Clinical studies are a critical component of Life Sciences organizations, with millions of dollars being invested each year to gain insight into disease, treatment options, and patient outcomes. These studies are executed at various sites across the world and involve a variety of systems and services that need to be provisioned to a large number of users (internal and external) who need access to these systems and services. One of the major challenges of conducting a large-scale clinical study is the management of access to these systems and services that carry sensitive patient data.
User provisioning is a crucial process for many organizations that involves the identification of clinical data access needs for different users based on their roles, reviewing and approving those needs, and providing necessary access privileges. This process also includes de-provisioning those privileges when they are no longer needed, all while maintaining the highest standards of data integrity, privacy protection, and audit trail.
Traditionally, user provisioning has been a manual and time-consuming process. Users must be individually vetted and then granted access to the appropriate data sets – a process that can take weeks or even months. Often, companies use rudimentary tools like emails, Excel sheets, Word docs, SharePoint, and more, for executing and tracking clinical data access requests. This manual process not only slows down the pace of the clinical study but also lacks the needed visibility into the overall status of user provisioning. This can increase the risk of errors, such as granting access to the wrong data set or to an unauthorized user.
Modernizing the User Provisioning Process
If your clinical user access management process has any of the above challenges, it is possible to modernize this process using a Low-code Process Automation technology platform, while still leveraging your investments into your existing systems that support this process.
I am going to share my thoughts on how we have leveraged a market-leading Low-code Process Automation platform to streamline access to clinical study data for some of our large pharmaceutical customers. But first, let me explain what Low-code Process Automation is.
Low-code process automation is an approach that enables businesses to create applications and automate business processes that integrate in real-time with your current and legacy systems with minimal coding effort. This approach typically involves the use of drag-and-drop interfaces and pre-built components to quickly create applications that can automate processes and workflows, bring data from various systems together, automate decision-making via configurable rules, provide deep insight into processes via interactive dashboards and deliver a modern, mobile-enabled user experience in a short period of time.
The first step in modernizing user provisioning is to define the user roles and permissions required for accessing clinical study data. These roles and permissions can be defined (in the Business Rules) and often include Principal Investigator, Clinical Research Coordinator, Clinical Research Associate, Medical Monitor, Pharmacist, and more. Once the roles and permissions are defined, they can be used to create a set of rules that determine what type of study data each role is allowed to access.
If training is required as a prerequisite this can also be automated by integrations directly with the organization’s Learning Management System (LMS) to ensure that those requesting access to study data have successfully completed the required training.
Next, a custom workflow application is created that automates the process of reviewing, approving, and granting access to clinical study data based on these roles and permissions. This custom workflow application can be designed to automatically grant access to the appropriate data sets based on the user’s role, eliminating the need for manual vetting and approval.
To ensure that only authorized users can access clinical study data, the custom application can also include authentication and authorization mechanisms, such as single sign-on (SSO) or multi-factor authentication (MFA). These mechanisms ensure that only authenticated and authorized users can access the data, reducing the risk of data breaches and protecting patient privacy.
The custom application can also be seamlessly integrated with access provisioning systems to provide a unified end-to-end view of the business process. For example, for a client, we built the access rules and permissions along with the workflow to automate the approval in Appian, with real-time integration into ServiceNow for the actual provisioning. The most updated status from ServiceNow is always available on the Appian Dashboard, providing real-time insight into the overall progress.
Benefits of modernizing user provisioning with Low-code Process Automation
With the Low-code approach to modernize user provisioning for clinical study data access, sponsor organizations can see process benefits in the following ways:
- Process Transparency: Low-code Process Automation creates transparency across the entire business process by integrating with your existing systems and your teams that review and approve these access requests, so you can see overall process metrics and drill down to the status of each request. This also helps identify bottlenecks in the process.
- Reduced risk of errors: Automating the user provisioning process eliminates the risk of errors associated with manual vetting, duplicate data entry, and email approvals, such as granting access to the wrong data set or to an unauthorized user. This also reduces the risk of data breaches and helps maintain data integrity.
- Enhanced security: By including authentication and authorization mechanisms in the workflow application, modernizing user provisioning with low-code process automation can also enhance security. SSO and MFA mechanisms help to ensure that only authorized users can access clinical study data, reducing the risk of data breaches and protecting patient privacy.
- Improved compliance: Clinical studies are subject to strict regulations and compliance requirements, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States. By automating the user provisioning process and including authentication and authorization mechanisms, modernizing user provisioning with low-code process automation can help organizations comply with these regulations and provide complete transparency to compliance auditors if required.
- Rich User Experience: Low-code apps are natively mobile responsive and provide a modern user experience. This results in improved efficiency and increased data accuracy.
- Flexibility and scalability: Low-code process automation platforms are designed to be flexible and scalable, allowing organizations to easily modify the workflow application as business needs keep changing.
- Increased efficiency and improved cycle time: Automating the user provisioning process reduces the time and effort required to grant access to clinical study data, allowing users to access the data more quickly and efficiently. This increased efficiency can lead to faster clinical outcomes and help manage the clinical trial budget more cost-effectively. Since the time spent on each step to provision user(s) is greatly reduced, it reduces the overall process cycle time.
Modernizing user provisioning for clinical study data with Low-code Process Automation offers numerous benefits for pharmaceutical and biotech companies. These include a user-friendly and modern user experience, workflow automation, and real-time integration with existing systems to gain full visibility into the process and drive informed decision-making.
By automating the user provisioning process, organizations can increase efficiency, reduce the risk of errors, enhance security, improve compliance, and enjoy greater flexibility and scalability leading to faster clinical outcomes and the ability to stretch the clinical budget further.
As more sponsor organizations embrace Low-code Process Automation to streamline and modernize access to study data, we can expect to see even more innovations in clinical research in the years to come.