Services and Rates | Clinical Research and Clinical Trials (UBICEC)
Services
UBICEC offers services to researchers wishing to conduct clinical research studies in their role as sponsors, in compliance with legislation and Good Clinical Practice (GCP) standards. Below is a detailed description.
Clinical Trial Services Request
1. Methodological and Statistical Support
- Methodological advice for designing research protocols for observational, experimental and quasiexperimental studies
- Statistical advice and analysis
- Design, development and validation of CRFs
- Digitalisation of CRFs
2. Clinical Trial StartUp
- Identification and selection of sites
- Preparation and submission of general documentation and trial applications to regulatory agencies
- Payment of fees (CEIm and/or AEMPS)
- Clinical trial registration and registry maintenance
- Clarifications and amendments requested by regulatory agencies and/or ethics committees
- Certification and batch release of investigational medicinal products
- Preparation of the monitoring plan
- Collection of signatures and submission to the sponsor
- Request for clinical trial insurance policy (selection, contracting and processing)
- Management of contracts with sites
- Preparation and maintenance of the sponsor and investigator files
- Drafting or adaptation of patient information sheets and informed consent forms
3. Clinical Trial Conduct
- Project management
- Monitoring
- Study coordination
- Financial and administrative management of payments
- Nursing
- Biological sample management
- Data management
- Economic management of the trial or project
4. Clinical Trial Completion and CloseOut
- Resolution of queries and database lock
- Closeout visits
- Preparation of the final study report
- Medical writing
5. Pharmacovigilance
- Implementation plan for pharmacovigilance activities
- Updating safety information documentation
- Reconciliation of SUSARs/AEs
- Preparation and submission of safety reports