GCP-Service International Ltd. & Co. KG
Clinical research organization (CRO) providing clinical trial services for medicinal products and medical devices. Services include full-service and functional service provider models, acting as sponsor or legal/authorized representative in the EU, eClinical data capture and remote monitoring, biostatistics and statistical monitoring, TMF/eTMF management, site feasibility and selection (with emphasis on Central and Eastern Europe), medical writing, and training on clinical and regulatory topics. Operates globally and supports ISO 14155/MDR requirements for medical device investigations.
Industries
N/A
Nr. of Employees
small (1-50)
GCP-Service International Ltd. & Co. KG
Services
End-to-end management of clinical trials including project management, clinical operations, monitoring, TMF management and regulatory submissions.
Supply of specific clinical functions (e.g., monitoring, data management, biostatistics) as standalone services.
Assumption of sponsor responsibilities for companies unable to act as sponsor, including oversight, regulatory interactions, and ensuring trial conduct and patient safety.
Legal Representative services for drug studies and Authorized Representative services for medical device studies in the EU; representation in selected non-EU jurisdictions.
Data protection representation and GDPR compliance support for clinical trials, including breach handling and preparation/review of compliant study documentation.
Statistical planning, sample size/power calculations, ongoing central/statistical monitoring, and graphical data presentation.
End-to-end management of clinical trials including project management, clinical operations, monitoring, TMF management and regulatory submissions.
Supply of specific clinical functions (e.g., monitoring, data management, biostatistics) as standalone services.
Assumption of sponsor responsibilities for companies unable to act as sponsor, including oversight, regulatory interactions, and ensuring trial conduct and patient safety.
Legal Representative services for drug studies and Authorized Representative services for medical device studies in the EU; representation in selected non-EU jurisdictions.
Data protection representation and GDPR compliance support for clinical trials, including breach handling and preparation/review of compliant study documentation.
Statistical planning, sample size/power calculations, ongoing central/statistical monitoring, and graphical data presentation.
Expertise Areas
- Clinical trial management
- Regulatory compliance and EU representation
- eClinical systems and electronic data capture
- Biostatistics and statistical monitoring
Key Technologies
- Electronic data capture (eCRF)
- Electronic patient-reported outcomes (ePRO/eCOA)
- Electronic trial master file (eTMF)
- Clinical trial management systems (CTMS)
News & Updates
Reported completion or conduct of more than 600 clinical studies.
Reported 100% successful audits/inspections in the last three years (as stated).
Conducts trials through network partnerships in more than 60 countries.
Reported completion or conduct of more than 600 clinical studies.
Reported 100% successful audits/inspections in the last three years (as stated).
Conducts trials through network partnerships in more than 60 countries.