Transforming Clinical Research with a Site-centric Approach

Shree Kalluri
March 27th, 2019

This morning, I had the pleasure of delivering the keynote to kick off the 27th Onsemble Conference where we’re hosting a record number of attendees and organizations to talk about a site-centric approach to transform clinical researchWhen we started this conference more than 13 years ago, I dreamed of this day – of our conference reaching this magnitude. We’ve sold out at 290 attendees from 71 unique organizations with an impressive 134 attendees that are brand new.  

That’s why I couldn’t be prouder to share with you what I shared today at the conference.    

Where are the gaps? 

We’ve been working for 19 years with the site community to improve clinical research, and we are now reaching an inflection point where we are going to bridge the gap and work with sponsors to transform clinical research. We’ve made amazing progress over the years, but expectations are higher, and the bar has been raised. Despite increased adoption of sponsor-driven technologies, clinical research challenges persist.  

So, the question is: how do we continue to improve clinical research and meet those expectations? 

Our answer: we invert the focus.   

Inverted Diagram

From one trial at a time to a site-centric, portfolio-based approach.  

Sounds good, right? And where you may have heard this before – this time, it’s a reality.   

We are excited to share that we have launched several pilot projects that are in motion, already proving out our vision.  

Trial Data Exchange 

Through our Trial Data Exchange, we are giving sites and sponsors the ability to exchange operations, regulatory, and clinical/source data securely to improve clinical trials by making informed decisions with real-time data. We’ve been so fortunate to collaborate on this project with the best in the industry including Yale University, Duke University, University of Michigan and Washington University at St. Louis, allowing us to meet the true needs of sites.   

The first project in motion is our exchange of investigator site files through Forte eReg which is a reality today, and in the next couple months, we will be launching multisite functionality so that coordinating centers can manage multi-SITE IITs.

Our second project involves clinical data with our 21 CFR Part 11 compliant EDC, Forte EDC. We’ve been collaborating with top institutions like Yale, University of Nebraska Medical Center, Moffitt and University of Florida to build a labs interface with sites’ local systems, reducing the amount of time and data entry error for the sites. In the next phase, we will provide standard interfaces for sites to send data from Forte EDC directly to sponsors and CROs.

Our third project focuses on the operational data collected on a day-to-day basis with clinical trials. Sites with OnCore today have real-time visibility to improve their operations, and we are working on Study Progress which will also give sponsors real-time visibility into the progress of their trials at sites to help identify issues and increase efficiency.  

Comparative Analytics 

Shifting to enhancing the site-sponsor relationships while working together in clinical trials, we focused on Comparative Analytics  

We started this project many years ago with our Benchmarks software that gives our customers the ability to anonymously compare their performance to the aggregate of other sites. And now, we want to take a similar approach to help sites improve relationships with sponsors by having informed conversations to make better decisions.  

Our first project under this umbrella includes a pilot with the University of Michigan to develop Sponsor Scorecard where sponsors can see a dashboard of important metrics that help inform conversations and provide information to help move projects forward.  

What’s next? 

We believe that when both standardization and modernization are applied, trial focus can be re-shifted to prioritize patients and on the research itself, versus spending an abundance of energy on operational frustrations. Lines of communication between researcher and sponsor are also made more transparent and clearer, giving stakeholders the ability to track progress in near real-time and communicate in a way that’s productive, consistent, and patient- and research-focused. 

Two weeks ago, the FDA put out a special statement from out-going commissioner, Scott Gottlieb. One paragraph caught my eye: “Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations. In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable. We appreciate that scientific and technical complexity is a real and ongoing challenge, but industry and academia also need to invest in and leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise.”  

Our Commitment to You  

We know it’s hard to change – but we agree that the importance of adopting the new innovations is paramount. We are doing everything we can to collaborate with customers and make it as easy as possible.   

  1. We’re are inviting institutions that want to collaborate on eReg and EDC and bring sponsors to the table.  
  2. We are providing our full managed infrastructure so that upgrades and taking on new innovations is a business decision and not an IT decision. By the end of this year, we expect 1/3 of our customers to be officially transitioning to cloud-based enterprise clinical research software.  
  3. We are also making it easier by helping our customer integrate all their systems as this is where the breakthrough efficiencies happen. OnCore is at the heart of all your clinical trial operations, but we want it to enable other systems for increased efficiencies. From your IRB to your EHR and your financial systems, we are working hard to make these interfaces a reality. 

The future in clinical research is changing. A technology-forward approach empowers both researcher and sponsor to focus on the work and their commitment to finding cures, heightening the ability to do more, managing more effectively, and getting clearer results so they can forge ahead with more confidence in the research itself.  

We’ve always collaborated closely with customers, and as we pave the path for the future, we will continue to work alongside those doing the work, so we can enable them to transform clinical research.  I’m looking forward to connecting with our customers this week and learning even more from institutions that are driving change in our industry.