Clinical Trial Management with Salesforce

Solving the Use Case

Overview

With the right configuration, Salesforce Health Cloud can be configured to handle every aspect of clinical trial management. Whether it's finding ideal participants from defined populations, onboarding patients, or managing support cases, Salesforce has clinical teams covered.

Solving this use case begins with defining users by setting personas, permissions, and roles in Health Cloud. These roles are created to fulfill the requirements of clinical teams across multiple trial sites. These include:

• Clinicians
• Data Scientists
• Compliance Managers
• Communications Specialists
• Clinical Administrators

Clinical Trial Data Model

Each life sciences company has unique challenges when managing a clinical trial. As a result, the object model will vary from platform to platform. In the most basic implementation, we create a data structure to represent the relationships between clinical trials, trial locations, health conditions, and patients. The simplest object model we configure includes:

• Clinical Trial Object
  Stores and displays high level details about each clinical trial. Fields include trial sponsor, number of sites, total spend, trial phase, protocol ID, National Clinical Trial Number (NCT ID), and the clinicaltrials.gov URL.
• Clinical Trial Site Object
  Stores and displays details about each trial site. Each trial site can roll up to multiple clinical trial objects. Fields include site staff, location details, site address, and country.
• Master Health Conditions Object
  Stores and displays the health conditions present in each trial. This object is primarily used to track multiple health conditions across each trial and manage health conditions by site.
• Patient Object
  Stores and displays data related to each individual patient. This could include demographics, eligibility details, top-level goals, milestones, outcomes, clinical data, or information collected during registration.

Streamlined Clinical Processes

We streamline processes across a lightning flow for each object model. Usually, we configure the Clinical Trial flow first. The flows will differ based on whether they represent pre-clinical, post-clinical, or active trials. Here's an example of the active clinical trial flow:

• Recruiting
• Enrolling
• Suspended
• Terminated
• Withdrawn
• Completed

Collaboration

Collaboration across clinical staff, business analysis, communications, compliance, and intake teams is incredibly important to running an efficient trial. Salesforce Health Cloud has some out-of-the-box components that can streamline the way teams work together. Chatter ensures that individuals can easily communicate on each object, including trials, sites, and patients. This allows interactions to be highly visible amongst key stakeholders.

Additional configurations with Slack and email ensure that more targeted messages are available.

Patient Experience

An external portal built in Salesforce Experience Cloud allows patients to search for clinical trials by condition, location, and other criteria. The Experience Cloud site displays data from Health Cloud in real-time, giving patients up-to-date information about clinical trials that may interest them. Each individual trial has on-demand, pre-screening, and registration forms which quicken patient enrollment, and reduces the amount of patients who are rejected on site.

Additional workflows provide consistent experiences at every phase, keeping them engaged and reducing patient leakage over the course of the trial.

Security

We configure a variety of platform, application, network, and infrastructure controls for security and compliance.

Platform
Salesforce Shield provides platform encryption, event monitoring, and field audit trails

Application Services
Single Sign On, Two-factor authentication, user roles and permissions, and field security

Network Services
Encryption, threat detection, firewalls, and IP restrictions

Infrastructure Services
Backup, disaster recovery, third-party certifications, and audits