Richard Staub, president, Research & Development Solutions, IQVIA provides insight into CRO trends impacting the industry. For a more comprehensive analysis of the CRO Industry, see Contract Pharma’s Annual CRO Industry Update: Big Data Drives Drug Development Efforts. 

Contract Pharma: What are the significant pharma/biopharma R&D trends impacting CROs and services?

Richard Staub: There is no doubt that clinical trials are becoming increasingly complex. Since 2002, there have been marked increases in the total number of endpoints, eligibility criteria, and procedures required in typical Phase II and III studies, as well as increases in the number of countries and investigative sites required in trials.

We also know that 60 percent of clinical trials end up with a protocol amendment, almost half of all sites end up missing their enrollment obligations, and that 80 percent of trials are delayed, often due to recruitment-related issues.

In addition, with the rise of precision medicine, there’s an increasing demand for innovative ways to conduct trials more efficiently to help biopharma companies who are faced with the high costs associated with developing more targeted therapies and meeting complex regulatory requirements. And timing is critical in this industry.

With these trends, there is opportunity for sponsors to move away from transactional relationships with CROs. Instead, experienced CROs, who have the scale, technology and expertise, are engaged to provide critical insights along the full lifecycle of the studies – including to enhance protocol design, improve site selection, and drive faster patient enrollment.
 
CP: Where do you see opportunities to further engage existing customers?

RS: Traditionally, the industry has relied on past experience to help with trial design and operational decisions, but that way of thinking has also led to potentially avoidable hurdles such as protocol changes and recruitment challenges that add costs and increase delays in the process.  

We’ve invested in a new interconnected approach – that we refer to as next generation of clinical development – that gets to the root causes of trial inefficiencies.

We start with evidence-driven design capabilities leveraging the vast amount of real-world data we have to help shorten study timelines, reduce protocol amendments, and improve patient recruitment processes with more precise targeting. Throughout the process, we incorporate advanced technologies and analytics to improve clinical trial performance, which when combined with our extensive data, enable the deep level of expertise of our people help provide forward-thinking approaches to trial design, site selection, and patient recruitment.
 
We are also investing in transformative technologies to help our customers, sites, and patients. For example, our acquisition of DrugDev has expanded our suite of site engagement tools, including an improved site portal, better site payment capabilities, and eConsent to improve the experience and understanding of patients participating in a clinical trial. Also, through our acquisition of Wingspan, we now have access to a suite of content management solutions that can be applied in almost every part of a life sciences operation—from R&D and regulatory through commercial, manufacturing and quality management.
 
CP: How do you help overcome challenges and delays associated with the growing volume of data in clinical trials and expanded use of real world evidence? 

RS: IQVIA has been managing very large, complex data sets for over 60 years. We see the growing volume of data and real-world evidence as an opportunity to reimagine and develop new approaches to clinical development, speed innovation, and accelerate improvements in healthcare outcomes. IQVIA provides customized solutions for clients leveraging the world’s largest curated healthcare information source, advanced analytics, leading technologies and extensive industry knowledge across diseases, geographies and scientific methods.
 
We are using unparalleled real-world data and advanced technologies to dramatically improve clinical trial performance. Everything we do is powered by the IQVIA CORE™ – a holistic approach that brings together deep domain expertise, unparalleled data, advanced analytics and transformative technology. Through this approach, we can help address root problems in trials, and ultimately help our customers get treatments to patients in need faster.
 
We have invested in an unparalleled amount of real-world data and analytics – over 30 petabytes of data, gathered from more than 800,000 unique data sources. But it’s not enough to just have the data. It’s critical to have the right expertise to review and gain actionable insights from them.
 
Our data scientists are providing advanced analytics of our data through machine learning and predictive modeling to help anticipate challenges before they occur. To aid our data team, we’ve invested in new technologies that are able to handle translating large-scale data quickly enough to influence decision making in nearly real-time. 
 
Throughout all the data and technologies, our people are fundamental to our success. Our teams have extensive institutional knowledge and are experienced in executing trials in more than 100 countries around the world. This combination helps enable and power up how we deliver for our customers to transform clinical development.
 
CP: Are you seeing any new collaboration models with the potential to disrupt traditional    outsourcing? 
 
RS: For decades, clinical trials have utilized a traditional site-based approach. New approaches that utilize advances in technology – such as virtual clinical trials – have the potential to be more cost effective and patient centric.  A virtual clinical trial approach requires in-depth clinical operations and therapeutic expertise, driven by a technology-enabled collaboration across telemedicine, home healthcare, mobile health devices, and other elements. Virtual trials have the potential to reach more patients, enhance patient engagement, and create a more personalized approach that reduces some of the burden on patients. We think this is an exciting development in the industry—for both sponsors and patients alike—as we utilize modern technologies to usher in the future of clinical research.

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Richard Staub is president of the Research & Development Solutions global business unit at IQVIA, where he leads the world’s largest contract research organization (CRO). Supported by high-powered information and technology assets, the clinical experts in R&D Solutions leverage comprehensive, evidence-driven trial design, accelerate site activation and patient recruitment, and optimize trial execution. Richard also serves as chair of the Research & Development Solutions Executive Committee.

Previously, Richard was president of Novella Clinical, a Quintiles company, a specialty clinical research organization acquired by Quintiles in 2013, and the leader of QuintilesIMS’s Global Functional Resourcing business. Joining Novella in 2004, he served as both president and CEO from 2008-13. Under his leadership, Novella became a distinctively agile, results-oriented CRO in the highly complex and fast-growing areas of specialty pharma and medical technology. Prior to joining Novella, he was senior vice president of global business development for one of the world’s largest CROs. Richard’s career in the pharmaceutical industry began at Zeneca Pharmaceuticals in 1989 where he was given increasing responsibilities as a medical and hospital sales representative, cardiovascular portfolio analyst and marketing manager.