Shots: 

• In an insightful interview with PharmaShots, Sujay Jadhav, CEO of Verana Health, discusses VeraSite, a recently launched subscription-based tool for clinical trial site selection  

• To gather real-world data, Verana Health leverages the VeraQ population health data engine and transforms the structured and unstructured data into curated disease-specific modules called QData  

• Currently available in the therapeutic area of ophthalmology, Sujay briefly shares the plans to expand VeraSite to other therapeutic areas  

Saurabh: Can you provide an overview of Verana Health's VeraSite solution for clinical trial site selection? What are its key features?  

Sujay: VeraSite is a new subscription-based tool that offers clinical trial sponsors and contract research organizations (CROs) a quick and secure way to identify practices that possess clinical expertise and a high volume of potential patient populations that are matched to unique study protocols based on real-world patient data. Through our exclusive data and analytics partnership with the American Academy of Ophthalmology (Academy) IRIS® Registry (Intelligent Research in Sight)–one of the largest specialty society clinical data registries in all of medicine–VeraSite sits on top of data from an expert network of ophthalmologists. This offers an unparalleled representation of community practices that serve a diverse ophthalmology patient population across the United States. Our site selection solution also opens up tremendous new opportunities for clinicians and patients to become more involved in clinical trials.  

Key Features include: 

1. A flexible user interface for adding inclusion/exclusion criteria that quickly runs queries 
2. Data visualizations to summarize cohort demographics such as sex, race, ethnicity, and age 
3. A map to display how the cohort is distributed across the U.S., showing relative numbers of potential patients at each site 
4. A set of filters that enable filtering of practice attributes, such as type of research experience 

Saurabh: How does Verana Health leverage real-world data to enhance the process of clinical trial site selection? What benefits will it bring to the clinical trial sponsors and CROs?  

Sujay: Verana Health operates an exclusive real-world data network of more than 20,000 healthcare providers and about 90 million de-identified patients, stemming from its exclusive partnerships with three medical societies, including the Academy’s IRIS Registry. The IRIS Registry contains de-identified longitudinal patient data collected from nearly 16,000 contributing clinicians and more than 2,000 practices. Using our clinician-informed and artificial intelligence-enhanced VeraQ® population health data engine, we can transform structured and unstructured healthcare data into curated, disease-specific data modules, called Qdata®. Qdata helps power analytics solutions and software-as-a-service products for real-world evidence generation, healthcare professional quality reporting, and medical registry data management. With the launch of VeraSite, we are able to use these data capabilities to provide a clinical trial site selection tool that draws on real-world evidence and can provide a comprehensive, real-time summary of real-world ophthalmology patient populations. 

By using real-world data as the foundation for building a clinical site selection strategy, trial sponsors and CROs are able to recruit clinical trial participants far more efficiently than ever before. 

Saurabh: Tell us how VeraSite can help users identify different patient groups. Is it specifically designed for a particular therapeutic area or clinical trial phase?  

Sujay: VeraSite users are able to identify patient groups using filters including specific diagnoses, procedures, outcomes, and patient demographics. Once these cohort filters are applied, participating practices will appear along with counts of patients at each practice.  

Currently, VeraSite is only available for use in the therapeutic area of ophthalmology. However, we do have plans to expand it to other therapeutic areas, including neurology and urology. VeraSite is designed to work for any trial phase, but we expect it to be of interest mainly in phase 3 trials.  

Saurabh: What are the specific challenges you think the current clinical trial site selection process has and how will VeraSite overcome them?  

Sujay: Globally, more than 80% of clinical trials fail to meet enrollment deadlines, resulting in costly extensions, the addition of new study sites, or outright study failure. In addition, research we published last year found that clinical trial populations often do not mirror the real-world patient populations they are seeking to help treat. 

Reasons for this include: 

1. Enormity and complexity of the challenge of safely bringing a new drug to market. 

2. Countless challenges around study design, funding, patient access, and patient engagement.  

3. Structural inefficiency of the traditional approach to study design and patient recruitment.  

VeraSite was designed to change that status quo by implementing a real-world data-driven approach to the clinical trial site selection process. With VeraSite, clinical trial sponsors and CROs are able to guide their clinical trial site selection strategy based on real-time, real-world patient data. This allows them to identify participating sites that are seeing specific patients with particular patterns of diagnoses, procedure history, visual acuity results, detailed demographics, and several other variables. 

Saurabh: How does Verana Health ensure the reliability and quality of the real-world data used in its solution? Are there any limitations or measures taken?  

Sujay: VeraSite is powered by high-quality real-world evidence. As the exclusive data curation and analytics partner of the Academy’s IRIS Registry, we have access to de-identified longitudinal patient data. Through careful curation and clinician guidance, we are able to turn this data into high-quality insights that power our VeraSite tool. Our platform includes many checks to ensure data quality.  

Saurabh: Are there any regulatory guidelines that Verana Health's solution complies with, particularly in terms of using real-world evidence for clinical trial site selection?  

Sujay: We take our responsibility to be good data stewards very seriously. We have strict controls on how patient data is accessed within Verana Health. For datasets that are made available externally, including VeraSite, we use expert determination to certify that they are de-identified in compliance with HIPAA.  

Saurabh: What is the future that Verana Health has in mind for developing these real-world evidence solutions? Will there be any upcoming features or expansions for VeraSite?  

Sujay: We have many planned updates to VeraSite, as well as its companion product for clinicians–Verana Trial Connect–which provides support during the patient recruitment phase. The updates are aimed at helping both life sciences companies and clinicians quickly recruit the best patients for trials. We also have a product line aimed at providing insights into our real-world datasets, expanding beyond our currently available market tracker. Stay tuned for more! 

Image Source: Canva 

About the Author 

Sujay Jadhav

Sujay Jadhav is the Chief Executive Officer at Verana Health where he is helping to accelerate the company’s growth and sustainability by advancing clinical trial capabilities, data-as-a-service offerings, medical society partnerships, and data enrichment. 

Sujay joins Verana Health with more than 20 years of experience as a seasoned executive, entrepreneur, and global business leader. Most recently, Sujay was the Global Vice President, Health Sciences Business Unit at Oracle, where he ran the organization’s entire product and engineering teams. Before Oracle, Sujay was the CEO of the cloud-based clinical research platform goBalto, where he oversaw the acquisition of the company by Oracle. Sujay is also a former executive for the life sciences technology company Model N, where he helped to oversee its transition to a public company. 

Sujay holds an MBA from Harvard University and a bachelor’s degree in electronic engineering from the University of South Australia. 

Related Post: Nathan McCutcheon shares highlights of Qpex Biopharma’s acquisition by Shionogi