NOVA-CRU, is the preferential point-of-contact for the planning and set up of clinical trials within CEDOC, NOVA Medical School and associated investigators. NOVA-CRU is currently accompanying several phase II and III Clinical Studies, both within and outside the NOVA Medical School environment. NOVA-CRU has expertise on GCP and medical monitoring, clinical trial management, medical writing, protocol development and clinical trial submission. NOVA-CRU is currently developing partnerships within academia, aiming to broaden the scope of offered services to Pharmacovigilance, Data Management, and Biostatistics.
NOVA-CRU offers services on clinical trial submission to regulatory and other competent authorities, including Ethics Committees and the National Data Privacy Agency. NOVA-CRU develops its work within the Portuguese and European legal framework and the ICH-GCP guidelines on Good Clinical Research Practice. NOVA-CRU is a new body within CEDOC, aiming to accompany existing Clinical Research Projects and further develop know-how and expertise within NOVA Medical School. NOVA-CRU comprises a complete set of research skills and clinical experience at the service of the academic, biotech and pharma communities.
Main areas of expertise:
- Protocol Development: From Protocol Design and Feasibility to Protocol Approval.
- Start-up Phase: Submission to competent Authorities
- Clinical Trial Management: We manage your trial from protocol design through study close-out.
- ICH-GCP Monitoring: Monitoring according to ICH-GCP E6 Guideline
- Data Management, Data Cleaning, Data Analysis
For more information please visit the NOVA-CRU Webpage