Scope International
Independent, full-service contract research organization (CRO) headquartered in Mannheim, Germany. Founded in 2000, the company operates multiple European offices and provides end-to-end clinical development and consulting services across phases I–IV. Core activities include clinical operations, data management, biostatistics, safety/pharmacovigilance, regulatory support, medical writing and integrated eClinical systems. The organisation maintains a centralized quality management function, a global training management capability, and explicit processes for ATMP studies, therapeutic-area feasibility and patient recruitment. Data protection and GDPR compliance procedures are documented for web and operational data processing.
Industries
Nr. of Employees
large (251-1000)
Scope International
Mannheim, Baden-Wurttemberg, Germany, Europe
Products
Full-service contract research organization (CRO) for Infectious Diseases studies
SCOPE International AG is a full-service CRO specializing in clinical trials for infectious diseases, offering expert leadership and a vast network of experts and key opinion leaders in the field.
Biostatistics & SAS Programming
Comprehensive biostatistics and SAS programming services for clinical and post-marketing studies, covering study planning, statistical analysis, and reporting.
Strategic Development
SCOPE offers strategic development services for drugs, biologics, and combination therapies to minimize development delays and costs, and to strategically plan every step of clinical trials with regulatory expertise.
ATMP Clinical Trial Services
SCOPE International AG provides comprehensive clinical trial services for Advanced Therapy Medicinal Products (ATMP), including project management, clinical monitoring, regulatory affairs, data management, EDC programming, safety management, pharmacovigilance, medical monitoring, and statistical programming and analysis.
BSI eTMF
Electronic Trial Master File solution integrated directly with BSI CTMS, providing efficiency gains by synchronizing documents and metadata instantly.
Medical Writing
Experienced medical writers cover all documentation and reporting needs, including clinical trial protocols, amendments, development safety update reports, and integrated clinical study reports, delivering high-quality documentation within tight deadlines.
Full-service contract research organization (CRO) for Infectious Diseases studies
SCOPE International AG is a full-service CRO specializing in clinical trials for infectious diseases, offering expert leadership and a vast network of experts and key opinion leaders in the field.
Biostatistics & SAS Programming
Comprehensive biostatistics and SAS programming services for clinical and post-marketing studies, covering study planning, statistical analysis, and reporting.
Strategic Development
SCOPE offers strategic development services for drugs, biologics, and combination therapies to minimize development delays and costs, and to strategically plan every step of clinical trials with regulatory expertise.
ATMP Clinical Trial Services
SCOPE International AG provides comprehensive clinical trial services for Advanced Therapy Medicinal Products (ATMP), including project management, clinical monitoring, regulatory affairs, data management, EDC programming, safety management, pharmacovigilance, medical monitoring, and statistical programming and analysis.
BSI eTMF
Electronic Trial Master File solution integrated directly with BSI CTMS, providing efficiency gains by synchronizing documents and metadata instantly.
Medical Writing
Experienced medical writers cover all documentation and reporting needs, including clinical trial protocols, amendments, development safety update reports, and integrated clinical study reports, delivering high-quality documentation within tight deadlines.
Services
End-to-end operational management including feasibility, site selection, monitoring, site training, risk-based monitoring and project oversight.
CRF/eCRF design, EDC setup and configuration, data validation, reconciliation, database lock and data integration from multiple sources.
Statistical design and advice, sample size calculations, SAPs, interim and final analyses, and production of SDTM/ADaM datasets and TLFs.
Full range of drug safety services including SAE case handling, medical review, expedited and periodic reporting, safety database management and signal detection.
Regulatory strategy and submission support, CTIS/EU Clinical Trials Regulation expertise, local and central approval management and reporting during and after studies.
Preparation of protocols, amendments, ICFs, CSRs, DSURs, IBs, PIPs and lay summaries in line with regulatory expectations.
End-to-end operational management including feasibility, site selection, monitoring, site training, risk-based monitoring and project oversight.
CRF/eCRF design, EDC setup and configuration, data validation, reconciliation, database lock and data integration from multiple sources.
Statistical design and advice, sample size calculations, SAPs, interim and final analyses, and production of SDTM/ADaM datasets and TLFs.
Full range of drug safety services including SAE case handling, medical review, expedited and periodic reporting, safety database management and signal detection.
Regulatory strategy and submission support, CTIS/EU Clinical Trials Regulation expertise, local and central approval management and reporting during and after studies.
Preparation of protocols, amendments, ICFs, CSRs, DSURs, IBs, PIPs and lay summaries in line with regulatory expectations.
Expertise Areas
- Clinical trial management (Phases I–IV)
- Pharmacovigilance and safety reporting
- Clinical data management and eClinical system integration
- Biostatistics and validated statistical programming
Key Technologies
- Clinical Trial Management System (CTMS)
- Electronic Trial Master File (eTMF) systems
- Electronic Data Capture (EDC), ePRO and eCOA
- Automated safety reporting platforms
News & Updates
Company 25th anniversary reflecting on growth to 12 locations, over 220 employees and more than 300 studies; commentary on customer focus, independence and future priorities including decentralized trials and AI-driven analytics.
Report on UK-based CRAs conducting multiple site visits across the UK to ensure GCP compliance and site quality.
Announcement regarding improved TMF/document management processes through integration with a preferred eTMF provider and API connectivity to the company's CTMS to reduce setup times and maintenance costs.
Company 25th anniversary reflecting on growth to 12 locations, over 220 employees and more than 300 studies; commentary on customer focus, independence and future priorities including decentralized trials and AI-driven analytics.
Report on UK-based CRAs conducting multiple site visits across the UK to ensure GCP compliance and site quality.
Announcement regarding improved TMF/document management processes through integration with a preferred eTMF provider and API connectivity to the company's CTMS to reduce setup times and maintenance costs.