As CRO we offer the following services:
Trial start up services
- Feasibility studies
- Regulatory support
- Protocol Design (or review)
- CRF Design (or review)
- Sites selection
- Submission to ethics committees
- National Regulatory Agencies applications
- Contracts Management
- Patient Informed Consent
- Investigators meeting
- Regulatory (other)
- Site Initiation Visit
- Study samples management
Project management & monitoring services
- Interim monitoring visits
- Project management
- Monitors coordination tool
- In-house (Telephone) monitorig
- Investigator Grant Management / payment management of sites
- Investigational Product accountability
- Monitoring visit reports
- Online Reports for sites
- Weekly / Monthly pdf Reporting to sites, Clinical Coordinators and Study Managers
- eData management QA & support (all the tools detailed in the phase 2 regarding to the data management)
Project closure services
- Queries resolution
- Site close out visit
- Regulatory and ethics comunicaction
- Trial Master File Closure
- Medical Writing
- Final report
- Regulatory review
Biometry services
- Sample Size Calculation. Bibliographic research to justify the assumptions of the sample calculus size & sample size calculus
- Protocol Statistical Plan. Specifications of the analisys populations and different analysis to be conducted: Tolerance, Security, secondary objectives and other sub-populations analysis
- Data Base (DB) design
- DB Validation
- Data verification
- Queries creation to detect major inconsistencies
- Final Statistic Report
- Data depuration, derived variables programming, tables & standard graphics creation (following the protocol analysis plan)
- Result Interpretation. Articles consultation and tables & graphics customization
and of course eCRFs, eTrials and CTMSs.