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How to Select an eClinical Technology Partner – The Ultimate Guide

Matching In-House Capabilities with Partner Abilities (Affordability, Scalability, Interoperability, Extensibility, and More)

Table of Contents

Introduction

Clinical trial sponsors and contract research organizations (CROs) have many options when it comes to choosing eClinical technology partners. The process of identifying potential collaborators and determining which will provide the most value can be long and complex. Yet making the best possible choices in this regard can have a significant impact on study success. This guide aims to help life science companies sort through this process by clearly outlining the kinds of capabilities and characteristics of a good partner.

What are eClinical Technologies?

The term eClinical in the clinical trials space refers to any solution that uses digital technology to collect, store, analyze, and manage research data. Common types of eClinical technologies include Electronic Data Capture (EDC) systems, Electronic Clinical Outcome Assessments (eCOA) and data collection via wearable devices, among many others.

Section 1: What to Look For – The Basics

Chapter 1: Scalability and Extensibility

Any technology, service or process employed during a clinical trial must be able to grow with the trial’s needs. This makes the ability to select, scale and extend eClinical services extremely important. 

An early phase study may be well-suited to a limited number of solutions, such as an EDC and relatively simple, on-site data collection. However, later phases may benefit from broader approaches, including those used in decentralized clinical trials. If this is the case, your technology partner needs to have the ability to add things like video visits, ePRO, or passive data collection from wearable devices. This level of flexibility is becoming increasingly necessary for modern studies, particularly as the industry strives to reach broader and more diverse populations of patients. To be successful, one-size-fits-all technology solutions are no longer sufficient.

Chapter 2: Ease of Use

Whatever vendor and solutions are chosen, it’s important to consider how easy the technology is to use for all stakeholders. The user experience for clinical trial site teams, in particular, must be as intuitive and unobtrusive as possible. Site teams, famously, have ingrained preferences for how they like to work. For a new piece of technology to be implemented, or if the sponsor seeks to change its EDC or other foundational technology, the solution must be easy to learn, easy to implement and easy to use on a daily basis. 

The participant experience also needs to be considered. With an increasing number of study designs calling for at least some DCT elements, all technologies that participants interact with need to be straightforward and accessible. 

Sponsors need the flexibility to configure and facilitate studies built with user experiences in mind. Choosing the right eClinical partners can help. Here are some questions to ask:

  • Does the eClinical partner offer a user-friendly, intuitive software solution to help our team easily customize our studies?
  • Is the eClinical partner able to provide Open API architecture to help ensure that technologies work well together?
  • Does the eClinical partner offer the training resources and support needed to help users stay on track?

Chapter 3: One Unified, End-to-End Platform

It is not uncommon for sponsors to use a variety of eClinical technologies and platforms for a single study. This can add unwanted complexity and labor burden for study teams. Modern clinical trials are complex, pulling data from numerous sources. Juggling multiple disparate and/or siloed systems is not realistic for most researchers. 

While vetting potential eClinical partners, sponsors should inquire about their capability to take in data and distill it into a single access point. The ability for study teams to access and analyze all study data from a single point helps to save time and costs while helping patient-facing team members to get back to engagement activities and other critical tasks. 

The best partner platforms will also provide the flexibility researchers need to employ any study design they wish and for any therapeutic area. With this ability, sponsors can more easily scale technology across multiple studies encompassing multiple indications.

Section 2: Building Complex Technologies That are Simple for Users

Chapter 4: Preserve the Power to Control Your Environment without the Need for Deep Coding Expertise

This eBook has discussed the importance of allowing life science companies to build, deploy, and manage their own studies versus entrusting these functions to a network of service providers. But how is this achieved? This and the following chapters will discuss the ways smart eClinical partners make this happen.

Easier Study Builds – What Does it Mean?

Study builds can be accelerated through the use of development platforms designed to simplify the user interface so that users can easily build applications and/or tailor existing applications to fulfill specific requirements, without the need for heavy coding experience. This entails making sure particular features are included or can ensure that the application works well given unique user workflows. Some of these simplified solutions do require the user(s) to perform some coding, though much less than with typical application development and often with useful built-in prompts and guides that make it clear what the users need to code and how. These platforms can be used by more tech-savvy end-users, but they primarily target application developers. This greatly speeds up the development process as designers don’t need to build everything from scratch. Rather they can pick and choose optional, pre-built functions, significantly reducing time, labor, and costs. According to a Gartner report, 65% of all application development by 2024 will be done using platforms that require minimal coding experience.

Going even further, there are solutions that allow users with zero coding expertise to still build highly effective studies. These are best fit for day-to-day, mostly non-technical users. As the name suggests, they remove all need for coding or programming skills, offering easy-to-use design tools that allow users to quickly build and use applications. Most people find themselves in the category of non-technical users with little or no coding experience, making these ultra-simplified solutions extremely attractive. This is particularly true for those seeking to deploy user-friendly applications with more simple and focused functionality that can be used across numerous device types, e.g., laptops, smartphones, and tablets.

