Pharmaceutical Company: REMS Health Cloud Implementation

Background

According to the U.S. Food and Drug Administration (FDA), a Risk Evaluation and Mitigation Strategy (REMS) is a federally mandated drug safety program that can require certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Drugs that are under REMS control must meet certain requirements with respect to how the manufacturers manage communications and interactions between patients, health care providers, pharmacists and health care settings.

The client offers Risk Evaluation and Mitigation Strategy (REMS) services to help pharmaceutical companies comply with FDA drug development, launch and ongoing safety reporting requirements while ensuring patients have appropriate access to drugs and biologics. The client needed a contact center application to manage a REMS program for the drug Xiaflex. The drug is indicated for the treatment of adult patients with Peyronie’s disease (PD) and Dupuytren’s contracture (DC).

The Challenge

The client desired to move REMS from a custom developed full stack application to the cloud. To do so, they had to ensure that the application meets REMS standards along with 21 CFR part 11 requirements.

The application should meet following high level requirements:

• Receive forms by fax or mail, store the forms as images and should have capability to attach the images to respective stakeholder records within the application
• Tracking ability for all inbound/outbound communications for stakeholders who interact with the program
• Enroll Healthcare Providers (HCP) and Healthcare Settings (HCS) into the REMS program and map provider affiliations to healthcare settings
• Validate HCP and HCS enrollments by verifying all required information is received and required identifiers are provided and valid such as NPI, NCPDP, SLN and DEA number
• Manage escalations like invalid identifier, suspected noncompliance, duplicate identifier, sponsor escalations
• Capture potential adverse events, product complaints and medical information to report to manufacturer
• Manage all REMS requirements for the PD indication and manage the distribution list for DC indication
• Manage notifications related to enrollment like complete/incomplete notifications and other notifications like enrollment expiration, cancellation, deactivation, re-enrollment, affiliation changes

The Solution

Wilco Source assessed the client’s requirements and customized Salesforce Health Cloud to capture different stakeholder details including HCP (Healthcare Provider), HCS (Healthcare Setting), Patient, Pharmacy and AR (Authorized Representative) for the HCS. To meet requirements of 21 CFR Part 11, a Salesforce object specific audit trail was enabled for all fields. The contact center application was integrated with zPaper for incoming and outgoing fax communications. zPaper allowed the agents to view faxes as images in Salesforce and enabled them to easily attach these forms/documents to the stakeholder records.

Standard Health Cloud data repositories were used to capture stakeholder information and cases were created on and associated to stakeholder records to manage their enrollments, inbound and outbound communications and other stakeholder services. The application was used to distinguish enrollment cases, re-enrollment cases, safety event cases, service cases and fulfillment requests. Dynamic lightning forms would appear based on the unique combination of stakeholder, service type and indication. The application handled complex validation rules and managed task queues for agents. Automated follow-up tasks were created based on the logic defined in task schedules.

As per REMS requirements, Salesforce application tracked every single status change including the date of change and who made the change. The application was integrated to a data warehouse to track these changes for every single field. Enrollment summary data was accessible to the users through historical snapshots. Over 80+ outbound communications were configured to send out from the application automatically or manually upon user request. The application was integrated with third-party databases to validate NCPDP, NPI, SLN and DEA identifiers.

The Results

The contact center application built on Salesforce Health Cloud met REMS standards and 21 CFR Part 11 requirements.

Wilco Source successfully helped the client to manage REMS programs in the cloud. The data model designed for theXiaflex program met all Xiaflex requirements and allowed to scale the platform to other REMS and non-REMS programs.

The application helped providers and settings to undergo a smooth program enrollment process and helped the agents to send out program relevant communications in a timely manner.

Agents were delighted with lightning capabilities and realized how easy it was to perform their day-to-day operations in Salesforce compared to their previous application. Thus, by focusing on contact center application development, involving the application users early in the change process and by getting buy in from the leadership team through various design discussions and demos, Wilco Source contributed to successful change management.

The solution Wilco Source developed for the Xiaflex REMS program was a faster implementation than an implementation would have been in the previous REMS application. We delivered the project on time and on budget enabling the client to meet their customer’s deadline.