Improving Clinical Trial Efficiency: Interview Highlights from the Note to File Podcast

In a recent interview with Brad Hightower and Denali Rose on the Note to File podcast, our CEO, Chris Venezia, discussed the often-overlooked operational challenges in clinical trials. Here is Chris’s refreshing take on making clinical trials more efficient and user-friendly. 

What's the problem we actually need to solve?

Plain and simple, sites are inundated with information, tasks, and technology to execute the very serious business of world class research. It may seem like sites should be better supported, but simply organizing these three things is one of the biggest challenges of our industry.  

While the clinical trials industry is rife with exciting innovation, many sites cannot handle these innovations because execution of the basic plot of research is still hamstrung by: 

1. Too many disparate documents and technologies.  
2. Unclear and ever-changing information.  
3. Delays in getting questions answered. 

The allure of innovative technologies is real, but we must lower the blood pressure to execute the fundamentals and deliver a better experience for sites. So we first have to address these operational hurdles. 

Why do we need to start here?

A site in chaos is only the tip of the iceberg. While disorganization is inflicting visible stress on the site staff, it’s also leading to larger problems below the surface. 

When site engagement suffers, patients suffer 

An invisible string connects site engagement and patient engagement. Even the most competent site staff with the best of intentions will fail to keep patients engaged in a trial if a study isn’t managed well.   

To take it a step further, with the stigma surrounding clinical trials, it's critical to equip site staff with information that is easily accessible to maintain patient trust. Hesitancy and delays in gathering information or knowing what to do aren’t acceptable in healthcare; why should we not expect the same experience for trial participants? 

A secret reward system 

Sites work with many sponsors. On which studies do you think they’ll work the hardest? The studies in disarray and confusing to conduct, or those that are organized and well-managed? 

Sites are too often handed the pieces of a study and left to figure out how to run it. So, the Sponsors who prioritize site engagement are profoundly rewarded, ultimately improving overall study success.  

Small issues, big impact 

Think it takes a major problem to derail a study? Think again! Every day, studies are put at risk because of basic, small, and preventable things. CRA turnover, data quality issues and deviations lead to errors and delays, slowing down the trial, and costing more money.   

The bottom line is that improving site engagement helps to manage timelines, reduce errors, eliminate patient drop-off, and improve outcomes. 

How do we improve site engagement, really?

On the podcast, Chris Venezia said, “It is the biggest challenge getting people to understand that some of the modern, basic technology can actually move mountains and make people much more efficient in their day-to-day.”  

That being said, let’s start with the basics and help sites get organized—truly help them, with ample support and configuration that meets their needs. 

Resource centralization & document search 

The more places there are to look for information, the harder it is to find. Site staff lose precious time sifting through lab manuals, protocols, overviews, and docs full of random (yet important) notes. On top of that, there are numerous study-specific technologies to be managed and sequenced.  

Let’s first organize everything into one centralized, purpose-built command center (ahem...not SharePoint), but let’s also make it better with search capability. Rather than expect sites to remember what information is in which doc, or to scour every resource one by one with the archaic Ctrl + F, why not give them the power to search across all documents with a single search inquiry?   

Now...how else can we improve the site experience? 

Organized communication flows 

Many sponsors lack a proper communication structure, leaving site staff lost and uncertain about: 

• Where to go to find information 
• How quickly they can get the information 
• Where important information got buried along the way 

Structured communication flows with options like direct chat, email integration, link sharing, and organized conversations can simplify the way in which sites gather and receive information. But here’s the mind blower: sometimes you don’t have to communicate at all! If content and information are simply updated – e.g. like a new CRA – you don’t have to send an email.  It’s like opening your weather app. It’s always on the right day.  

Custom Configuration and Modification 

Even when helping sites address fundamental challenges, the technology needs to be adaptable to a sponsor’s approach. Additionally, amendments and changes are inevitable, so modification of any enabling technologies cannot be rate limiting. Ultimately, a solution needs to be adaptable to the wide variety of partners and point solutions in play, while also being flexible down to the site level. 

Get back to the basics with ProofPilot

ProofPilot’s Site Hub helps get sites get organized with a centralized Study Content library, a Study Details repository, and quick access to study and vendor contacts. 

With Study Sync, we do away with “it’s in an email somewhere” with standardized communication flows with integrated chat, link and attachment sharing, and email integration.