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.
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
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).