Contents:
- Using an EDC in Early Phases to Boost Study Efficiency
- Choosing an EDC to Support Every Study Phase
- The Right Solution Means a Quick Build Time
- Feature-Rich Platforms Enable Seamless Study Management
- Unified Platforms Grow with You
- Enabling Flexibility Throughout Clinical Trial Phases
- One Solution
Introduction
For clinical trial sponsors, assessing options in the global eClinical solutions market can be an overwhelming task. Emerging technologies, evolving standards, and increasingly complex clinical trial designs all impact a chaotic marketplace. Traditionally, research organizations use eClinical tools geared toward specific clinical phases. That is, point solutions offering limited automation of specific tasks would be used for early stage trials, while complex suites were employed for large, later stage trials. Some sponsors even continued to conduct inefficient paper trials in the absence of available and scalable solutions that offered core capabilities. This approach treats the clinical development lifecycle and the clinical team as standalone entities. In some instances, this practice may be appropriate as it relates to the use of some specific eClinical solutions – such as Clinical Trial Management Systems (CTMS) or specific mHealth capabilities – required for specific later stage and / or more complex study requirements. However, many organizations also apply this approach to the selection of Electronic Data Capture (EDC) or Clinical Data Management Solutions (CDMS) in early stage trials, considering these types of solutions as a disposable, short-term tools with no recurring return on investment. Clinical teams were left to learn and relearn various technologies and had little opportunity to expand use of the tools or get more from their investment.
Today, unified and flexible Clinical Data Management Solutions (CDMS), centered around a robust EDC built with core native applications that also allow for key integrations can deliver value across all types and phases of clinical trials. These solutions are supporting clinical trial design and execution as a comprehensive and flexible process rather than discrete tasks that require automation. The industry continues to seek automating and enabling options that address the challenges of conducting and managing clinical trials. According to Grand View Research, the global eClinical solutions market size is expected to reach $13.73 billion by 2026.¹
Using an EDC-Centric CDMS in Early Phases to Boost Study Efficiency
Historically, early phase trials used paper – it was faster to deploy, required limited training and was perceived to be low cost. However, the perception of low cost is not always the case, as paper based studies can ultimately cost more in labor costs, depending on the study design. In addition, advancements in EDC and CDMS technologies are making it easier and faster to build and deploy studies, while easy-to-use interfaces coupled with an increasing number of people familiar with the CDMS reduce the time needed for training.
Using an EDC that is part of a comprehensive CDMS solution in the early phases can offer significant value throughout the entire development and clinical trials process. Dynamic controls and alerts improve data quality and realtime data access optimizes decision making and patient safety. At the same time, it provides users with consistency, reducing the time needed to move to the next phase of research.
Employing an EDC-centric CDMS early also enables cross-functional teams to develop experience with a solution at a manageable scale. If there are trial design, process or training issues, they can be addressed prior to launching a large, late phase trial. This organizational knowledge also helps teams from different departments (or different development teams) to communicate more efficiently. If everyone is using the same tools and terminology, communications are more accurate and efficient and the entire process benefits. The optimized process using an appropriate technology becomes an organizational asset.
Choosing a Technology Solution to Support Every Study Phase
Technological advancements and growth in investment in R&D activities fueling innovation in new therapies and treatments. At the same time, improving cost efficiency of clinical research operations is a growing concern, particularly in early phase trials with greater uncertainty, more complicated study protocols, shorter study durations and smaller populations.
Although speed and efficiency are critical for all phases of clinical trials, they are especially important in the early phases where uncertainty and financing add additional pressure. Sponsors and CROs alike need to quickly validate new therapies and treatments, and if appropriate, move on to the next phase and secure approval as expeditiously as possible.
Today, there are four key requirements for eClinical, and specifically, CDMS technologies. The requirements reflect the environmental pressures to speed up clinical trials and still support innovative science. The four main buying requirements are:
1. Functionality
2. Flexibility
3. Simplicity
4. Affordability
Though the priorities may shift as a team moves a product through development phases, these four attributes continue to be the drivers for purchasing and implementing enabling technologies. As an illustrative example, the table below shows the potential shifting priorities in the course of development. Affordability is a top priority in early phase trials, followed by Simplicity, Flexibility and Functionality. As a clinical trial sponsor moves through Phase II and toward a Phase III trial, complex trial designs may place a higher priority on Functionality and Flexibility. Adaptive design trials may require both to be a priority. If a solution has prioritized these four key attributes, it will be scalable and meet/exceed most requirements – now and in the future.
The Right Solution Means a Quick Build Time
It’s not a question of whether or not an EDC or CDMS can provide value in early phase trials. The question is finding the right solution that enables you to get your study up and running quickly, provides broad enough capabilities to support a wide range of study protocols, has the ability to evolve with you over time, and of course, is cost effective.
There is a misconception by some that it may take longer to build a phase 1 study in an EDC than it will take to complete it. Technological innovations are improving clinical data management solutions every day, and established vendors have the experience to quickly develop a solution for any study.
At Mednet, for example, we estimate the timeline for a Phase I study build as a month or less. In some cases, it could take as little as a few days. There are numerous reasons for the shortened timeframes but one of the most significant is the use of study templates in the Mednet platform. Our templates enable users to reuse or repurpose forms, such as case report forms (CRFs), along with workflows and roles within a trial. This approach significantly reduces study build time and enables reuse of complex information across studies, therapeutic areas, or entire development product portfolios.
Not only does this save you time in your Phase I study, but it saves time when the results warrant moving on to Phase II and III, as you’ll have a consistent, validated and trusted system that people already know how to use. As study designs in later phases increase in complexity, the team gains additional value by reusing complex CRFs, workflows and role definitions. The early investment in a CDMS solution thus becomes an investment in future trials. In this manner, clinical trial sponsors can also begin to institutionalize best practices and realize efficiencies on a much broader scale.
