rene

René offers rich functionality to define each project´s planning, elaborate in a productive, organized and auditable way the project`s documentation (protocols, budgets, contracts, CRFs and other forms, etc), to carry the volunteer recruiting, the coordination of the agenda and the execution of studies with its electronic CRFs (Case Reports Forms) and in digitalized paper.

Its Process centered design makes it easier for doctors, auxiliaries, regulatory bodies, sponsors, and other users to work in a distributive way following the pre-established procedures, with real time traceability of all the activities and contents, version control, on-line monitoring and auditing for managers and sponsors.

Among it services it includes security, encrypting and audit trails in compliance with the ANMAT regulations, HIPAA recommendations and 21 CRF part 11 regulations from FDA.

It is a totally web-based software, very easy to use, which is implemented within minutes and ready to be used.

Planning

Planning, Participants and activities

For each project you can define the internal and external participants with its corresponding roles (such as coordinator, collaborator, auditor, etc.)

You can also define the plan itself with its stages and each of the activities that add up to the project, along with the permissions of each participant for each activity.

Unlike other traditional Project Management software, the project plan is integrated to the execution of the activities, and it updates automatically as the project moves forward.

It has precise and updated indicators of the project progress at anytime, it can compare the deviations between what was planned and reality in order to have solid estimations for the future.

Process centered approach

René is an innovative information system at the service of your clinical research project. It simplifies the regulatory compliance, improves the operational efficiency, offers traceability and auditing in real time, and more internal control and reliability.

It has been designed using a workflow model for each of the project activities. Each user has a workspace where they can receive and take the tasks assigned by the workflow engine according to the procedure defined.

This process layer allows an efficient multi-site management, offers real time traceability of each content and activity, and allows the authorized users to monitor and audit the status of each process, stopping or restarting activities and reassigning tasks