Full computerization of a clinical trial
The acceptance and adoption of new technologies has made the complete management of clinical trials in RDE (Remote Data Entry) mode possible by exploiting broad band (ISDN, ADSL) Internet connection.
In practice, any activity required by participants for clinical trials (centres, CRO/Sponsor, Monitor) can be performed through an application available online and accessible via a specific Internet address.
This solution allows for the centralization of information and activities directly within the Internet site devoted to the trial (documents, data, statistics, reports, alerts, etc.). Through the activation of particular analysis tools, it is possible to obtain data in real time (regulatory situation, randomization progression, etc.). Another unquestionable advantage is the assurance of data quality and safety. Within the platform there are various programmes designed to monitor the quality of data written in electronic formats. These electronic formats undergo a series of controls (logical and plausible), certifying their quality before being stored.
Data safety is ensured through a series of software (data mirroring, alerting systems, database architecture, etc.) and hardware (cartridge full backup, hot swap hard-disk with raid 5 system, etc.) high quality service devices.
Another advantage of this software is data access. There are various access profiles (user, administrator, etc.), each of which are authorized to display specific information for tailored management.This clinical trial management mode allows one to analyze any phase of the trial and data in the database, due to an automated system the need to forward data is no longer required.
The method of approach used in the platform design phase is best characterized by having balanced the exigency to implement the application according to “Good Clinical Practice” and ensuring it is user friendly and safe, a need based on feedback from clinical researchers.
The computerization of most typical activities in research projects, not limited only to the clinical data input phase, allows us to define e-Clinical as an ERP (Enterprise Resource Planning) advanced system.
The platform is structured with specific sections dedicated to clinical data management and implementing processes for:
- Sites data and participant investigators’ data
- Integrated communication system (multiple videoconference, messages, etc.)
- Notice board for communications to be sent to all sites
- Documents useful and common to every centre
- The protocol of the trial
- Data files (in electronic format)