Benefits to Sponsors of User-Friendly Design Platforms

Speed

Development platforms that make design simple for all users speed up aspects of study design, helping get trials up and running more quickly without the need for users to spend hours manipulating the code. 

For example, an effective solution provides sponsors with an intuitive, visual interface similar to other common software applications (think Microsoft, Google, Apple, etc.). This approach allows users to drag and drop in the components they need for their studies while avoiding those they do not. Such solutions will typically allow additional features to be added later if the need arises. For sponsors conducting numerous trials, the ability to quickly create customized user experiences based on a study’s particular needs (protocol design, eligibility criteria, regulatory requirements, etc.) can save a lot of time and money and help get safe, effective new therapies to market faster.

Software Training

By selecting only the components needed and activating them in an easy-to-use platform interface, sponsors can simplify onboarding. This, along with an intuitive and easy-to-learn user interface, allows team members to spend less time on training and more time focusing on higher value tasks like patient engagement. 

Enhanced Operational Processes

These types of development platforms make it easy to test components and features. Useful configurations and assets can be noted and saved to be repeated in subsequent studies. Features that don’t work as well can be removed easily and quickly. By building configurations that work well for them, sponsors don’t have to worry about investing in a platform package full of pricey features they seldom – or never – use. This makes it less risky to experiment with new features or functions that could lead to better study performance.

Keep User Options Flexible

It is important to choose a solution that allows for a user experience that is consistent on all devices (desktop, laptop, phone, tablet, etc.). Strong options should give the ability to develop fully featured solutions across all touchpoints. More user-friendly development platforms that allow users to build solutions with a mobile-first approach in mind can help ensure that all features and functions work well across all devices. For example, by making functionality like notifications and visual dashboards native to the mobile experience, the development platform can allow the study team to more easily work backwards to ensure these same features are optimized on a computer workstation as well. 

Leaving Room to Grow

Intuitive, easy-to-use development platforms allow sponsors to more easily scale features in their study. Both the ability of study leaders to add and subtract features and the ability to quickly implement new features are made realistic through the intuitive user interfaces common in these platforms. This helps to preserve the sponsor’s control over what features are being used.

Chapter 5: Preserve the Power to Control Your Environment – Open API Architecture

Interoperability remains the modern technology challenge that will not go away. This is true for all industries, but is particularly acute in clinical research with its unique set of data security and privacy requirements designed to protect patients’ information and their health. New technologies are being developed and implemented all the time, each meant to improve efficiency in one or more specific ways, yet there is not (and likely will never be) a singular technological solution that can do everything researchers need to conduct complex clinical trials. Thus, numerous approaches have been sought and created to help all of these disparate technologies to work better together. The results, of course, have been mixed and a panacea has yet to present itself.

One Fundamental Truth

Life science companies must keep in mind one bottom-line truth; their data is just that – their data. Simply stated, any organization running a clinical trial should be able to access its data, including raw data, whenever and however is needed. Data should be easily movable. Finally, life science companies should never be asked by a vendor to pay extra in order to access or move their own data.

One proven method for delivering this level of data flexibility is a cloud-based Open API architecture. API stands for Application Programming Interface and is a software intermediary that allows different software applications to talk to each other. An important type of API is referred to as REST (representational state transfer technology). RESTful APIs use Hypertext Transfer Protocol (HTTP) requests to create, read, update and delete data. RESTful APIs are used frequently and widely due to their relative ease of use and their ability to work well across different types of data. Open API is an example of a RESTful API. 

What does all this mean? It means data can be exchanged securely, quickly and easily even between very different types of technology platforms. For example, Open API can be very useful in securely and accurately moving data from an Electronic Health Record (EHR) platform to a research-specific EDC platform. EHRs are a treasure trove of data. Data from EHRs can be useful in helping study teams better understand population health which can help guide more precise recruitment efforts and provide insights that lead to more effective study designs. It can also be mined to build highly detailed and in-depth patient registries. The lack of technological interoperability between common EHR platforms and the many different electronic data capture (EDC) solutions is largely to blame for keeping researchers from accessing and taking advantage of the volumes of raw, unstructured data found in EHRs. 

How is EHR Data Different?

EHRs are patient medical records in digital format. These systems are built to collect and store data about patients to aid in their clinical care, moving with them should they change doctors, see a specialist, or need to visit the emergency room. EHR systems facilitate sharing of information among care providers; they were not built with clinical research in mind. This means that data from EHRs, from a research perspective, is unstructured. It is then difficult to access and analyze this data without the right tools.

