Real world evidence and virtual trials are playing a much larger role in drug development today. Both generate vast amounts of data and the availability and cost of acquiring data remain key challenges. As a result, large pharma, biopharma, and CROs plan to increase internal staff dedicated to collection and analysis of real world data by 25% between now and 2020, according to a recent Tufts CSDD survey.
 
This growing volume of data collected in clinical trials is contributing to longer development times and posing technical and integration challenges to clinical data management staff, according to recently completed analysis by Tufts CSDD.

Align Clinical CRO, a recently launched industry technology standards group, is joining forces with CROs to develop open technology standards to help transform clinical trial operations. The organization brings together six leading CROs to help establish open technology standards aimed at simplifying trial execution and improving the productivity and efficiency of clinical trials for sponsors. Members include Syneos Health, ICON, Medpace, Inc., PPD, PRA Health Sciences, UBC and Veeva.
 
Contract Pharma spoke with several members to learn about Align Clinical CRO goals and initiatives, addressing challenges associated with CRO/Sponsor partnerships, outsourcing, and the challenges and delays associated with the growing volume of data in clinical trials. –KB
 
Contract Pharma: Please describe the initiative and its goals.
 
Brett Husselton, senior vice president of commercial strategy at UBC, one of the founding members of Align Clinical CRO: “The purpose of Align Clinical CRO is to create open technology standards that make it easier for life sciences companies and CROs to work together. The initiative is pragmatic in that it is assembling full-service outsourced service providers to accomplish three core goals: 1) align on common friction points within the design, implementation, operational, and ongoing management phase of outsourced research; 2) develop standard data definitions and models that will be endorsed by this deep pool of CROs; and 3) make the standards universally available to enable scale, decrease the time wasted on non-strategic activities.”
 
Henry Levy, president of Align Clinical CRO and chief strategy officer for Veeva Systems: “Our mission is to make it easier for the industry to work together during clinical trials. We’ll do that by solving common pre-competitive industry challenges such as sharing operational metrics about trials data during study execution. There was tremendous energy and momentum among leading CROs to come together and make clinical trials more efficient and productive. Align Clinical CRO signals the commitment of CROs, who run a significant percentage of total trials, to find common solutions that benefit the entire industry and improve drug development processes.”
 
CP: What are the biggest challenges associated with CRO/Sponsor partnerships today and how can they be overcome?
 
Henry Levy of Align Clinical CRO and Veeva Systems: “One of the biggest challenges is that there are different processes and systems across sponsors and CRO partners, making collaboration and real-time decision-making difficult. This will only get more challenging as the ecosystem of stakeholders continues to expand and outsourcing remains a core part of trial strategies. Standards organizations like Align Clinical CRO will make it easier for the industry to adopt common operational processes and technologies. Open technology standards will remove these collaboration barriers and ensure sponsors and CROs can collaborate and execute trials much more efficiently.”
 
Brett Husselton of UBC: “Data exchange is one of the biggest challenges impacting working relationships between CROs and sponsors, which is why Align Clinical CRO is focusing on that as our first standard. Today, there are many different data formats and structures that manufacturers and their partners develop and share. In order to make this data usable, it often requires extensive time and effort from IT teams, business analysts, operations teams and other quality teams involved in testing/release management. In addition, sponsors must take time to load and integrate that operational data about their study into their internal systems and databases. By establishing a common framework for this data that defines its attributes, operational value, and other variables that can travel with that data and be understood across platforms will allow Align Clinical CRO to deliver a market vocabulary and accompanying dictionary. This will save time and resources for all.”
 
Rachel Stahler, chief information officer at Syneos Health, a founding member of Align Clinical CRO: “Align Clinical CRO will help speed the timeline for gaining new therapy approvals for patients. By creating a vehicle for CROs to collaborate and share actionable insight with sponsors, we can improve operational delivery and streamline the increasingly complex trial process for everyone involved.”
 
CP: Are you seeing any new collaboration models with the potential to disrupt traditional outsourcing?
 
Henry Levy of Align Clinical CRO and Veeva Systems: “The goal of Align Clinical CRO is not to disrupt traditional outsourcing but help improve the way CROs and sponsors work together. Outsourcing will continue to rise as a way for sponsors to augment their available resources and leverage the best trial practices from CROs to complete activities faster, with greater efficiency, and more predictable fixed-price costs. Align Clinical CRO brings leading CROs together in a pre-commercial environment to create common, open technology standards that benefit the entire industry and make drug development more efficient and productive.”
 
CP: What is and isn’t working well in partnership models?
 
Henry Levy of Align Clinical CRO and Veeva Systems: “One signal that things are working well is the accelerated innovation and number of trials that continues to rise. We are seeing tremendous innovation, but the time required to bring new medicines to market remains long and the effort to develop them has become increasingly complex, especially as more partners are added to the mix. Information sharing is especially difficult, because of the many different systems and applications used. Open technology standards can help increase sponsor and CRO productivity, reduce operational costs, and run faster trials.”
 
CP: What are the most significant pharma/biopharma R&D trends impacting CROs and services?
 
Henry Levy of Align Clinical CRO and Veeva Systems: “CROs will continue to play a critical role in supporting drug development as sponsors shift to a clinical trial model that allows them to add services with greater specialization, as-needed. We’ll continue to see CROs expand their service offering and become involved in all stages of the R&D process – from drug discovery to regulatory filings. As these full-service CROs find ways to leverage data and insights from trials, manufacturers will turn to them more often as valuable sources for new R&D innovation strategies.”
 
CP: What do you see as the greatest motivators for outsourcing in today’s market?
 
Henry Levy of Align Clinical CRO and Veeva Systems: “Quality, speed and efficiency are the greatest motivators for outsourcing to CROs today. Global, experienced CROs perform hundreds of trials a year, so sponsors can leverage the best trial practices to speed clinical trial execution. Rather than reinvent the wheel with each new trial, sponsors can outsource and leverage lessons learned for better quality studies that are delivered on time and run more efficiently.”
 
Brett Husselton of UBC: “The core drivers for outsourcing are fundamentally the same as they have always been and include the ability to scale quickly, control costs, and fill in with niche or specialized expertise. In other words, speed, cost, and quality – and sponsors want all three from CROs.
 
Additionally, one often understated goal of outsourcing is that procurement is becoming as much about discovery as it is about governing spend and vendor engagement. RFIs and RFPs are becoming more specific – written responses drill deeper, and outsourcing managers are now asking for specific strategic guidance on how to tackle projects most efficiently. In other words, RFPs are often less about service demands and more about asking for an assessment of how to approach a specific need and why this is the best approach. Sponsors are requesting that we share road maps for services, products, and technologies. In this way, we see procurement truly driving discovery and so this becomes another motivator to outsource today.”
 
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?
 
Henry Levy of Align Clinical CRO and Veeva Systems: “CROs and Sponsors are both investing heavily in new capabilities to better integrate and analyze the ever-increasing volume of data that plays a role within and around the execution of clinical trials. Align Clinical CRO is focused on pre-competitive areas where efficiencies can be driven, and therefore, a focus on the operational data exchange, which is a subset of overall data, is a strong fit for our first collaboration across CROs.”