The performance of software tools is a determining factor in the management of clinical trials and ultimately the efficiency and security of medication, material and therapeutic products before their release onto the market. It’s vital to make the right choice.
Software tools for clinical studies clearly constitute an essential component for improving the reliability and the outcome of the process. Their performance determines the efficiency and security of medication, material and therapeutic products before their release onto the market. In fact, the software management tools for clinical trials (CTMS or Clinical Trial Management System) reinforce procedures and practices by eliminating individual approaches. For that reason, they enable access control and user roles, as well as frameworks in order to gain time in data capture and consolidation.
Gfi eTrialManager®: the answer to all these requirements
Developed in close collaboration with pharmaceuticals companies, Gfi eTrialManager® is aimed at all the structures and stakeholders involved in clinical research. It fulfils all their administrative, scientific, statutory and financial requirements. In 20 years it has gained the experience to develop a functional and technological tool that is simple to use, entirely configurable, with a user-friendly graphic interface and with functionalities for optimal performance. Finally, it saves a significant amount of time in the management of clinical data and results!
100 standard editions and numerous functionalities
Over 100 standard editions are available (contacts, countries, studies, centres, patients, financial contracts…), as well as optional modules.
Gfi eTrialManager® offers numerous functionalities, including:
- Security and traceability on different levels (department, role, study, country, dates), with password, management of external participants, configurable audit trail;
- A contact database with management of duplicates, monitoring communications, history of participation, criteria search;
- Management of all the study data (n°, type, status, defined therapeutic area…);
- Visit schedules per survey and applicability (by survey, centre, country);
- Recruitment schedule with planning, setup of one or several centres for each of the surveys and optimal visibility with regards to the forecasts;
- Description of the staff associated with the surveys according to each level of intervention, detailing the functions, periods of activity…;
- Detailed monitoring of exchanges with the contacts and the staff involved in the surveys;
- Monitoring of problems, including an overview;
- Full management of all the centres’ data: regulatory, financial, scientific;
- Management of patients: planned and real dates of visits, monitoring elements, returned and collected ‘Investigational products’ (calculation of observance), AE, SDVs, CRFs and DCFs;
- Trend charts on user-monitored data.