Chris Dailey

	A clinical trial is a complex ecosystem that includes systems, processes, internal and external stakeholders, and technology providers. Integrating these vital elements into a cohesive whole can be the key to a trial’s success.

Defining the State of the Art for One Trial or Many

	Nearly 100% of our clients’ trials have at least one integration. While the IRT system might not be the largest point in an eClinical ecosystem, it is one of the most important, because you’re dealing with both patient safety and the fundamental integrity of the study data. And while as the IRT provider we don't manage the physical inventory, we are the system of record for where it goes, and under what circumstances it can be allocated to a patient.

	The level of integration depends on the needs of the trial and the long-term goals of the sponsor. If a sponsor requires an integration for more than one trial, understanding their pipeline enables eClinical technology providers to develop a standardized, repeatable process the sponsor can leverage again and again. 

	On the quantitative side, a clinical trial has a period when the sponsor is determining if they have good potential candidates. On the qualitative side, the sponsor is wondering how best to adhere to trial requirements. Protocol by protocol, these issues can change, but the more you can tie a trial together through integration, the smoother and safer it will be.

	When it comes to arguments about using the best commercial approach, we believe that while speed is important, what matters most is the integrity of the system, the value it delivers, and the assurance that patients are receiving the correct medicine at the correct time. 

	Integrations grow and evolve. Sponsors and CROs have to be prepared to make an ongoing investment to achieve continuous improvement. The most successful sponsors and CROs take a long-term view. They look for the right science and technology, as well as the best commercial approach. 

	While many Emerging BioPharma (EBP) might not be conducting multiple trials, we still recommend early engagement to build a quality integration strategy. With these organizations, we recommend a more hands-on approach to help them review their trial(s) holistically and determine how they want the data to flow. Early decision-making around IRT and other systems can determine how these components fit into the sponsor’s broader ecosystem.

Capturing Opportunities to Leverage Integration and Manage Complexities

	Beyond the day-to-day efforts of conducting a trial, there are important opportunities sponsors and CROs can leverage through meaningful integration, including:

	Risk Based Management – Integration that includes an IRT system can eliminate incorrect dosing, which is one of the most risk-laden components of any trial. Without quality integration, disruptions in data being collected from various systems in the trial can result in safety risks such as to dosing calculations, or wasted visits. A seamless integration eliminates these risks because the sponsor always has the information regarding where and when it is necessary.

	Supply Chain – Sponsors are increasingly interested in the process behind the supply side of trials. As a result, we’re seeing supply chain partners shift their integration strategies and modernize their approach by automating through platforms including IRT. Including these important supply chain factors in global integration strategies can eliminate the possibility for error and disruption, by removing the need for manual oversight of the underlying supply chain and warehousing structures. 

	Virtual Trials – Trials are getting more complex, and integrations are becoming more complicated, especially in the virtual trial realm. One of the more challenging aspects of integration is incorporating behavior into another part of the trial ecosystem, and having those integrations happen in real time. Today, we’re seeing simplistic data transfers such as FTP give way to more complex integration behavior. Real-time response is necessary from Patient-to-IRT-to-Supply Chain, as we’re experiencing with virtual trials. And, more clients are adopting a direct-to-patient model to make it easier for patients to participate in trials.

	Big Data – Big data and data analytics are continuing to play an evolving role in clinical trial integrations. The availability of new analytics tools and an increase in data sources is encouraging sponsors and CROs to take a data-driven approach to decision making, as the FDA turns to big data to accelerate clinical trial efficiency and drug development.Over the next 3-5 years, we expect to see data and metadata  gathered in clinical trials providing deep insights into the operational effectiveness of the clinical trial in real time, as well as the exponential growth in captured, usable data, as the granularity of information grows from connected devices and virtual solutions.

	We encourage all sponsors and CROs to take a strategic view of how to make an eClinical ecosystem function at its highest level. Thinking outside timelines about data flow across systems, and reviewing all of the elements holistically, can create important new possibilities for what can be achieved in a trial. 

	Integrations are the current state of the art. Working toward better standardization enables sponsors and CROs to eliminate human error, prevent business disruption, create repeatability, ensures efficiency and quality, and keep patients safe.

) is Vice President of Global Technology and Product Management; and Chris Driver (

) is Enterprise Architect, at Cenduit LLC.

Articles

Vice President of Global Technology and Product Management, Chris Dailey, and Enterprise Architect at Cenduit LLC, Chris Driver, encourage all sponsors and CROs to take a strategic view of how to make an eClinical ecosystem function at its highest level.

Chris Dailey

Articles

Re-Imagining Integration for Quality Clinical Trials