Partnering for Quality, Innovation and Expertise – My Conversations with Industry Leaders

 
 

At Cenduit, our motto is “Do the right thing, always.” Part of living up to our motto means staying externally focused, and being hyper-aware of where we can drive innovation, quality and expertise to improve clinical trials and patient outcomes.

Recently, I had the great pleasure of visiting with several clients and opinion leaders on a year-end “listening tour,” to discuss their issues and goals for 2019 and beyond. Sitting down with clients and other influencers is a great way to understand, anticipate and address the industry’s challenges and opportunities. 

The most common thread running through my conversations is that innovation remains a significant pain point in biopharma.

Big pharma especially is very forward-thinking in how to approach technology, and often struggles to get eClinical technology providers to keep up, or more importantly, to drive the discussions and discovery. Biopharma companies are frustrated because while technology providers have access to different resources, can move faster, and be more nimble, they aren’t doing enough to create useful innovation – especially around drug supply. The irony is that many technology providers are waiting for sponsors and CROs to tell them what they want versus working together to develop a solution.

Our industry has a responsibility to keep beneficial innovation moving forward, whether it’s related to products or services. Based on my conversations with clients and other industry opinion leaders, here are several of biopharma’s key “asks” for 2019, along with our recommendations for how eClinical technology providers can deliver:

Seamless Integrations Across the eClinical Landscape to Ensure Smooth Navigation – With a quality clinical study integration, the trial experience can be more seamless for all stakeholders – especially patients. As experts, we need to engage our clients so that they see immediate value, and experience the relief of knowing we’ll do the heavy lifting.

As a recent example, one of our PMs took over an incredibly complex study, including managing timelines and directing traffic with other technology providers. The other providers were unable to support the complex calculations required from the data their systems captured. Cenduit partnered with them to understand their systems, requirements, and data captured. Our team’s expertise in clinical trials enabled us to make recommendations to the sponsor about the data that should be captured in each provider’s system.  We based these determinations on the perspective of the end user, and for streamlined data analysis throughout the life of the study. By partnering with the other providers, Cenduit was able to design multiple integrations at various time points in the study to transfer the raw datasets to the IRT database. Then, our team used the raw data to run a sequence of intricate daily calculations to detect patient eligibility. Because of the frequency of the transfers and significance of patient safety, our team implemented various safeguards to make sure each transfer of data was successful, and contained the required data.

Demonstrate Speed and Flexibility to Handle Changes – A common thread running through my conversations was the need for more speed and flexibility from technology providers and their solutions. Protocols are getting finalized much later, and everyone involved – sponsors, CROs, partners – must be able to react quickly as changes occur. Often we’re asked to make changes when a study is in full swing because someone at the sponsor or CRO makes a data fix, or an event occurs that requires a relatively significant change to the protocol. Imagine a sponsor is running an oncology trial, and going with four doses. Perhaps during Phase II, as they’re getting ready to begin Phase III, they learn that one of the high doses is dangerous and they have to drop it, or make another major change. It’s not uncommon for a change to result in a significant delay if the technology providers cannot move quickly and efficiently. Technology providers need the speed and agility to respond when unexpected events like this occur late in a study phase. Being able to react quickly and with quality oversight provides an incredibly powerful benefit to sponsors. 

Service Excellence 24/7/365 for 1st Resolution – Sponsors and sites often have difficulty getting to the right support person within many of their technology providers. When sponsors and sites are in the middle of a study they don’t want to leave a message or wait while someone looks for the right person to answer their question. The issue could be as simple as confirming or correcting a drug shipment, or something more nuanced related to dosing and titration. Studies happen in real time, so sponsors and sites need better answers in real time.

Share the Risk, Share the Reward

Finally, forward-thinkers notwithstanding, we work in a sometimes conservative industry. It takes a certain amount of bravery along with calculated risk for a sponsor to be among the first to adopt a new eClinical technology that doesn’t have a proven ROI. Yet, we limit how much innovation occurs if sponsors aren’t willing to get ahead of the curve. Sponsors who try new approaches and defer ROI are more likely to reap the benefits of innovative technology. When sponsors, CROs and technology providers share the risk, and adopt and refine new eClinical solutions, everyone involved gets valuable, real-world experience that ultimately can create more shared value.

Over the next year or so, our industry will continue creating and adopting technology that creates a viable digital health landscape that will incorporate the patient more and more into clinical research. Technology providers must stay in touch with our clients and colleagues to create standards for this new era of clinical research. I’m looking forward to my next listening tour in spring 2019, and to sharing what I learn from my conversations. Let’s continue to work together to innovate eClinical technologies so we can deliver new medicines that improve quality of life for all of us. 

If you’d like to meet during my next listening tour, email me at Jennifer.aquino@cenduit.com. I’ll look forward to hearing from you.

Posted by Jennifer Aquino, Chief Operating Officer

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Supply Chain, IRT SystemsCenduit