Configure your Clinical Study

Since the release of version 3.0, has been designed with a modular structure. Each module provides a set of specific functions and can be activated immediately, during the setup phase, or at a later time according to the specific requests of the study protocol.

A change management process is in place to guarantee that the validation status of the clinical trials is constantly valid.

Easy Study Setup

Choose the modules you want to enable and decide when you wan to activate new features

Designed by clinicians for clinicians

Standard Modules

In it is possible to activate a set of standard modules that cover all the functions required during the conduct of a clinical study.
There are modules specifically designed for patient management and others that allow the profiles involved to better optimize their work, always having complete control of what happens inside the study.

From clinical data to pharamcovigilance, from drug handling to protocol deviations, online coding of therapies and medical terms, laboratory normal ranges assignment and so on, everything has been designed to help you to conduct your study easily and efficiently.

Software development applied in clinical research

STUDY SPECIFIC MODULE can count on the presence of a team of expert programmers who, in addition to the technical knowledge of the platform, can boast an in-depth knowledge of clinical processes.
We are constantly developing new modules and new features that, after a careful and precise validation process, help your clinical study to achieve the success and compliance objectives that are expected.

Let’s define together the features you need to integrate with your ecosystem and rely on our experts who will be able to meet your needs.

  • Simple and guided interface
    The user is always accompanied at every stage of the process
  • Online data validation
    The consistency of the data is guaranteed by the validation processes
  • Online queries and protocol deviation
    Queries, as well as PDs, are integrated within the eCRF
  • Laboratory Normal Ranges
    The laboratory unit management process is automated and safely managed
  • Automatisms and notification
    The user is always aware of what is happening to the patients and what to do in the system

For the sites

A set of tools designed to help investigators and their staff during the data entry process

For the Sponsor

We know that the most critical aspect of a clinical study is the real-time management of the events that occur in it.

  • Online reporting module
    All modules share the same database, for this reason it is possible to take advantage of online reports that allow you to have complete control over every aspect of the clinical trial.
  • Document and newsletter
    It is possible to upload into the study portal all the documents necessary for the trial and the updated newsletters.
  • Automatic email
    Every important event within the clinical study is notified to all profiles involved. Each user must know the progress of the study and be able to intervene to improve processes
  • And much more
    Contact us to better understand how to make your trial a successful process
  • Online coding
    Data Managers can use the online coding module for immediate coding of Therapies or Medical Terms using the latest available version of medical dictionary
  • SDV and remote monitoring
    Clinical monitor are able to apply the Source Data Verification flag to each items of the eCRF. Using the remote monitoring flag it is possible to have a complete control all over the study
  • Safety notification
    The pharmacovigilance user is notified on each serious events within the study. A specific PHV Query can be raised in order to ask for better clarification to the investigator. Automatisms and online check are available to guarantee that the notification is performed within the time foreseen by the regulatory requirements
  • Clinical trial overview
    Project Managers can use online reporting tools for study analysis and CRA allocations
  • Clinical evaluation of the patient
    Clinical Reviewer and Medical Monitor can use online tools to oversee patient’s status

For all the involved profiles provides 15 different standard profiles that can be customized according to the study needs