The CenterWatch Monthly (ISSN 1556-3367). Volume 23, Issue 03. © 2016 CenterWatch centerwatch.com

Adopt customized EDC and CTMS while offering own niche solutionsBy Karyn Korieth

T hird-party vendors have come to domi-nate the clinical trial technology sector, which was led by CROs a decade ago.

At the same time, many large CROs continue to invest in technology solutions to differen-tiate their services and offer greater efficien-cies in clinical development processes.

The eClinical solutions market, which includes electronic data capture (EDC) and clinical trial management systems (CTMS), could generate total global sales of $5 billion by 2018, representing a five-year annual growth rate of 13.5%, according to a recent report from global market research company MarketsandMarkets. Yet much of the growth in clinical trial technologies is expected to come from niche providers rather than in-house systems developed by CROs.

Icon Chief Information Officer Tom O’Leary said there has been a “seismic shift” away from internally developed EDC and CTMS systems during the past 15 years. Today, the majority of CROs use commercially developed enterprise applications to support clinical development in phase II and phase III trials. Phase IV and post-marking studies tend to have more unique requirements that are often supported by spe-cialist applications and software systems from CROs and niche providers.

“There is little doubt that a number of niche providers have taken a revenue stream away from CROs when it comes to technolo-gies. There are fewer CROs in the market to-day than there were 15 years ago. The CROs who didn’t have a broad technology and ser-vice offering have been acquired or left the market completely,” said O’Leary.

Yet technology remains a big part of CRO service offerings, particularly as CROs and sponsors feel pressure to contain costs and expedite the clinical trial process. Lead-ing CROs have adapted their businesses to customize commercially available EDC and CTMS application systems and continue to grow and diversify their technology of-ferings. As the market has evolved, large CROs have focused on ways to differentiate their technology systems, work coopera-tively with a range of third-party providers and develop solutions to integrate platforms across companies and trials.

“There is a huge opportunity for smart CROs to do things with technology to dis-tinguish and differentiate their services,”

said Glen de Vries, president and co-founder of Medidata Solutions.

Changing EDC landscape

The industry began implementing EDC, which has become the most widely used clinical trial technology, in the late 1990s af-ter the rise of the Internet allowed for devel-opment of Web-based software that inves-tigative site staff could access with existing computers.

In the early days, CROs worried that EDC technology would cut into core revenue streams by requiring fewer monitors and fewer billable hours. Many developed in-house technologies and systems or acquired small EDC companies to support digitalized data collection. Around the same time, a variety of new and established technology vendors entered the marketplace.

About eight years ago, the eClinical space began to consolidate through more than a dozen deals, including Oracle’s acquisi-tion of Phase Forward in 2010. Technology

CROs juggle proprietary and commercial systems March 2016 A CenterWatch Feature Article Reprint Volume 23, Issue 03

Size of the global EDC market($U.S. in billions)

Source: MarketsandMarkets

2014

$3

2018p 2020p

$4.8

$5.9

2016e

$3.7

e=estimatedp=projected

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companies aimed to offer sponsors a single platform to meet all of their data collec-tion and management needs on a global level. EDC platforms, for example, could be coupled with clinical data management sys-tems (CDMS) or interactive voice response systems (IVRS) as an integrated process. As the market consolidated and evolved, it became increasingly difficult and expensive for CROs to maintain their own in-house systems. Some CROs divested their clinical trial technology offerings.

“The CROs discovered that once they had a system, they needed to be able to maintain it to adjust to a new regulatory environment. It’s a full-time job,” said François Audibert, vice president of Global Consulting in the eHealth Solutions segment at Bioclinica, a specialty clinical trials services provider. “They had to make a decision. Do we want to invest all of that money and effort into this? Or do we want to work with a com-pany that can provide tech as a core offering and concentrate on bringing innovation to our services?”

Today, most major CROs use commer-cially developed EDC and CTMS systems from multiple vendors; some large CROs continue to support internally developed

CTMS systems, but most also use systems developed by third-party vendors in order to accommodate sponsor-company prefer-ences. CRO teams with both IT and clinical trials expertise typically work with vendors to customize the software for particular studies or therapeutic needs.

“Our IT department works hand-in-hand with our business counterparts to ensure the functionality required in the system reflects our market-leading practices,” said Quin-tiles Global Chief Technology Officer Mal-colm Postings. “There is effort required to customize the ‘off-the-shelf’ versions, which is an overhead, but one we balance with ad-ditional services. We always speak with the main IT suppliers to help influence future versions with our requirements.”

Medidata’s de Vries said CRO teams can add value to commercially available plat-forms. Customization work allows them to differentiate their in-house technology sys-tems.

“There are really good technology teams at CROs. They figure out how to integrate what they are getting at scale from a compa-ny like Medidata with things that are going to help them differentiate parts of their busi-ness. Whether it’s figuring out how to look at

2 The CenterWatch Monthly | March 2016 centerwatch.com

IndustryNews

Recent CRO acquisitions of clinical trial technologies

Buyer Acquired company Primary solution(s) Year

Bioclinica Clinverse Automated clinical trial payment firm

2016

PRA Health Sciences

Value Health Solutions

Clinical trial management applications

2015

Icon MediMedia Integrated scientific and market access

2015

PAREXEL ClinIntel Randomization trial and supply management

2014

Bioclinica Blueprint Clinical Risk-based monitoring 2014

Icon AptivSolutions Design and execution of adaptive

2014

Icon Firecrest Site management and performance

2011

Source: CenterWatch analysis of company reports and websites

or enhance the way they deal with analytics or connect it to their other operational sys-tems, the idea is that they are going to build on that core platform,” said de Vries.

