Expanded Access requests can be a fire drill. We built a workflow tool to help.

Compassionate use requests arrive unexpectedly and require a rapid, consistent and ethical response, often requiring input from multiple stakeholders at both the sponsor and health care provider. To complicate matters, compassionate use requests may originate from overseas, where regulations may differ from those of the country of the recipient. As a result, it can be difficult to respond in a rapid and consistent manner. The process needs to be clear given the speed at which decisions must be made and the need to communicate about the request internally and externally.

In response to these challenges, we developed an easily configurable workflow tool that creates a checklist to walk each stakeholder through the steps they need to complete. 

The workflow is configured to conform to your company’s Standard Operating Procedure(s) (SOP) and, combined with the regulatory requirements of the country from which the request originates, will generate a checklist that can be followed by both the internal request manager and the clinician team submitting the request.

Workflows accelerate turn around times for responding to Expanded Access requests

Automation

Each task in the checklist is linked to the action that needs to be taken,  including:

• Completing the medical history

• Uploading supporting documents

• Signing a contract

• Requesting shipment

• Providing progress reports

The tasks are grouped by stages. They are assigned to the appropriate person - and the system tracks when they are completed and by whom.  Once all the tasks in a group are complete, the system releases the next set of items. 

Physicians and their staff can log in and work directly on a case, collaborating with the team at the life science company, so that everyone can complete the necessary steps quickly.  Users receive notifications when a task is assigned to them or is overdue, ensuring that items don’t get dropped.

Flexibility

It’s easy to create multiple workflows and associated forms, so the sponsor can customize the process and data gathered by drug, program or country.

The workflow is dynamic, allowing any user to make adjustments to the steps in real-time. For example, if a medical reviewer needs lab results not included initially as a workflow step a pharma user can easily inject a new task into the workflow without missing a beat.

Video of creating a new MedaSystems workflow task.

Risk-reduction

Because workflows require that tasks be completed in a specific order, following company SOPs, and restrict progress until all the required predecessors are complete, it ensures that steps are not missed or skipped. 

To learn more about workflows, checklists and how our software can improve your process, reach out to request a demo.