Grant Dietrich, Vice President, Strategic Partnerships

 

This post is the third update in our larger series, The Art and Science of Successful eClinical Project Delivery. Read our previous posts on user acceptance testing and project management.

As a seasoned clinical trial professional, my guiding philosophy for project success can be summed up simply: “If you focus on the customer throughout the project, the rest of the pieces generally fall into place.” With this customer-centric mindset comes an inherent focus on needs, timelines and communication.

It sounds lofty enough, but what does this really mean?

Focusing on the customer begins by looking at the big picture of drug development, and where we, as an eClinical vendor fit into our customer’s clinical trial ecosystem. Take the role of IRT and eCOA.

While IRT and eCOA play important roles in a clinical trial, their contribution to the overall clinical trial budget is in the single digits. A small piece of the pie, if you will. However, if something goes wrong with either system, it can be a rate limiter. Patients don’t get randomized or dosed. Missing data impacts regulatory submissions.

You hear “More than a vendor, we’re your partner” quite a bit in this industry. YPrime embraces our role as vendor, partner, service provider regardless of the label. We bring expertise and guidance to the small, but critical part of the trial. We also know that service and support is equally, if not more important than the technology provided.

So much in clinical research depends on human efforts.  That’s why the best clinical software focuses on the human perspective. Effective software design and functionality must reflect real-world scenarios of the sponsors, their patients, and the clinical sites who conduct the research.

The same ethos also drives our product development decisions. Consider the evolution of eClinical providers over recent years. Everyone specializes on a specific function in data capture. The systems that have emerged (think EDC, CTMS, safety, ERT, eCOA) are not integrated and incompatible.

Clinical teams live with a variety of data sources and restrictive supporting infrastructures. For any given project, most clinical teams work with 1-2 CROs, multiple vendors and hundreds of sites. The infrastructure required to manage the combination of internal and external systems is still built on point-to-point integrations, which represent a big risk to data integrity, quality, speed and productivity to sponsors. At the site level, the proliferation of systems has lead to more work and increased potential for errors.

Over the life of a clinical trial, hundreds of thousands of records will be created from transactions across EDC, lab, IRT, and eCOA systems, among others.  A typical error rate of less than 0.1% may seem innocuous, but within point-to-point integration platforms, data errors have a compounding effect. If one transfer fails, data flows for every connected system may be affected.  Even errors within an acceptable range can cause a data traffic jam and worse, a snowball effect.

Multiple data sources, clunky point to point integrations, and data errors were all behind the idea that is now known as YP Connect. In short, because data management doesn’t have to be as complicated as the industry makes it.

YP Connect is a vendor-agnostic cloud-based integration platform. YP Connect standardizes data flow processes between systems, eliminating the need for data transfers and custom programming. This means our competitors could use it.  Since most sponsors manage multiple vendors we believe this will help the sponsor improve their speed to go-live and consistency of data integration standards. This integration platform can be re-used on every study. This is just one fortuitous example of turning a customer pain point into a product.

Without operational support and product development, customer focus is an empty slogan. At YPrime, we aim to weave it into everything that we do. It’s an ongoing process that’s takes a long-term commitment, much like continuous improvement, but we know it starts with the values you build into your organization. Stay tuned as we report on our progress.