Feature-Rich Platforms Enable Seamless Study Management
Platforms that strike the right balance of core, native features with select integrations of best-in-breed partners deliver the greatest potential to achieve optimal results and cost efficiency.
Improvements in technology have also enabled flexible, feature-rich CDMS platforms that can add value to any clinical study. For example, Mednet can perform real-time edit checks and true cross checks and patient management updates based on your data management strategy, which lead to faster and cleaner initial data entry.
Core native modules remove the complexity of randomization and streamline inventory management, while medical coding and real-time reporting can identify safety signals sooner. Beyond that, follow up visit tables and multiple types of log forms support all types of study designs through a single intuitive database. In addition, as study designs become more complex, a platform that allows for multiple subject cohorts or sub-studies is critical. These features not only help you build your studies more efficiently, but they also give them a better chance of succeeding.
Some CDMS platforms can offer robust feature sets as well as the flexibility to turn critical functionality on and off as needed. This is typically not possible with point solutions that automate one task or group of tasks at a time. The ability to turn functionality on and off also leads to greater pricing transparency. This is helpful to trial sponsors when planning and budgeting for clinical programs. It is also particularly valuable to contract research organizations (CROs) when providing pricing estimates for trials in any phase.
At the same time, as the clinical trial industry and study designs evolve, a platform that is highly flexible and enables integrations with preferred or novel vendors is critical. For example, a later phase or particularly complex trial design may require an advanced reporting tool or analytics platform. Platforms that strike the right balance of core, native features with select integrations of best-inbreed partners deliver the greatest potential to achieve optimal results and cost efficiency.
A Well-Designed Technology Solution Can Grow with You
When you think of the platform you use for later phase research, you may think it is cost prohibitive to use the same platform for your earlier phase studies. However, comprehensive, flexible platforms like iMednet provide scalable pricing and a menu of modules where you can implement only what your study requires, while also enabling integrations as needed. This type of solution can support the requirements of both early and later phase studies, while also providing pricing flexibility and transparency, so you only pay for the modules you need. It can also smooth the transition to later stage trials while masking the complexities of powerful functionality behind simple user interfaces.
Comprehensive, flexible platforms offer a unique balance of the flexibility and scalability that clinical research demands. As the requirements for the suite of tools needed to support clinical trials continue to change, flexible platforms with native applications offer much-needed underlying consistency, while also allowing for integrations with preferred partners for key study processes. This flexibility is vitally important as the number of data sources continues to increase and study designs become more complex.
Enabling Flexibility Throughout Clinical Trial Phases
Comprehensive, flexible solutions have emerged as the category that can span all phases – from small, relatively simple Phase I trials to large, complex Phase IV trials. These platforms are typically easy to set up, and provide a simple and uniform user experience while addressing the challenges of streamlining complex trials and still being able to support innovative late stage trial designs. As Gartner² suggests, these unified platforms can also “maintain a unified architecture and data model” while balancing feature depth and platform breadth.
These platforms make it easy to collect more data, whether through a study extension, adding patients to the treatment group or introducing a crossover arm. A flexible, comprehensive platform can make it easier and seamless to perform a variety of study tasks and processes in later phases, such as adding randomization or the introduction of an adaptive design. When combined with the ability to integrate with best-in-breed partners, it delivers an optimal end-to-end solution for all study types and phases.
A platform that strikes a balance of unified capabilities, while still enabling integrations to empower research organizations to adapt to emerging demands, provides the greatest value for all phases and types of clinical trials.
A successful clinical development program requires quick and accurate evaluation of safety and efficacy. A unified eClinical solution centered around a robust EDC and comprehensive, native CDMS, while also enabling integrations is more equipped than ever to support studies of all phases and do so effectively and efficiently. As Gartner also notes in Market Guide for Life Science E-Clinical Platforms, “…the unified platform can provide clinical users faster integration between point solutions, holistic platform performance metrics and reduced support complexity”.³ Yet, as the clinical trial industry evolves, new sources of data emerge and study designs become more and more complex, it is nearly impossible to identify a solution that does everything well – and efficiently – across the technology spectrum. A platform that strikes a balance of unified capabilities, while still enabling integrations to empower research organizations to adapt to emerging demands, provides the greatest value for all phases and types of clinical trials.
iMednet is an eClinical solution built around a robust EDC with foundational native applications that provide functionality, flexibility, simplicity One Solution and affordability. It offers a unique combination of platform breadth and feature depth. This combination positions the clinical trial team for success today while simultaneously investing in later phase efficiencies. Their common experience with tools, processes and terminology create a strong foundation to address later stage trial complexity and increased trial size.
eClinical solution vendors will continue to innovate with new technologies that optimize clinical trial processes. As the industry evolves, new solutions and features will be required to meet the needs of increasing complex and evolving study designs. Solutions that strike the optimal balance of investment in core native capabilities and enabling integrations provide efficiency, flexibility, value and the greatest potential to deliver overall success. Vendors who understand this and have a strong vision and ability to execute on it will help to lead the industry toward greater clarity of evolving requirements. Mednet has the vision and the necessary organizational infrastructure and expertise to turn our vision into a reality.
¹ Grandview Research, eClinical Solutions: Market Estimates and Trend Analysis From 2014-2026, p.46, accessed 24 January 2020.
² GARTNER Market Guide for Life Science E-Clinical Platforms, p.7, published June 21, 2019
³ GARTNER Market Guide for Life Science E-Clinical Platforms, p.7, published June 21, 2019
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