com/fgk-rs/services/sme-status/)
- [Orphan Medicinal Products \(Drugs\)](https://fgk-group.com/fgk-rs/services/orphan-medicinal-products-drugs/)
- [SME Status](https://fgk-group.com/fgk-rs/services/sme-status/)
- [Arzneimittel für Seltene Erkrankungen](https://fgk-group.com/fgk-rs/services/orphan-medicinal-products-drugs/)
- [Marketing Authorization](https://fgk-group.com/fgk-rs/services/marketing-authorization/)

## Services \- FGK PV
- [Pharmacovigilance Services for Pharma, Biotech \& Med\-Device Companies](https://fgk-group.com/fgk-pv/services/pharmacovigilance-services/)
- [Responsible Person](https://fgk-group.com/fgk-pv/services/responsible-person/)
- [List of services](https://fgk-group.com/fgk-pv/services/list-of-services/)
- [Quality System setup](https://fgk-group.com/fgk-pv/services/quality-system-setup/)
- [Daily operation](https://fgk-group.com/fgk-pv/services/daily-operation/)

## Services \- FGK CRO
- [Erfolgreiches klinisches Studiendesign](https://fgk-group.com/fgk-cro/services/clinical-trial-biostatistics/clinical-trial-design/)
- [CDISC Compliance](https://fgk-group.com/fgk-cro/services/clinical-data-management/cdisc-compliance/)
- [CDISC Compliance](https://fgk-group.com/fgk-cro/services/clinical-data-management/cdisc-compliance/)
- [Clinical Trial Biostatistics](https://fgk-group.com/fgk-cro/services/clinical-trial-biostatistics/)
- [Data Management](https://fgk-group.com/fgk-cro/services/clinical-data-management/)

## Expertise \- FGK PV
- [Medical Devices](https://fgk-group.com/fgk-pv/expertise/medical-devices/)
- [Medizinprodukte](https://fgk-group.com/fgk-pv/expertise/medical-devices/)
- [Arzneimittel](https://fgk-group.com/fgk-pv/expertise/medicinal-products/)
- [Medicinal Products](https://fgk-group.com/fgk-pv/expertise/medicinal-products/)

## Expertise \- FGK CRO
- [Dermatologie](https://fgk-group.com/fgk-cro/expertise/dermatology/): Klinische Studien in der Dermatologie erfordern breites Fachwissen im Bereich bildgebender Verfahren\. FGK hat eine Vielzahl dermatologischer Studien in allen klinischen Phasen durchgeführt\.
- [Dermatology](https://fgk-group.com/fgk-cro/expertise/dermatology/): Clinical studies in dermatology demand expertise in imaging tools\. FGK has conducted a great number of dermatology studies of all clinical phases\.
- [Oncology](https://fgk-group.com/fgk-cro/expertise/oncology/): Numerous clinical trials spanning a broad variety of indications have made FGK an international renown expert CRO in oncology studies\.
- [Pediatric Diseases](https://fgk-group.com/fgk-cro/expertise/pediatric-diseases/): Our CRO services for pediatric clinical trials\. Compliant and patient\-centered\.
- [Hepatic Diseases](https://fgk-group.com/fgk-cro/expertise/hepatic-diseases/): We support sponsors with the development of new treatments for hepatic diseases and have performed clinical trials in diverse liver conditions\.

## Optional
- [Sitemap index](https://fgk-group.com/sitemap_index.xml)