How to Approach Systems Integration and Single Sign-on in Your Clinical Operations

Posted by Kris Connolly on Sep 30, 2019 10:23:38 AM

This is an excerpt from Longboat's ebook "A Guide to System Integrations and Single Sign-On for Clinical Operations Teams”. To download the full ebook, click here.

One of the first considerations when thinking about integrating your clinical trial systems is to think about what you want to achieve. Are you integrating a few core existing legacy systems to make running all of your future studies easier? Or do you want to integrate certain platforms for a specific study with particular data requirements?

We would argue that in today’s clinical trials, integration is an essential rather than a nice-to-have. However, there are different levels of integration and ways to introduce SSO that can be implemented, depending on your organization’s need.

 

What systems are in scope?

Once you’ve agreed on the objective of your systems integration, the next step is to consider all the systems and services used across your trial, and decide which ones are in scope for integration. These might include different systems used for:

  • Participant randomization
  • Determining drug and dosage
  • Managing drug supply
  • EDC (including patient-reported outcome instruments or other devices that measure clinical data)
  • Trial management – including systems that support risk-based monitoring 

Some of these systems are highly specialized and clinical operations teams cannot be expected to know all the finer details of how the technology behind the platform works or how different systems ‘talk’ to each other. That’s why it is essential to work closely with platform providers and their technical experts to get the next stage - requirements gathering – just right.

 

Requirements gathering

Having agreed which systems are in scope, the next stage is to work through the finer detail of their various’ functionalities and consider how they will talk to each other. This requires both an understanding of the business function of the data as well as the system that manages it, and so requires close collaboration between both clinical operations and technical teams.For example, it’s important to understand the ‘rules’ associated with data management in each system, and the importance of this to the clinical study (e.g., timing of data capture or transfer).

This means that once the systems are integrated, clinical operations teams can be assured that the same standards that apply to the data in its original home are replicated within other systems. Decisions will also need to be made about how data is transferred – that is, whether data feeds are push or pull, and whether data is transferred in real-time or in batches.

Factors such as different formatting of data (think site or patient ID numbers) between systems can also become an issue later if they are not agreed upfront.

 

Who needs access?

The next stage is to define the discrete user groups for each system and the levels of access they will need. Once you have this information, you can choose the best SSO strategy to meet your needs. What do we mean by that? Well, the type of SSO you choose will likely depend on the level of security you need and how your data is stored.

There are also a number of industry standards emerging - such as Security Assertion Markup Language (SAML) and OAuth – which are making it easier to implement SSO for different types of platforms.  

That said, for the non-expert, knowing how to implement SSO can be a minefield. Thankfully, there are some simple ways to introduce SSO, which vendors like Longboat can offer guidance on, to meet the unique needs of your organization.

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Conclusions

Systems integration and SSO can transform your clinical operations by facilitating easy yet secure and fast access to trial information and data. As trials continue to become larger and more complex, integrating multiple, disparate systems is becoming a necessity. At the same time, new eClinical tools promise to accelerate many aspects of clinical trials, but if they cannot be used together, this promise will not be realized.

A systems integration and SSO strategy can make the addition of new platforms straightforward and remove the need for additional security measures and authentication procedures. In turn, this helps to improve the day-to-day running of your trial by enhancing the experience of everyone using your trial’s systems: sites, study managers, and patients alike.

When considering your approach to systems integration, it’s important to realize that it doesn’t always have to be led by one organization.

In fact, bringing together the expertise of technology providers and clinical operations teams from the outset is most likely to pave the way for smooth integration. Software providers are increasingly open about API-sharing, recognizing it as an important means of running a number of services seamlessly together, and from a number of different environments.

At Longboat, we have the expertise and technology to bring together different systems seamlessly – but we are equally keen to ensure that our systems integrate well with others. We believe it’s most important to the overall objective of clinical research that software providers are flexible about plugging in to whatever centralized system best meets the operational needs of the study in question.

Technology has the potential to revolutionize clinical research. But only with integration can these innovative tools developed to simplify and smooth clinical trial processes deliver their true potential.

This is an excerpt from Longboat's ebook "A Guide to System Integrations and Single Sign-On for Clinical Operations Teams”. To download the full ebook, click here.

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Topics: Single Sign-On, Clinical Operations, Clinical Operations Teams, Systems Integrations