Study Software AlcedisTRIAL
AlcedisTRIAL is the software package for clinical research! Clinical trials are individual – and the same therefore has to go for the study software used. Our Study Software AlcedisTRIAL is based on a validated development environment, namely the Alcedis Framework. It is built as modular system in which each single component was thoroughly tested and validated. The AlcedisTRIAL Software will thus be perfectly adapted to the requirements of your study. This procedure significantly minimizes development time and costs and results in a secure and robust application. Clinical trials are complex. Many work steps, many fields of responsibility and many players! One of the reasons our Study Software AlcedisTRIAL is so successful is that we have succeeded in implementing all these processes and roles into one single software. AlcedisTRIAL can be accessed worldwide at any time from the internet and be used without installing any further software on the user’s computer. The Single Sign-On Principle ensures that our users are able to manage all AlcedisTRIAL Systems with one single user name and password – no matter whether as investigator, project manager or monitor for one or any number of studies.
AlcedisTRIAL – CTMS
The CTMS (Clinical Trial Management System) is the solid core of each AlcedisTRIAL Study Software. The AlcedisTRIAL – CTMS implements all administrative processes required for the conduct of a clinical trial. The module-based concept of AlcedisTRIAL – CTMS also allows flexible adaption to study-specific requirements. The functional scope of the CTMS systems available on today’s market differs significantly. AlcedisTRIAL – CTMS is committed to implementing all working procedures and collected data required for the conduct of a clinical trial. AlcedisTRIAL – CTMS basically implements the following functions: User Management; Case Report Form (CRF) Tracking; Clinical Supply Tracking; Reporting; Payment Tracking; Document Tracking; Data exports (e.g. E2B or customer-specific).
AlcedisTRIAL – eCRF
The eCRF (electronic Case Report Form) is the study-specific and extremely flexible part of our AlcedisTRIAL Study Software. Here we offer a bespoke modular-based EDC solution.
AlcedisTRIAL – Plugins
Many projects feature identical processes and tasks. Based on our longtime experience and the Alcedis Framework, we have developed ready-made plugins for this. Advantageous for the operator is the consistent surface with the result of comfortable handling. Furthermore, the development times are of course shortened. The monitoring plug-in, for example, offers all functions to picture the monitoring of a study clearly and effective. From managing monitoring visits to query management, the communication with Data Management and the study site to the automatic generation and submission of reports. Another very effective plug-in we developed for the pharmacovigilance. It provides all functions to document the delicate duties in this field. From capturing and identifying all safety relevant events over tracking and classification to reporting procedures and notifications to authorities and investigators.
AlcedisTRIAL – Validation
Our Study Software AlcedisTRIAL has been developed for application in clinical studies and non-interventional studies. All components are validated pursuant to GAMP 5, the Guideline for the validation of computer-based systems applicable and accepted as international industry standard for all GxP areas. All AlcedisTRIAL systems are FDA 21 part 11 compliant. The validation of our Study Software AlcedisTRIAL is based on a qualified infrastructure, our competent staff and a fully documented lifecycle for each component of AlcedisTRIAL such as our Alcedis Framework, CTMS or a project-specific eCRF. All changes to AlcedisTRIAL – Study Software are implemented using a controlled change management, so that the systems are kept valid over their full lifecycle.
AlcedisTRIAL – Mobile
These days, mobile software systems have become a well-established part of our IT world – this also goes for clinical research. In order to adapt to this trend, we develop innovative components for our Study Software AlcedisTRIAL. These allow working on forms or calling up reports by mobile devices like smartphones or tablets. This way, it is for example possible for the study participant to contribute their own study data, for instance declarations concerning quality of life, directly to the central study database via smartphone. And for project managers a quick glance at current key numbers and the course of study is the ideal preparation on their way to the next meeting.
AlcedisACADEMY Training Software
The training software AlcedisACADEMY is the perfect online platform to impart your individual issues to your target audience. Replenishing AlcedisVISION – live conferences – AlcedisACADEMY is the platform for self-study. The training software AlcedisACADEMY can be utilized as stand-alone solution, as for example for scientific further education or in connection with the study software AlcedisTRIAL. Specific training contents in the context of studies are patients’ safety, notification requirements, the structure of the study protocol as well as the documentation. The trainings can be completed with test and certificate. The test questions and answers can be created flexibly and combined accidentally. All training papers can be provided in established formats like PowerPoint. You want more? No problem – you may employ the training software AlcedisACADEMY as independent CME portal, if you wish to offer regular further education as a service feat to your clients.