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Provision of a CTMS (Clinical Trial Management System) for the KCE Trials programme

Tenders submission deadline: 19/06/2017 (13:00)

Provision of a CTMS (Clinical Trial Management System) software to manage clinical research as the sponsor of a study or as a participating site, and to oversee all studies in the KCE Trials programme as a funding body.
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In 2016, KCE launched a programme to fund pragmatic clinical trials focusing on clinical practice: the KCE Trials programme. The plan is to fund 5 to 10 major multicentre studies per year (with a global budget of 5 million euro in 2016 and 2017 and 10 million euro from 2018). The KCE will select and fund the studies but will not lead them, since the role of clinical study sponsor will be taken by the organisation (often a university hospital) and the research team who have proposed the trial and drawn up the research protocol.

KCE is seeking a CTMS-type (Clinical Trial Management System) IT-program (as a Software as a Service) to monitor the studies included in the KCE Trials programme and to facilitate collaboration between the sites and the various stakeholders.

The type of monitoring will depend on who is using the software and for what purpose:

  • for the local clinical research staff at a site participating in a study, it will facilitate the monitoring of the patient flows in that study (number of patients selected, randomised, who have finished the study or completed the study) and facilitate communication with the sponsor of the study including the possibility of uploading requested documents (e.g. training certificates, CVs, approvals, signature lists, etc.). If studies other than those financed by KCE Trials are entered into the system, it will provide a comprehensive overview of the progress of all clinical research in a hospital.
  • for the project manager of the study sponsor (who may or may not belong to a participating site), it will provide an overview of the progress of the study in the various participating sites and will help to plan the monitoring visits and check patient recruitment. It will also provide an easy and clear way for the sponsor to provide the sites with the latest versions of the key documents for the study (protocol, ICF forms, guidelines, approvals, data analysis plan, etc.).
  • for the KCE staff who manage the KCE Trials programme, it will provide access to real-time data on the status of all the KCE studies in progress and facilitate the production of status reports (Key Performance Indicators) for the programme. Only aggregated data on recruitment will be used for this purpose.

The software must comply with all the Belgian and European legal requirements on data protection. It has to allow to store patient identification codes, and these need to be accessible only to the person(s) who should have access to them e.g. the person(s) who have access to a particular study in a particular site (the clinical staff for a particular study at a study site).

In general, the IT solution must:

  • be compatible with the structure and organisation of Belgian hospitals (some hospitals have several sites) and be able to function in a non-hospital setting (e.g. for doctors from private practice participating in a study).
  • be efficient in terms of data collection and data standardisation (the data is entered into the software only once and is accessible to anyone involved in the study who needs it).
  • facilitate the communication between the various stakeholders (funding bodies, sponsors and researchers at the site(s)) of key information on the trials (key study documents) by serving as an easily accessible document repository and communication forum.
  • make it possible to distinguish between the studies in the KCE Trials programme and the other studies. In addition to managing the studies in the KCE Trials programme, the software may also be used by the site personnel to help manage their entire portfolio of commercial and non-commercial studies, as a sponsor and as a researcher at a participating site. The confidentiality of such studies must be respected by KCE: with the latter only receiving access to the aggregated data (and not the patient data) of the studies that are funded by the KCE Trials programme.

This procurement also covers the maintenance and support services, the training and the consultancy relating to this software.

In notices, the term 'hospital' is understood within the meaning of the coordinated law on hospitals and other healthcare institutions (Law of 10 July 2008), i.e. a hospital corresponds to an approval number and may include several geographically separate sites. The KCE imposes a pricing model per hospital (irrespective of the number of users in that hospital, “site licence”). The price may, however, depend on the volume of use of the software by the hospital. The KCE will cover the price of the "basic" license of the software (the one covering a low use of the software in terms of data volume).

The selected software will be used in around fifty Belgian hospitals which will be participating in one or more studies financed by the KCE Trials programme. This deployment will be spread over 4 years. This number of hospitals is provided for information only. The KCE gives no undertaking regarding the total number of hospitals in which the software will be in use at the end of 4 years.

published on 11-05-2017