CIIC provides solutions for:
Protocol Design for clinical research studies
1. Advice and development of clinical research protocols, bibliographical research, study design and methodological advice
2. Interactive meetings with researchers and project managers
Clinical Trials Data Management
1. Design and development of CRFs (Case Report Forms), parametrization of each protocol through data capture
2. Creation of databases and electronic CRF (eCRF). The eCRFs allows to increase the productivity of all the professionals involved in a Clinical Trial
3. Implementation and development of software for project management:
Restricted access to study participants
Query, update and validation tools
Automatic alerts for errors in CRFs
Integrity checking
Automatic email alerts to researchers when errors occur compliance
Traceability of changes (audit trail)
Creation of Reports and Graphs
Remote Access to a single database
Creation of discussion forums and messaging services
Staff Training and monitoring of clinical studies
1. Organization and team training in Clinical Research
2. Review and control of regulatory documentation required by local and international regulations, based on the ICH-GCP
3. Review of informed consent and source document of each patient enrolled in the study
4. Project periodic control reports
Statistical analysis of databases
1. Calculation of the sample size and statistical power of the study
2. Exploratory data analysis
3. Application of statistical techniques
4. Meta – analysis
5. Statistical quality control
6. Final analysis of results, interpretation and publications support
Scientific writing and publishing articles
1. Assistance and support for scientific publications