Technological advancements and growth in investment in R&D activities is 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, it is 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.
Why Using an EDC in Early Phases Boosts Study Efficiency
Historically, early phase trials have used paper - it was faster to deploy, required limited training and is low cost.
However, advancements in EDC 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 EDC reduces the amount of time needed for training.
Using an EDC solution in the early phases can have significant value throughout the entire development and clinical trials process. Dynamic controls and alerts improve data quality and real-time 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.
The Right Solution Means a Quick Build Time
It’s not a question of whether or not an EDC can provide value in early phase trials. The question is in 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 evolving EDC platforms every day, and established EDC vendors have the experience to quickly develop a solution for any study.
At MedNet, for example, Kelly Ritch, VP of strategic partnerships, estimates that a phase 1 study build would take a month or less. In some cases, it could take as little as a few days.
Not only does this save you time in your phase 1 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.
Unique Features Lead to Seamless Study Management
Improvements in technology have also enabled flexible, feature-rich EDC platforms that can add value to any clinical study. For example, iMedNet can perform real-time edit checks and true cross checks, which leads to faster and cleaner initial data entry.
Integrated modules remove the complexity of randomization and streamline inventory management, while medical coding and real-time reporting can identify safety signals sooner. Beyond that, dynamic grids and multiple types of log forms support all types of study designs and multiple subject cohorts or sub-studies through a single intuitive database.
These features not only help you build your studies more efficiently, but it gives them a better chance at succeeding.
Unified Platforms Can Grow With You Every Step of the Study
When you think of the EDC 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, unified platforms like iMedNet provide scalable pricing and a menu of modules where you can implement only what your study requires.
This type of solution can support the requirements of both early and later phase studies, while also providing pricing flexibility, so you only pay for the modules you need.
A successful clinical development program requires quick and accurate evaluation of safety and efficacy. EDCs are more equipped than ever to support studies of all phases, and do so effectively and efficiently.
So, the next time you're shopping for an EDC platform, consider a solution that adapts to support every phase of your clinical research.