Although we refer to 'Medical Need Programs', the flexibility of our Portal allows handling other programs like 'Compassionate Use' or other 'Named Patient programs' in a similar way.
Before a Physician is able to participate in your Medical Need Program using our web Portal, a User-account will have to be created.
If all details of a participating Physician are known, the user can be pre-registred using the standard Administration tools.
As soon as the user account is activated, the physician will receive an email with the user authorization details.
Once a Physician is able to login to the Portal, online Forms are used to collect further information, like the address details of the Pharmacy department to which medication can be sent.
The same Form can be used to get a confirmation of Compliance with the requirements of the program.
Often the actual work of participating Physicians is taken over by Study Nurses. Ideally, Study Nurses will have their own login-account. This login account can be directly created by a Physician using an online registration process. Once the Study Nurse registration Form is saved, a user-record will be automatically created and the Study Nurse will receive an email with the user authorization details. Role-based access might limit the activities of Study Nurses compared to Physicians.
The portal's Visit Scheduler ensures that all relevant data is collected in a timely fashion.
The ability to have Edit checks ensure that any data collected is complete and correct.
Forms can be signed off as 'Draft' or 'Final'. Only when a Form is signed off as Final, any further actions be executed.
When needed, paper forms, like signed Informed consent, can be emailed directly into the Portal and are archived as digital copies.
Role-based, and user-based, rules ensures access to Forms & Data.
As a simple implementation, a rule can be set for Physicians to be able to 'create' & 'update' patient data, while Sponsor employees will only be able to 'view' patient data.
Or, if new patients who are included by a Physician need to be approved by a user(s) from the Medical department, you can have the 'Internal Approval form' to be:
- hidden from physicians,
- viewable by Sponsor Employees
- updateble by any user from the Medical Department
When needed, data-encryption can be used to add another layer of security to protect specific patient data. When data is encrypted, not even a Portal administrator will be able to read the information, nor is it available during an export of the data.
Each activity which requires 'human attention' is regulated by using email notifications.
If a new patient is entered by a Physician which requires approval by a Sponsor employee(s), an email Notification will be automatically sent to dedicated Sponsor employee(s) as soon as a Patient registration form is signed off by a Physician as 'Final'.
Flexible settings are available to define which users should receive an email, e.g. all users which are linked to a site. A full Audit Trail is available to track which emails have been sent (and to whom).
An integrated 'Task Center' is used to assist users with their daily workflow.
In this specific example each medication request had to be approved by the Medical Department. Therefore a Task was defined 'to approve medication requests'.
This Task was assigned to a number of dedicated users.
When needed, an email reminder can be sent on a regular basis (weekly) to remind user of any open Tasks.
One of the (many) advantages of going digital with a Medical Need Program is that all information is digitally available and can be used to create Reports & Charts.