By: Lisa Gadberry
eClinical technologies have become pervasive across clinical trials, whether the study is more traditional or implements decentralized elements. However, even top-of-the-line systems — ePRO, eCOA, EDC, or any other — do not inherently make clinical trial operations more efficient or less burdensome on patients and site personnel. A significant amount of the value offered by eClinical technology derives from the technology provider’s accompanying support services.
While a sponsor and CRO can hand project specifications to a tech provider and walk away, outcomes are likely to suffer in the absence of ongoing collaboration and active provider support. A tech provider brings its clients not only the tools to run a clinical trial, but a wealth of experience gained from past projects, while the client provides expertise in its product, research objectives, and protocols. Through the tech provider, support often emerges as a salient differentiator between vendors.
Regardless of the technology or provider utilized, taking advantage of support services helps sponsors and CROs ensure system implementations that align with client objectives and generate accurate study data that is reliably accessible when needed. Clients who overlook the importance of support services, or do not receive adequate support from their technology provider, miss out on a more complete understanding of their eClinical products, the scope of their capability, and the value they can generate via positive client and user experiences.
How Support Services Create Value
Tech provider support from EDC study deployment to system training typically is considered standard. However, there is great variety in the actual value provided by this support, much of which depends on the client. Are they a “full-service” client, commissioning the vendor to provide all trial design work, an “enterprise transfer” client, wherein tech provider trainers guide the client in designing their own studies, or somewhere in between?
Some sponsors and CROs have the resources to manage everything in-house and just contact their tech provider if they have questions or need additional training. Other clients have insufficient in-house expertise or simply prefer to allocate their resources elsewhere. Knowledge of a client’s internal capability creates a jumping-off point for the tech provider, because it informs discussions/decisions about which technologies and support services the client will need throughout the duration of the project. For example, a client that has completed several studies on a platform requires markedly different service levels than a client new to that platform.
Trial design services are at their most effective when supported by an experienced training team and a trial designer, whose input is crucial to understanding and accommodating client needs. The training team and trial designer carry out these exercises often and support studies across a number of therapeutic areas and phases, empowering them to provide both expertise and historical context (i.e., what has worked and what has not) to the client.
Moreover, when a study goes into production, it is rare that protocol amendments do not occur, reengaging trial designers to implement changes. Experienced trial designers know such changes will occur and are prepared to execute them. So, initial study design should be clean and functional. But, if (when) changes become necessary, it benefits the client to have access to project management support services from a tech provider that knows what such changes may entail and how they will be carried out, and is able to minimize disruptions caused by the protocol amendment.
When user support is required, the criticality of an accomplished tech provider help desk is thrust into prominence. Accordingly, it is important to note where and how a provider’s help desk is operated. Specifically, is it staffed directly by your tech vendor’s employees, who are well-trained and experienced in that vendor’s products and processes, or are the phones manned by contracted personnel who are serving the same general function for a number of similarly styled organizations?
Solution consulting (i.e., advising clients on technologies and feature choices that add value, versus just trying to sell them everything available) should be interwoven throughout a comprehensive customer support program, from engagement through initial deployment, during protocol amendments and day-to-day study management. A well-informed client will make implementation decisions with greater acuity, resulting in significantly greater realized value to the organization from their use of technology. However, the general goal should be to right-size the contract and options for each client based on their needs, rather than view these regular interactions as “upsell” opportunities. In fact, sometimes the right choice is to forgo a feature that may previously have been viewed as necessary.
Ultimately, education is the lynchpin of constructive support services. Thinking within the context of the key deliverable, the tech provider should give clients information and ask pertinent questions conducive to well-informed decision-making. These conversations might include discussion about the benefits and drawbacks of a given product feature and where it can add value to the project. Will that feature directly contribute to more effective data entry and cleaner data review?
