ECSOR
Clinical research organization providing integrated services across pharmaceutical, biopharmaceutical and medical device development. Offers end-to-end clinical development support (Phase I–IV), regulatory submission support, pharmacovigilance, medical writing, data management and electronic data capture, clinical monitoring and investigator network services. Provides project management, biostatistics, feasibility and patient recruitment services for national and international studies.
Industries
Nr. of Employees
small (1-50)
Products
ECSOR EDC Team
Fully integrated, flexible, comprehensive electronic data capture solutions for the management of clinical data, offering customized eCRFs and e-Platforms with high quality standards.
Eudravigilance platform (EVWEB)
EVWEB is designed for Small and Medium Size Enterprises (SMEs) lacking a fully ICH E2B (R2) compliant pharmacovigilance system. It provides tools including a version of the MedDRA dictionary for secure electronic reporting to the EMEA and Competent Authorities in the EEA.
Recruitment Flyers
Flyers posted in medical offices to support patient recruitment efforts for clinical trials.
CRA Placement
Service offering well-matched Clinical Research Associate (CRA) in/outsourcing or permanent placements to meet the needs of qualified CRAs and clients in the pharmaceutical sector.
CRA Training
6-day group program designed for new Clinical Research Associates to provide knowledge and practical skills needed to effectively begin work in the pharmaceutical sector, covering regulations, good clinical practices, and monitoring responsibilities.
GCP Training (Good Clinical Practices)
1-day group program providing intensive training for an in-depth understanding of clinical research processes, roles, responsibilities, and regulatory requirements, including ICH-GCP guidelines.
ECSOR EDC Team
Fully integrated, flexible, comprehensive electronic data capture solutions for the management of clinical data, offering customized eCRFs and e-Platforms with high quality standards.
Eudravigilance platform (EVWEB)
EVWEB is designed for Small and Medium Size Enterprises (SMEs) lacking a fully ICH E2B (R2) compliant pharmacovigilance system. It provides tools including a version of the MedDRA dictionary for secure electronic reporting to the EMEA and Competent Authorities in the EEA.
Recruitment Flyers
Flyers posted in medical offices to support patient recruitment efforts for clinical trials.
CRA Placement
Service offering well-matched Clinical Research Associate (CRA) in/outsourcing or permanent placements to meet the needs of qualified CRAs and clients in the pharmaceutical sector.
CRA Training
6-day group program designed for new Clinical Research Associates to provide knowledge and practical skills needed to effectively begin work in the pharmaceutical sector, covering regulations, good clinical practices, and monitoring responsibilities.
GCP Training (Good Clinical Practices)
1-day group program providing intensive training for an in-depth understanding of clinical research processes, roles, responsibilities, and regulatory requirements, including ICH-GCP guidelines.
Services
End-to-end support for clinical development from protocol design through regulatory submission and study conduct (Phase I–IV).
Preparation of IBs, IMPDs, clinical protocols, clinical study reports and CTD modules for regulatory submissions.
Database creation and administration, data entry and cleaning, remote database monitoring, customized eCRFs and web-based EDC deployments.
CRA placement, CRA coaching, classroom and practical CRA training and GCP training programs.
Adverse event handling, narrative writing, PSUR and ASR preparation, risk management planning and support for electronic reporting to regulatory safety systems.
Sample size and power calculations, SAP creation, statistical analyses and audit of statistical results.
End-to-end support for clinical development from protocol design through regulatory submission and study conduct (Phase I–IV).
Preparation of IBs, IMPDs, clinical protocols, clinical study reports and CTD modules for regulatory submissions.
Database creation and administration, data entry and cleaning, remote database monitoring, customized eCRFs and web-based EDC deployments.
CRA placement, CRA coaching, classroom and practical CRA training and GCP training programs.
Adverse event handling, narrative writing, PSUR and ASR preparation, risk management planning and support for electronic reporting to regulatory safety systems.
Sample size and power calculations, SAP creation, statistical analyses and audit of statistical results.
Expertise Areas
- Clinical trial management
- Regulatory affairs and CTD preparation
- Pharmacovigilance and safety reporting
- Electronic data capture and clinical data management
Key Technologies
- Web-based electronic data capture (EDC)
- Custom eCRF design
- Online randomization
- Clinical database design and administration
News & Updates
Publication on safety and efficacy of a recombinant hepatitis E vaccine in The New England Journal of Medicine.
Reported involvement in more than 160 national and international clinical studies across diverse therapeutic areas.
Network of approximately 120 investigators trained in clinical research (as stated in added-values).
Publication on safety and efficacy of a recombinant hepatitis E vaccine in The New England Journal of Medicine.
Reported involvement in more than 160 national and international clinical studies across diverse therapeutic areas.
Network of approximately 120 investigators trained in clinical research (as stated in added-values).