February 2022 | Vincent Puglia

Clinical trial technology is typically a constellation of systems and devices that exists in a continuum with the subject at its center and cocentric rings extending out to sites, partners, providers, CROs, and sponsors. A good clinical trial system (sometimes called “eClinical system”) will enhance efficiency and speed during the clinical trial process, all while keeping subject safety and trial data integrity at the forefront. A system provider and its services should also harmonize with each layer or collective’s current situation and future goals. In this blog series, Vincent Puglia identifies the key factors of vendor fitness and discusses how problems are most likely to occur when there are too many underlying variables.

It is our pleasure at McCreadie Group to welcome Vincent as a guest blogger. In Part 1, Vincent provides those charged with the responsibility to procure and guide the implementation of eClinical technologies and systems with a strategy to reflect on their own needs, requirements, and current workflows. These considerations will inform the evaluation of prospective or current providers, with an eye towards maintaining and cultivating relationships predicated on operational excellence. In his follow-up blog,Vincent will provide guidance on how to evaluate systems and providers to ensure they’re a good fit.

Vincent Puglia, Director of Clinical Supply Systems at Regeneron, is an eClinical software, service, and digital transformation executive leveraging experience across provider and sponsor organizations building teams and collaborating on integration, IRT, eSource, DCT, eclinical technology, and logistics while focusing on blending  business & technology to deliver a singular, inclusive experience.

The Clinical Research Systems Landscape

Systems and solutions in the clinical trial space have a special responsibility to operate in a strictly regulated domain to protect patients, reflecting not only the direct impact they have to the care provided, but also to the strategic and tactical decision-making around the trial.

Given this critical task of building and maintaining relationships that drive success, I am proposing you begin this process with a series of reflections to clearly define expectations and create a reasonably maintainable environment that spurs performance.

Pendulum, On the Double

Traditionally, one of the most difficult problems to solve in history has been the so-called “double pendulum” problem – trying to predict the path of two interdependent pendulums. With a single pendulum, such as on a clock, you can do some direct calculations and accurately predict each point on its path. However, if you hang another pendulum on the end of the first, it becomes exponentially more difficult to predict the path of both.

What does this have to do with you and your provider? Well, if one of you doesn’t have a clear idea of your true needs, expectations, and how to get there, then you’re both in for a complicated journey. If either of you wants to solidify your position, you as the customer should be the one to define and establish it. Even Newton couldn’t find a satisfactory answer to the double pendulum, so it’s best to avoid it!

The Right Approach? First, Know Thyself!

There is no shame in taking the time to do an honest assessment of your company’s situation and needs. You need to know your strengths and deficiencies and set reasonable expectations. The main elements of that appraisal will describe your attitude toward the type of engagement you need from a provider, your standard way of doing things, and how the vendor can support, complement, or even inspire change in your work process.

In finding the right service provider to make the entire process a success, you must first understand your business expectations and needs by answering the following questions.

What type of experience are you looking for? Clinical trial technology or service?

Are you mostly focused on the technology and tools, or do you need all the expertise and background to go with it? Do you have the internal capabilities required for running trials and need extra capacity, or do you need support in designing and overseeing the complete project? If you know exactly what you want to do with the technology and just need a best-in-class solution with workflows that meet your needs, that requires a completely different approach compared to a scenario of technology plus access to experts to help you solve tactical elements. It’s okay to say that you don’t have enough resources and that you need support. In your organization, there may be a mix of “just give me the tool” and “I need my … tech person,” so sorting out those personas and making sure they are represented in your research is critical.

Does your company have a standard and well-defined way of working?

This can be anything from Standard Operating Procedures (SOPs) to setting business requirements for the minimum viable standards of your workflow. Each part of the trial should have its own set of SOPs which should be developed by the trial sponsor (with or without support from the clinical trial partners). This is an important aspect of quality control. SOPs are detailed written instructions used to ensure consistency in clinical trial management. They provide a general framework for effective implementation and execution of all trial-related functions and activities.

This doesn’t necessarily mean granular or ultra-specific technical or other requirements. In general, it’s better to focus on the desired outcomes, or in other words, focus on the “what” you need rather than the “how.” Some of the most effective requirements or guidance I have seen are pretty straightforward, including spreadsheets with lists of minimum expectations/needs to highly contextual collections of behaviors and outcomes (e.g., matching user stories with narratives like “As a …, I want a … so that …”).

It makes sense to establish a solid set of expectations to which the provider can align and level-set with before the clinical trial project begins. The advantage of having well-articulated and defined requirements is that they help the provider add a high level of value that goes well beyond the minimum expectations. They will also help you avoid the problematic gray area of attempting to define the outcome while both monitoring and ensuring the completion of high-quality projects. The worst-case scenario is being in the “wilderness” with a hazy set of objectives, overlapping deliveries that put a burden on resources, an ever-growing risk register and backlog, and no clear sense of when you’ll achieve stability. Managing the vendor or service area becomes an excessive drain on resources you can’t (or shouldn’t) offer. After all, the primary reason you’re seeking vendors and solutions is to develop and increase your company’s capabilities!

What are the tools and indicators of readiness for adopting a new clinical trial system?

Mapping of SOPs

Provider- and/or solution-agnostic minimum business requirements: The “what” that will be in systems and workflow, instead of the “how.”

Budget and Resources: Besides the expected line-items for a solution, consider the following questions:

1. 1. Do I have the budget for qualifying a provider? This is about more than just the cost of the service. It’s also about the time, resources, and budget for the stakeholders in your organization who need to perform the assessment and qualification (e.g., IT/safety assessments, audits, procurement, background checks). There’s nothing worse than initiatives gaining momentum and then stalling or being delayed for a year because a key business partner in your organization didn’t know that a vendor was due to be assessed or engaged in the coming time period and doesn’t have the necessary budget and human resources to make it happen. Sadly, it happens more often than you would think!
   2. Do I have the budget for onboarding and ongoing maintenance of the solution and business relationship? This is especially true if you’re maintaining a “template” or solution that represents standards and need to perform cyclical user acceptance testing or validation.

Other Business Systems: You will also want to consider how this provider and solution will fit into relevant ecosystems.

1. 1. Are there other solution integrations that are critical now or might be explored?
   2. If so, how do they relate to my business systems? For example, are they able to work well with your finance, accounts payable, and/or contracting functions?

Answers to the above questions will help you think about whether you, your team, and your organization are ready to work with the planned clinical trial service providers. Of course, being ready is only half the battle, because you also need to find the right provider for the job. In the second part of my article series published in the WHEN, I will share thoughts on qualifying clinical trial providers and, once you have found the right partner, overseeing the collaboration.