Medical Need Programs

15 December 2018

Past the Early Temporary Authorization (ETA)

We digitize the entire workflow of the Medical Need Program (MNP) or Compassionate Use Program (CUP) and because of that save precious time for pharmaceutical industry’s sponsors as well as health-care professionals.

Registration of doctors and education nurses 

Before a doctor is able to participate in your Medical Need Program or extensive access programs via our Remecare web portal, he or she should first create a user account. As soon as this user account has been activated, the doctor will receive an email with the log-in data.

Several health-care providers are able to get specific access on the basis of their role. This way, the access of education nurses can be made more restricted than doctors’ access. In Remecare, all performed actions are logged per user account.

Patient registration

To register patients, digital forms are available. If necessary, paper forms, like a signed informed permission, can be uploaded directly to the portal and linked to a specific patient.

Streamlining the workflow: email notifications & action center

Remedus Software Suite makes it possible to configure all email notifications and action centers you need. Every activity which requires ‘human interaction’ is regulated through the use of email notifications or reminders and actions on the web-based platform.

An email notification will automatically be sent to the specific sponsor of new patients who were registered by a health-care professional and need the approval of one or more sponsor employees.

Adjustable settings are available to determine which users should receive an email, for example all users who are linked to a site. Also available is a complete Audit Trail, to keep up with which emails have been sent (and to whom).

Reports & tables

Remedus offers a range of reports to which you have access:

  • Number of registered patients
  • Number of new patients
  • Length of time patients have been part of the program
  • Registration statistics per site
  • Number and types of side effects and discontinuations

Quality

Remedus is ISO 13485 certified (design and production of medical devices). Our product, Remedus Software Suite, is CE certified in accordance with the European directive concerning medical devices (93/42/EEG).

Share

Recent news

Read our latest news

RemeCare “M1 approved” by mHealthBelgium

Global

16 August 2019

RemeCare “M1 approved” by mHealthBelgium

RemeCare Oncology was one of the first four mHealth apps included in the validation pyramid of mHealthBelgium. This approval means…

Read more
RemeCare Candidate Prix Galien 2018

Global

29 May 2019

RemeCare Candidate Prix Galien 2018

RemeCare (consisting of a web platform and smartphone application) is intended for use outside the hospital and allows caregivers to…

Read more
Remecare-App validated as medical trusted app

Global

01 May 2019

Remecare-App validated as medical trusted app

After years of development work and medical trials, Remedus is proud to announce that its RemeCare mobile health app has…

Read more