The Xavia SIDEC Clinical Trial Data Management System was designed with the objective of contributing to improve the design and conduct of clinical trials conducted at the Center for Molecular Immunology (CIM) in Cuba and associated clinical sites.
Since its inception, the CIM has developed a series of biomolecules for the treatment of different diseases. The basic research projects are focused on cancer immunotherapy, especially in the development of molecular vaccines, antibody engineering, cell engineering, bioinformatics and regulation of the immune response in the search for new products for the diagnosis and treatment of diseases related to the immune system.
Xavia SIDEC designs 100% of the clinical trials of this center. This is possible from the management of the studies and centers where the trials are carried out, management of the Data Collection Notebook (CRD) sheets, management of groups of subjects, general chronogram, stages and moments of follow-up of the study. It also allows to define rules for the validation of the fields of the CRD sheets.
The system has been deployed in all the country's provinces, and has not only reached the specialized level of hospitals, but it is also being used in primary health care units. The XAVIA SIDEC system enables CIM specialists, coordinators and researchers to carry out electronic data capture, eliminating double data entry during the conduct of clinical trials and allowing remote data transmission between the national network of hospitals and the CIM.
Currently, 32 clinical trials are being conducted through the electronic CRD, from Phase I to Phase IV trials with more than 820 patients included. Among the trials incorporated in the system is the CIMAvax-EGF vaccine in predictor lung Phase IV, approved in 176 sites in the country (35 hospitals and 141 polyclinics), where more than 500 researchers participate, which is considered one of the most complex research conducted to date in Cuba, with greater participation of doctors and clinical sites, and the first to be conducted in primary care services nationwide with the use of electronic CRD.
The development of XAVIA SIDEC for Cuba propitiates:
- Generate significant savings, enabling the acquisition of a software developed in the country, while ensuring support or maintenance without incurring large expenses for licenses or services.
- Comply with international standards of quality, safety and good clinical practices according to GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act).
- To increase the efficiency in the conduct of clinical trials in the CIM and other centers of the Scientific Pole, such as biotechnology companies, with the consequent impact on accelerating the development of several products and therefore increasing their competitiveness in the international market.
- Facilitate and rationalize the process of design and approval of the Data Collection Notebooks.
- Provide greater security to the information.
- Standardize the information handled in clinical trials allowing the coding of treatments and adverse events through integrated dictionaries.
- Eliminate double data entry. The data are entered directly by those who collect them, being also responsible for them, which reduces the occurrence of errors, missing and inconsistent data and the number of non-evaluable patients.
- Allow immediate and updated access to the clinical trial development status.
- Facilitate the flow of information between the entities that conduct the trial and allows the tracking of records related to these communications.
- Facilitate the work of the monitor as it allows the optimization of the monitoring process by reducing the number of visits required to inclusion sites, as well as the time required in them.
- Help specialists from different clinical sites to reduce errors in the collection of patient data.
- To reduce the real time and costs in the conduction of clinical trials, thus accelerating the obtaining of drugs in less time.
- Contribute to the accurate development of the trials, with a high degree of validity in the research, which allows us to estimate with veracity the impact of the same on the health of patients.
- Contribute, with the efforts made by the country, to the computerization of public health, helping to improve the quality of life of its inhabitants.
Based on the positive results obtained in the use of this system, a joint decision has been made with the highest management of BioCubaFarma to generalize the XAVIA SIDEC system to all the institutions that conduct clinical trials in the country. The implementation process has begun at the Finlay Vaccine Institute and the Center for Genetic Engineering and Biotechnology, with the clinical trials of greatest impact and importance.
Xavia SIDEC 3-0 is available from https://sirec.uci.cu/gehos.
Different roles and privileges have been defined to access with the following credentials (user-password): coordinador-coordinador, gerente-gerente, estadistico-estadistico, promotor-promotor, investigador-investigador.