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Catherine Hall, VP of Data and Quality, endpoint Clinical

As Clinical trials evolve, the processes within the trials evolve and this in turn encourages the technology that supports to change. The reverse is however also true, as technologies innovate and evolve, they propose improved models of how to conduct clinical trials. In an Interview with Cat Hall from endpoint clinical we explored the current and future trends in technology.

1. Please provide us with some background information about endpoint Clinical, including the products and services it offers to the pharmaceutical sector.

Endpoint Clinical provides technology solutions to the pharmaceutical sector predominantly focused on randomization and trial supply management (IRT). Endpoint’s flexible technology platform enables sponsors to design and deliver software that enables patient enrollment, dispensation, streamlined supply logistics, and advanced analytics facilitating the conduct of Phase I – Phase IV clinical trials. The technology is paired with experienced service and project management staff that facilitate the delivery and support of the study enabling sponsors, sites, CROs and other technology providers to effectively utilize or integrate with the platform. All products and services are geared towards enabling an integrated, seamless experience for everyone participating in the trial.

2. On issues like patient-centricity, drug delivery systems, and global manufacturing, what guidance would you offer to companies as they start to develop biopharmaceuticals?

Each sponsor is unique. Different considerations go into the technology selection and direction of each company starting to develop biopharmaceuticals. What are my organizations main indications? What is my existing vendor and technology landscape? How large is my company? Do I leverage a full-service CRO? Do I have an experienced internal supplies or IT department? Understanding the current and future state of your organization will help you make the right-sized technology decisions. It is important to find good partnerships that will help enable your company to succeed. The e-Clinical technology landscape contains many vendors and integrated solutions so having someone to help plan your technology footprint is important. By selecting the right systems, your end-to-end clinical trial process will be smoother resulting in high quality data, simplified user experiences, better insights, quicker analysis, and ultimately a better outcome for your clinical trial.

3. What modifications do you believe the use of DCT has brought about in patient attitudes?

Clinical trials will continue to be a hybrid combination of at-home and on-site experiences for the patient. Increased accessibility, high convenience, and telemedicine will help alleviate burdens placed on patients participating in studies. The ability to conduct trials in a hybrid fashion, provides patients with the best of both worlds, convenience when needed, but also the comfort of a doctor to patient relationship face-to-face. Technology will enable these experiences to occur while maintaining the quality and integrity of the trial design.

4. Are there any prominent technologies that are being used in trials now?

What would their impact be on the future? Many different technologies are currently being utilized in clinical trials, but some common industry trends are leaning towards advanced processing and automated understanding of vast amounts of information. The volume and velocity of clinical data is continuing to increase as more software systems are introduced into the clinical workflow, so incorporating technology to enable access, integration, and processing of this information is vital. Cloud providers, such as Microsoft Azure, make processing and integrating data easy by providing simple interfaces for AI, ML, NLP, integrations, data transformation, and movement. Operating in a cloud native or hybrid framework is important for technology providers to ensure they can easily adopt new technologies as they come online.

5. How can inaccuracies in real-time data collection be reduced?

First and foremost, it is having a clear understanding of your data lineage, and knowing what is considered source data, where having an integrated set of technology providers helps to eliminate the burdens of data reconciliation. Secondly, it is developing the right skill set to understand how the technology works and where the risks to the data lie. Technology helps to accelerate and augment processes, but if not intelligently designed in the ecosystem of data exchange, technology can introduce issues that compromise the integrity of the data. It demands those that know how best to design the system so that they seamlessly work together and reinforce the integrity of the data. Finally, to reduce issues, there must be the governance of the data in place. What are the quality indicators of the data, how will it be measured, and how often to support confidence in the data from input to output.

6. Are there any barriers preventing clinical studies from adopting new technology?

The biggest hurdle to overcome in adopting new technology is the unknown. The industry is traditionally risk adverse especially around data because at the end of the trial it is all about the data and what it tells us if the trial was a success. Stepping into a new technology raises fears of the unknown that may not be understood until the end of the trial. The other major hurdle is resistance to change.

7. In which areas of clinical trials does Endpoint Clinical see room for innovation?

In short, everywhere. IRT was one of the first technologies to help support how a clinical trial is conducted and has only grown from there. There is an interesting dynamic between clinical trial design and IRT. Because of a need for the IRT to do something new, clinical trial designs changed and because clinical trial designs changed, IRT has changed. For example, the first IRT systems only managed Randomization, but because they did, clinical supply management evolved from manual shipments of patient-specific and visit-specific bottles to on-demand, automated shipments of bottles with kit numbers. And because of this change supporting a global trial across hundreds of sites was made possible, which lead to changes in how patients are recruited, that then lead to gathering patient feedback on trial designs. Thus, for each evolution of trial design, IRT evolves to help support them.

8. What are the product innovation trends of the future that will influence clinical trials?

Commercialized software has paved the way for product innovation within clinical trials. Advancing clinical trials will start with applying best practices and forward-leaning cloud technology towards challenges within the clinical trial industry. As patient-centricity, convenience, and trial designs evolve, the need for mobility, interoperability, and flexibility will continue to drive products forward. Sponsors, patients, and doctors will experience consumer grade software solutions that will seamlessly work with their everyday jobs. As part of this process, data will more easily be able to be leveraged across systems in an automated, intelligent fashion providing insights into trial designs, logistics, outcomes, and analysis.

9. What are some of the major changes you see in clinical trials over the next few years, based on your experience?

The industry has faced major disruptors recently with the COVID pandemic, devastating hurricanes, and the Ukraine/Russia conflict. Each event has had a lasting impact on the industry, and  will inevitably bring further changes that will provide increased flexibility in trials. We have only begun to see how we shift to allow a trial participant the flexibility they need in their lives whether due to placement in quarantine or a need to evacuate their home. Today sponsors focus on picking technology before the trial has started and feel stuck when it isn’t the right as the trial progresses. The need for flexibility to rapidly adapt to changes will inevitably spark further innovation.

10. Do you anticipate any other market problems or developments that will have an impact on this industry sector?

Please elaborate. We see this already. Due to the need for countries to invest in other areas such as defense and economic support, basic research funding has diminished. This then feeds into the industry to have to invest in this area themselves which will further increase the cost of new medicines in a world that is under constant pressure to decrease those costs. Another trend to watch is the concern over personal data and the differences in regulations across the world. Many countries are asking that data never leave their geographical borders. This is a challenge for a global clinical trial that must aggregate worldwide data for trial analysis. From a clinical supply perspective, the change in global temperatures introduces a new challenge of how to ensure trial medication is being stored according to the label, especially when it is delivered directly to the trial participant.

11. What are some future industry challenges that pharmaceutical companies might experience that Endpoint Clinical is ideally suited to handle?

At Endpoint we focus on the voice of our customers and their stakeholders. By working closely, and listening objectively, we better understand the pain points in a variety of trial designs which inspires us to think outside the box and bring new solutions to bear. As a result, we can promise our clients that no matter how their trial design evolves, our system and our teams will support it. Achieving seamless integration across new and evolving technologies takes an investment of resources, and as a result, we actively engage with other providers to anticipate future trends that shape our product roadmap. We also are continuously exploring the landscape to bring transparency, analytics and insights to the data within the IRT.

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Author Bio

Catherine Hall

Catherine Hall is the VP of Data and Quality at endpoint Clinical During her 20+ year career, she developed notable expertise not only in clinical supplies but also in the design and implementation of e-clinical technologies. Cat has a passion to bring the customer voice into shaping the future of IRT.

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