Services

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