The Necessity of Open Technology Standards to Create a Connected Clinical Network

Clinical Researcher—June 2019 (Volume 33, Issue 6)


Julie Ross


The life sciences industry is experiencing tremendous innovation, bringing drugs to market at an accelerated pace. In 2018, the industry achieved a record-setting number of 59 drug approvals.{1} These new drugs offer tremendous hope, but the costs to develop new and complex therapies are significantly escalating. The average cost of Phase II clinical trials ranges from $7 to $19.6 million, while costs for a Phase III clinical trial can escalate as high as $52.9 million.{2}

Long timelines associated with clinical trials contribute to study delays and expense. Even as sponsors outsource clinical trial activities to contract research organizations (CROs) to gain efficiencies, disparate technology and a lack of data uniformity can increase the time and costs required to bring new medicines to market. Information sharing becomes especially difficult, because of the many different systems and data definitions used by stakeholders in disparate locations.

A connected clinical network supported by open technology standards can help increase sponsor and CRO productivity, reduce operational costs, eliminate duplicate work, and run trials faster. A clinical network can also address many of the collaboration and technology challenges that exist in today’s clinical environment.

Common Challenges with Information Sharing and Clinical Collaboration

Clinical outsourcing is not only increasing in volume, but also in breadth as sponsors are now using CROs to manage nearly all phases of drug development, including preclinical research, clinical testing, and post-approval functions such as safety assessment, monitoring, commercialization, and consulting.{3} By 2020, sponsors are expected to outsource 72% of clinical trials to CROs,{4} and many will contract the specialized services of multiple CROs for one clinical trial to manage different functions, further complicating collaboration.

Different disconnected technologies used by CROs to support the essential components of their part of clinical trials often create barriers in communication and data exchange—especially when involving multiple CROs. ISR recently surveyed decision-makers across all phases of clinical development and found more than half (56%) of sponsors would switch providers for a CRO offering improved clinical technology integration.{5}

“The relationship between a CRO and a sponsor is contractual at its base level. However, it’s really about people communicating with each other and information flow between those key clinical stakeholders,” explained Henry Levy, general manager of Veeva Vault CDMS and president of Align Clinical CRO. “Today, no standard mechanism exists for data and document sharing.”

For example, a life science company may contract one CRO for patient recruitment and monitoring, and another for data management. Each CRO is using different systems to manage the information that is valuable to all stakeholders. Often CROs must also interact with each other as well as the sponsor. In this type of environment, collaborative and fluent data exchange are key among different stakeholders, but can be stymied by the use of different technologies and processes. Information is exchanged via e-mail, which often requires manual reentry into different systems—a process prone to introducing errors. Lack of visibility into operations, too, requires that sponsors conduct repetitive audits to ensure information is correct, as pharmaceutical companies are ultimately responsible for the clinical trial.

Standards Can Break Down System and Process Silos

In many cases, sponsors and their CRO partners use their own environments to automate the management of site contract information, clinical data management, and clinical trial records maintenance. Replacing disconnected and outdated systems with an interoperable system breaks down data silos while driving more efficient processes for all stakeholders through the different stages of the clinical trial processes. Common standards that define data formats and definitions can dramatically improve data exchange between systems.

For example, documents in the CRO’s electronic trial master file (eTMF) system must also exist in the sponsor’s eTMF system identically, but there are often version control challenges and redundancy leading to lost productivity. The CRO must load documents into its eTMF and then send duplicate documents to the sponsor who loads them into its eTMF.

The DIA TMF Reference Model has created standards for more effective mapping of documents across stakeholders in this area. Additionally, there are opportunities to introduce common standards to address challenges in other clinical data management areas. In a connected clinical network with standards for information exchange, document uploading can happen in real time and eliminate much of the duplicate effort that occurs today.

Standard Definitions and Vocabulary Have Big Benefits

“Every time any combination of the approximately 5,000 sponsors and 200 CROs that exist today shares data on a clinical trial, they have to agree what data will flow and the exact definition of that data. It’s complicated, and doesn’t always work well,” noted Levy.

Definitions are critical. For instance, a CRO and sponsor may define “first patient in (FPI)” differently. Is FPI defined by the first patient randomized into the study, or is it based on when the first patient was dosed? To achieve clarity, both parties must go back and forth negotiating definitions for all of the data fields and customize a file. “This takes time and is not always a perfect science,” added Levy.