Causes of Interoperability Challenges for Clinical Researchers

  • Many EHR Systems to Choose From – There are many different options for EHR systems and very little agreement between healthcare providers. Even within communities, there can be multiple healthcare provider networks with different records platforms, not to mention various physician practices. The features and functionality found in the various EHR systems, while largely similar, possess enough differences to create variances between what the data looks like from one EHR system to another. 
  • The Human Factor – Initial entry of patient records into the EHR system is still performed by humans. While EHR software largely does its best to guide users through data entry in order to prevent errors and encourage consistency, there is still room for variations in how data is entered from one clinical site versus another.  
  • Lack of the Right Software Architecture – Some clinical trial EDCs struggle to play nice with EHR systems. Again, this makes sense as the two types of software platforms were initially built to do very different things. Just as there are multiple EHR platforms that healthcare providers can choose from, there are many EDC options for researchers. Further variation occurs when multiple sponsors and/or contract research organizations are involved. So even if one party brings an effective EDC, a partner with a less effective solution can muddy the waters and slow things down.

In addition to facilitating important data transfers such as those from EHRs to EDCs, Open APIs also mean easier access to data and less data entry burden for researchers while maintaining compliance. As an example, Open API allows users to link an EDC platform directly to the clinical trial management system (CTMS) so that members of the team no longer have to input data into each system separately; the Open API can import this data automatically. This helps an Open API to maintain 21 CFR Part 11 compliance via edit checks in the EDC system. As an example, a user tags a piece of data as being monitored within the EDC system, which triggers the Open API to make a similar notation in the CTMS.

The Benefits of Direct, Secure Access to Your Data

Open API architectures provide real freedom to users. Via the Open API, users can effectively analyze and move data from any EHR format or other eSource into a clinical trial database as clean, structured data. Researchers today are using Open APIs to help integrate all manner of data platforms ranging from central labs to CTMS and beyond. With the growing use of DCT approaches that include remote data collection from smartphone apps, wearable devices and other methods, the ability for Open API to securely and accurately facilitate the exchange of huge amounts of patient data is extremely useful. This ability also opens things up for researchers, allowing them to dramatically expand the types of data they collect and even include additional endpoints. The freedom afforded to research teams by Open API means fewer limits to how they design studies and collect and manage data. Easier access and more control of trial data can only result in more efficient studies that help make new therapies available to patients faster. 

Chapter 6: The Support Life Science Companies Need

When sponsors and CROs choose to work with an eClinical technology partner, it represents both an important investment and relationship. It is vital to make sure that the partner holds the same commitment to collaboration and success. One way to ascertain a potential partner’s level of dedication in this regard is to look into their approach to customer support. While many companies talk about support as if it is table-stakes, do they really put their money where their mouths are? 

Ideally, a good eClinical technology partner will provide support 24 hours per day, seven days per week, every day throughout the year. Further, they should support where the sponsor is located, preferably with multiple language options. This means they can be immediately helpful and problems do not need to persist for hours (or in some cases days) before help is offered. 

Chapter 7: Affordability

While there are myriad options for eClinical vendors, there are just as many cost models for the use of these technologies and services. It is important for sponsors to begin thinking about exactly what they want the partner to provide when considering budgets and contract discussions. It is helpful to view this critical investment in terms of total cost of partnership. 

Although it makes sense to try and fit the eClinical vendor contract to the precise needs dictated by the study protocol via traditional fee-for-service models, this type of service picking has the potential to add costs quickly. This is particularly true if change orders are necessary over the course of a study. While researchers may have a good idea what they need their eClinical partner to help with, there are several cost buckets that need to be understood, such as:

  • Infrastructure tweaks necessary for the software to run effectively
  • Training
  • Implementation and start-up 
  • Data hosting
  • Personnel hours to build and maintain studies 
  • Archiving of data

One way to avoid the kind of cost-creep common with traditional fee-for-service is to explore potential collaborators who offer subscription-based services. Subscription services may, at first glance, appear to cost more than a fee-for-service contract, but are often much more cost-effective by eliminating opportunities for change orders and cost-creep. Further, the right partner will provide intuitive solutions that don’t require researchers to have deep coding experience, allowing for services to be launched and sustained more simply. 

Adopting an enterprise model is another approach that allows for more predictable budgeting and flexibility. Partners who offer enterprise-level access enable their users to leverage the entire platform across all their studies, This allows for the standardization of one unified solution, as discussed in Chapter 3. Sponsors and CROs can also realize higher savings at the enterprise level with significant volume discounts, thus lowering the overall cost to conduct clinical trials.

Conclusion

There are many factors that go into choosing the best possible eClinical technology partner. Continuous advances in technology, though meant to make clinical trials run more efficiently and effectively, can also add complexity due to issues with interoperability and overly complicated user experiences. Technology partners can help sponsors preserve their control over their studies, ultimately allowing sponsors to be as self-sufficient as possible. With this guide, the hope is that sponsors can more easily identify partner traits to look for as they determine what is needed for their specific studies. 

For more information, visit www.crucialdatasolutions.com