For example, form creation scripts are not a regulatory requirement, but their use can add value through improved data entry, reduced data cleaning, and better overall regulatory compliance. Consider that investigators do not want a pregnancy form to populate within a case book if the patient is male or otherwise not of childbearing potential. The tech provider can install triggers, based on patient responses to other forms, to prevent patients from receiving inappropriate/nonapplicable forms, rather than clutter the user’s view with unnecessary forms and questions that result in additional downstream data cleaning and drive unnecessary labor costs.
Still, since many eClinical product features and service suggestions come from customers in similar situations, it makes sense that project support teams bring up newly available tools and services to clients. In doing so, those project support teams allow each client to benefit from the collective learnings of previous clients. These discussions also can take place after initial deployments occur — a due diligence exercise that keeps clients informed of system updates in case the client wants to consider the benefits of a new feature to an existing study.
Tech provider support services are most useful when they are adaptable and responsive, moment to moment, providing value based on a client’s current need — versus being the cheapest or offering the most bells and whistles, many of which may not be unnecessary. Maintaining this flexibility requires a vested interest in the present and a focus on the current project, rather than an eye toward the sponsor’s next study.
Accordingly, seek a provider that asks instead, “How are things going? What has your experience been like? Are there things you feel we could do differently?” That feedback informs product and process improvements conducive to optimized user experiences end-to-end during a study. That shared investment and vendor-client collaboration — not a sales pitch — should help determine whether the partnership continues into subsequent studies or is expanded.
Am I Getting the Value I am Due?
For clients, the determination of where value can be added to an eClinical system begins with an assessment of their current system and service performance, needs they have identified, and areas they would like to improve. What does a positive user experience, including reliable data entry/accessibility for the right people, look like to you?
Questions a client might ask during assessment of its eClinical system include:
Clearly, eClinical product evaluation should extend to support services, as well, to gain the most value from a solution. Initial studies generally require more “handholding” by the tech provider, but clients become more adept with each study and need less support. The provider should work with its clients to reevaluate their needs from study to study, apply lessons learned, and gain an understanding of the client’s standard of use so that efficiencies can be gained on both sides. Demonstrations and trainings are precious in this respect, because end users who are not as familiar with the technology can see granular details that help them understand the functionality of a product or feature, as well as how it can be supported, allowing them to envision how the product/services may benefit end users.
Finally, it must be acknowledged that changes are almost always required in a EDC study. Understanding how protocol amendments and other services executed by the tech provider are handled — before the change is required — can provide great value to clients, who want ensure the process is seamless for end users and is not disruptive. When making such changes, some systems require data be removed and copied (migrated) while implementing new or improved features, then re-added when the updated system is reactivated for use. Studies can ill afford timeline setbacks — or worse, loss of patients if data is compromised during the process — because the EDC database is being migrated for a change order. The goal is to achieve an understanding of the trial and the technology as close to accurate as possible, to accept protocol amendments are likely at some point, and to be prepared and equipped to respond to such changes.
Designing a clinical trial, including identifying eClinical technologies and support services that may help or hinder the study, is an increasingly complex endeavor. End-to-end collaboration contributes to the efficacy of product education and drives mutual understanding of study processes. It ensures the client understands what they need versus what might be nice to have: a very robust EDC system, or a spartan platform. Just because a provider can offer a client the sun and stars does not mean it should – that may not be what the client requires. A more appropriate approach informs the client of their options, provides necessary context focusing on what may or may not work, and provides bespoke suggestions based on each client’s particular circumstances.
To learn more, contact the author or visit us at www.datatrak.com/services/professional-services.
About The Author
Lisa Gadberry currently serves as the Director of Operations at Datatrak. In this role, she oversees operational areas, directly managing Project Management and the Datatrak Solution Center, which services the platform’s front-end users. The Operations department focuses on direct support to Datatrak’s clients and partners and as such, Lisa’s primary goal and responsibility is ensuring a successful client experience in regards both to system integration processes and day-to-day usage. With over 15 years’ tenure at Datatrak, she has held a number of positions within the Datarak Clinical and Consulting Services group and has a wealth of experience in eClinical technology. Lisa earned her Bachelor of Science in Business Administration/Finance as well as a Master of Business Administration from The University of Akron.