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ClinicalTrials is the web based Sinaptica IT platform aimed at clinical trials data capture. Thanks to ClinicalTrials clinical research can benefit from a dedicated highly performing IT tool, efficient and cost-effective, that guarantees secure data transfer meeting the needs of any kind of clinical study.
A web based access allows you to have data available online in real time streamlining workflow, data control and analysis. ClinicalTrials can be used with any web browser (Internet Explorer, FireFox, Safari, Opera) without installing any further software and without any hardware or operative system constraint.
ClinicalTrials characteristics make it a perfect tool within an international clinical trial environment:
- Bilingual version available (English - Italian).
- A web based platform for a worldwide access, as long as an Internet connection is available.
- It does not need to be installed: it is possible to activate centers and users in remote mode.
ClinicalTrials is a tool that offers full control and whole flexibility to manage clinical trials data. Thanks to its parametric structure it can be adapted to the needs of any clinical trial protocol. Indeed, you can generate and modify, completely on your own, eCRFs (electronic Case Report Forms) and its workflow, just as access profiles can be personalized according to the needs of any of the different actors playing a role in the study (Data Manager, Biostatistician, Investigator, System Administrator and Patient).
ClinicalTrials uses the HTTPS web data transfer protocol through the SSL code system at 128 bits that guarantees maximum data security and a security logic fully compliant with Italian Data Privacy regulations (196/2003); furthermore, it has been designed to adhere to GCP (Good Clinical Practice) and to specific requirements concerning Data Privacy within the clinical research field (24 July 2008 - Italian Data Protection Supervisor Guidelines).
 Download ClinicalTrials Presentation (2,6 MB)
Download ClinicalTrials User's Guide for Investigators (20,7 MB)
ClinicalTrials | Description
WORKING CYCLE
ClinicalTrials working cycle has been carefully designed and field-tested to streamline the steps that characterize clinical studies data capture. It provides Users with an efficient tool that allows them to fulfill their own role responsibilities in a more efficient way:
- Centers participation and patients pre-screening: creation and management of Users and Groups.
- Design and implementation of case report forms: eCRFs Templates design and creation (through which the logical time flow of the study is managed).
- Data capture: eCRFs creation and following workflow validation.
- Export: data export tools for migration of clinical datasets.
USERS AND GROUPS STRUCTURE
ClinicalTrials presents most flexible access and usage profiles management features thanks to a logical structure divided by Users and Groups.
This structure has been widely developed by Sinaptica IT and field-tested on the clinical case history ClinicOnline® where it has shown to be the only really efficient solution able to guarantee:
- Maximum flexibility.
- Real control of usage access levels.
- Accurate interoperability management.
ClinicalTrials system encompasses all needed actors in the conduction of a clinical trial: Data manager, Investigator, Biostatistician, Administrative manager and Patient.
MANAGEMENT OF THE CLINICAL STUDY LOGIC-TIME FLOW
ClinicalTrials lets you model and accurately manage the clinical study eCRF compilation flow in a flexible manner. This is made possible through the Time plan tool, developed and implemented by Sinaptica IT, that allows you to control the logic-time therapy flow through some simple eCRF Templates parameters.
Three coordinates in its eCRF Template define the exact position of a single form within the logic-time flow of the study:
- Time line: indicating a timeline where to position the form.
- Time slot: indicating the exact moment in time where we want the form to be created and filled-in.
- Posix: indicating the position where to place the form as regards to other forms with identical Time line and Time slot.
PARAMETRIC AND MODULAR STRUCTURE
ClinicalTrials is an extremely efficient platform to design clinical studies thanks to its parametric and modular structure. As a matter of fact, this comes to light when implementing case report forms and, in particular, once the so-named eCRF Templates are created.
Each eCRF Template is made of:
- Own parameters and Time plan checks parameters.
- Sections with Clinical Questions and Answers.
- Logic, range and edit Checks, which can be cross-field, cross-sectional, cross-form or even cross-study.
SECURITY
ClinicalTrials is an innovative tool inspired on a light infrastructure and on maximum operational security. It has been designed according to the following paradigms:
- Accessibility.
- Security.
- Operations data logging.
HIGHLIGTS
ClinicalTrials is a clinical studies data capture tool designed according to the paradigm of Efficiency, Efficacy and Economical services within the world of clinical research.
ClinicalTrials, designed and developed “in the field” thanks to the many years experience of Sinaptica IT in consultancy and technical support to organizations dealing with international clinical studies, combines a pragmatic approach with a long-lasting experience that reaches state of the art technology.
ClinicalTrials many highlights are attributed to its base architecture (web-based, parametric and modular, cost-effective) as well as to its particular solutions expressly designed and developed to reduce repetitive operations, as for example, the “clone” feature, that makes possible to track any event and to eliminate activities dealing with data entry of already existing data which is, very often, cause of error. This way, ClinicalTrials makes possible to free professional resources and economic funds keeping untouched the quality of work and scientific results.
Some important ClinicalTrials highlights come to light only when using the platform for a long time and in a continuous way. For example, it is worth of note the possibility of linking the logic-time flow to data captured in other clinical studies, or even of conducting statistical analysis on values coming from different studies thanks to the library to which different studies flow together. Even more, the possibility of creating an archive of eCRF Templates, Clinical Questions, Answer to these questions and Checks of any nature that can be reused as modules already available for future clinical studies.
ClinicalTrials is a living tool that is continuously being updated and developed by the department of Research and Development of Sinaptica IT, based on a continuous and profitable exchange of visions with final users.
All approved updates are released in real time free of charge, without any needed upgrade or installation on hardware.
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