Next, the sponsor takes that file to its information technology department to manipulate it so data can flow into the clinical trial management system. Often, the upload doesn’t work, or is too time-consuming or burdensome, so the CRO and sponsor resort to using spreadsheets and dashboards. The process is further complicated as most sponsors use multiple CROs rather than just one for a single study. For one large study, a sponsor might use 10 CROs and have hundreds of exchanges.

A standard vocabulary will allow stakeholders to speak the same language to create a universal source of truth. Labeled, formatted, and defined the same way in every study, datasets can have the same semantic meaning across different trials. One key to ensuring semantic interoperability is for stakeholders to use the same standards—the more parties who agree on them, the better.

With data structured identically in every study, sponsors and CROs could analyze aggregated data with powerful artificial intelligence tools to uncover rich insights and trends. By analyzing the results of multiple studies, sponsors can better predict a particular outcome to get closer to results faster. Companies also save time by re-using resources instead of reinventing the wheel with each trial. Data reuse also can help CROs when bidding on prospective new studies by basing costs and activities on past experiences. In turn, CROs can offer more attractive options to sponsors for saving time and resources.

New Group Focused on Creating Industry Standards

Understanding the value of a common language when using technology during clinical trials, leading CROs formed Align Clinical CRO last year to create open technology standards to improve trial execution and collaboration with sponsors. Align Clinical CRO now includes Advanced Clinical, ICON plc, PPD, Medpace, Inc, PRA Health Sciences, Syneos Health, and UBC.

Working with the life sciences technology provider Veeva Systems, and with input from the industry at large, Align Clinical CRO is developing open technology standards to help streamline information sharing during trials and give sponsors greater visibility into study execution when working with CROs. With standards, both parties can learn to improve efficiencies study-over-study in the same class of drugs by identifying and mitigating risks more quickly and learning from published data. Further, with established standards, more sponsors and CROs will leverage new technologies to drive greater efficiencies.

The first standard proposed by Align Clinical CRO addresses common challenges with sharing operational metrics about trials data during study executive. This Operational Data Exchange standard will define the data and structure for a consistent and easy exchange of metrics and milestone information for areas such as general trial details, study start-up, patient enrollment, and data management. The standard will improve the exchange of information between sponsors and CROs during Phases II and III of clinical trials, and will provide technical considerations when developing application programming interfaces for clinical trial systems. The group will make the final standard available this year.

“Open technology standards can transform clinical trials to be more productive, reduce operational costs, and speed execution across the industry,” said Levy. “Align Clinical CRO is committed to improving CRO collaboration with life sciences companies and reducing the time and effort needed to bring innovative therapies to patients.”

Standards Will be the Foundation for a Connected Clinical Network

A connected clinical network is key to automate data and document flow among sponsors, CROs, sites, and even regulators for better and faster collaboration. Open technology standards are imperative to enable content and data exchange among different stakeholder systems without manual methods.

Through the creation of standards proposed by Align Clinical CRO and those already enacted by other groups, including CDISC (Clinical Data Interchange Standards Consortium) and the DIA, the concept of a connected clinical network can become a reality by guiding stakeholders to work by a common set of rules to collect and structure data that serve everyone.

“Open technology standards will transform clinical trials to be more productive, reduce operational costs, and speed execution across the industry,” concluded Levy. “Standards can help create a new world in which research data can be shared and aggregated seamlessly to accelerate collaborative learning and streamline the path to new therapies.”


  1. U.S. Food and Drug Administration. 2018 New Drug Therapy Approvals. See the full article here.
  2. The Pharma Letter. $1-$13 million a day at risk from product launch delays. May 2014. See the full article here.
  3. Results Healthcare. M&A trends in the CRO industry. March 2019. See the full article here.
  4. Business Wire. Research and Markets: The New 2015 Trends of Global Clinical Development Outsourcing Market. January 2015. Read the full article here.
  5. Life Science Leader. Are Outsourcers Interested in Changing Their CRO Mix? ISR Reports, April 2019. See the infographic here.

Julie Ross
( is President of Advanced Clinical, a clinical development organization participating in the Align Clinical CRO industry standards group. She has more than 25 years of clinical research experience.