Lessons Learned From Delivering Over 1,000 Clinical Trials

At Agilathon, we work with industry-leading partners to deliver digital clinical trial solutions in multiple therapeutic areas, including Oncology, CNS, Metabolic, and more. With 15 years of experience completing more than 1,000 studies, we’ve learned how to navigate challenges with digital data collection platforms (including ECOA, EPRO, and decentralized solutions). Overcoming these issues requires forethought and acknowledgement of the process that must be followed to run a successful trial. Here’s what we’re seeing:

1. Engage implementation expertise during protocol design

Clinical trials come in all shapes and sizes. The more complex the study design, the more customized the technology must be. Custom technology takes more time to build, test, and implement. Furthermore, complexity and customization impact quality testing and assurance.

If the level of complexity is not considered in the planning phases, the risk of missing study deadlines increases. Understanding what is needed to maximize patient engagement rather than the limitations or dependencies of technology is critical.

The solution is to have technology experts engaged in the protocol design phase to consider the implementation of patient and site facing solutions. The earlier the tech experts understand the trial protocol and the needs of the delivery team, the easier it is to set accurate timelines, budgets, and software capabilities.

2. Trial protocols change; be prepared

Over the weeks, months, or even years of collaboration on study design, the protocol will change, and the technology supporting the study will need to reflect those changes. This cycle must be factored into the planning; the protocol will change and the software will change — that’s part of the work.

It is key to design your clinical trial workflow to provide flexibility for protocol challenges to minimize data quality issues and trials costs. To mitigate the risk of missing deadlines, it is crucial to work with an experienced tech team who understand how to manage protocol updates and how those updates impact the budget and timeline.

3. Digital clinical technology isn’t turnkey; it has to be customized

When you buy a new iPhone, you can take it out of the box, turn it on, and Apple will do the setup work for you. It would be great if all technology were this simple, but critical technology platforms including eCOA and DCT need to meet the unique needs of each clinical protocol.

Furthermore, technology is constantly evolving. Clinical trial sponsors and operation partners are experts in their own fields and can’t be expected to be experts in every new technology they use. Despite technology innovations, development of the optimal clinical solution to engage patients and collect quality data requires strategic thinking, planning, and logic.

Finding technical experts who have clinical trial experience is challenging. You can hire inexperienced engineers, but in-house knowledge is an edge in a competitive market. Sponsors and clinical research organizations (CROs) will need to lean on and collaborate with technology experts to understand study design and how technology can support and enable better, faster, more-effective trials.

4. Regulations and technology don’t move at the same pace

Regulations exist for a reason: patient safety. We all respect them and recognize their importance, even when they slow down the time to design, plan, and implement a clinical trial. Technology, however, is always changing. You need a technology partner who understands both paces.

At Agilathon, we’ve spent the past 15 years learning the ins and outs of clinical trial regulations and ePRO solutions. We’ve built our company on the premise that in this space, you need to be agile, like a technology company, but prepared for a marathon, like a clinical trial. That’s what we do at Agilathon (agile + marathon = Agilathon).

There are many experts in clinical trial regulations and many experts in software development and technology. What’s unique is a technology partner who is experienced in the regulatory field and who also appreciates the importance of high-quality solutions. In our decade and a half, Agilathon has helped deliver more than 1,000 studies, keeping quality at the forefront of everything we do.

5. Innovation is great, but quality is king

Every year, new companies emerge with cutting-edge technology, and existing technology is upgraded and enhanced with new features, products, and capabilities. While 2020 exemplified the agility of these companies to deliver and scale decentralized clinical trials, keeping the patient at the center and maintaining a quality mindset are sometimes overlooked.

Innovation in this space is inspiring; imagine what the future holds for delivering effective therapies to patients faster. However, we must not be in a rush to implement technology without a rigorous understanding of the patient experience, and we must ensure high-quality delivery and comprehensive testing of the product before putting it in the hands of patients.

What we do at Agilathon

Our team has experience implementing clinical trial solutions by working both with clinical software companies and sponsors directly. Our teams provide scalability, flexibility, and quality for our clients.

To deliver clinical trials efficiently, Agilathon works with your team to execute in three areas:

  • Product development (development and validation)
  • Project delivery (study design, development, and validation)
  • Study enablement (end-to-end support from kick-off meeting to production)

Let’s talk

If your organization needs support standing up a clinical trial, let’s connect. We’re also looking to connect with other partners engaged in producing/managing clinical trials.

Contact us at: contact@agilathon.com

About Clinical Trials Innovation Programme 2022

Clinical Trials Innovation Programme is an invitation-only, premium event bringing together a mix of clinical research professionals and service providers in one stimulating environment.

Join us face to face to learn from the best in the drug development industry and have an opportunity to learn from their experiences. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2022 will feature tailored sessions presented by the leading experts from across the globe.

We are bringing together the best in the industry to help you learn and grow, and accelerate your drug development journey. The experts will include thought leaders and visionaries from Danish Medicines Agency, Bayer Pharmaceuticals, AstraZeneca The Janssen Pharmaceutical Companies of Johnson & Johnson, Travere Therapeutics, Biogen, Vifor Pharma, Medical Products Agency and much more.

Register with us to learn more!