Leading companies also invest in technol-ogy segments through acquisitions. This can expand and diversify their service offerings, and support the in-house technology teams that develop and integrate software applica-tions and systems across their service lines.

For example, last year PRA Health Sci-ences acquired clinical development soft-ware company Value Health Solutions to further develop its Predictivv clinical trial management platform. Icon has also made several acquisitions recently to build its technology and service offerings and to differentiate its technology systems. The acquisitions of Firecrest Clinical and Aptiv Solutions provided technologies for patient recruitment and adaptive clinical trials that are different than what other CROs offer. Icon also has teams that develop and inte-grate software applications across all of its service lines, which include platforms for data collection, information resources and technology (IRT) and imaging. But O’Leary said the CRO doesn’t view its technology as a core business.

“Technology enables us to differentiate our services more efficiently, which in turn enables us to help our clients to take time and cost from the development program,” he said.

PAREXEL is unique in that it continues to invest in its technology division, PAREX-EL Informatics, as a core area. The division competes directly with third-party clinical development software vendors. PAREXEL hosts and maintains its own DataLabs EDC, but the company also can build and main-tain third-party EDC software depending on a specific client’s preference. In Decem-ber, PAREXEL launched a new, simplified

version of its CTMS aimed at small-to-midsized biopharmaceutical companies. Its technology platform includes randomiza-tion and trial supply management (RTSM) and medical imaging applications. The CRO integrates the technologies into its research processes and also makes them commer-cially available through a partner program.

David Kiger, vice president, product strat-egy at PAREXEL Informatics, said CRO software teams have unique clinical, regula-tory and commercialization expertise that can lead to innovations in the research and development process. For example, PAR-EXEL created a platform called LIQUENT InSight to manage the entire lifecycle of a regulatory product, from early planning through retirement, as a result of many di-rect conversations with customers about the challenges they encountered in standardiz-ing data to meet legislative requirements.

“Independent software vendors tend to focus on features. As part of a CRO, the PAREXEL Informatics team brings in-dustry domain expertise to the technology solutions,” Kiger said. “With our focus in regulatory services, PAREXEL begins the design and capture of data with the end in mind. Domain expertise is critical for the therapeutic area requirements. For example, how you design electronic collection for a disease such as Lupus can be very different than how you design an obesity study for outcomes/events capture.”

IndustryNews

3 The CenterWatch Monthly | March 2016 centerwatch.com

Notable recent acquisitions by technology solutions providers

Buyer Acquired company Primary solution(s) Year

ERT PHT ePRO and mobile clinical trial applications

2015

Medidata Solutions

Patient Profiles Risk-based monitoring applications

2014

IMS Health Cegedim Customer relationshipsmanagement

2014

ERT InvivoData ePRO 2012

IMS Health DecisionView Study planning and execution 2012

Oracle ClearTrial Resource and capacityplanning

2012

Medidata Solutions

Clincial Force CTMS 2011

Oracle PhaseForward EDC/CTMS 2010

Source: CenterWatch analysis of company reports and websites

Leading CROs with internally developed CTMS systems

Leading CRO (in alphabetical order) System

Covance Xcellerate

Icon Iconik

Medpace ClinTrak

PAREXEL Impact

PPD Preclarus

PRA Health Sciences Predictivv

Quintiles Infosario

Source: CenterWatch analysis of company reports and websites

A new direction

The shift away from internally developed EDC systems has forced major CROs to re-think their business strategies and evaluate how technologies can best be used to im-prove clinical trial processes going forward.

“We needed new thinking to take that ex-tra step into the 2020 world, which is where we are heading pretty quickly, and define a future roadmap,” said Quintiles’ Postings, an IT and business strategy expert who joined Quintiles last year. “How do you have wider connections to multiple data sources? How do you offer insight as a service? How do we use our data scientists to really look at biomarkers and amazing amounts of de-tail?”

Quintiles has a suite of integrated data systems and services under the Infosario brand, which includes CTMS, clinical trial design, safety, an investigative site portal, analytics and regulatory information man-agement technologies. As it moves forward, an important component of the IT strategy involves forming partnerships with technol-ogy companies—both large and small—to develop products and services that can ad-dress critical issues such as integrating sys-tems across companies and trials, improv-ing analytics and reporting, connecting information through data hubs or aggregat-ing data from wearable sensors.

“It’s a mixture of the software, which is IT-focused, blended with our knowledge,” said Postings. “We are not developing software to sell software. But it’s a core component of everything we do and it’s going to become more and more important.”

One of the future challenges for CROs is keeping ahead of new technology devel-opments in the marketplace. Not only is

there a profusion of new systems flooding the market, such as CTMS, electronic trial master files (eTMF) and regulatory informa-tion management (RIM), new clinical trial platforms increasingly require a mobile ser-vice component and mobile interface. The market also is moving toward technologies developed by more niche expert providers in smaller areas.

Postings said Quintiles is focusing its in-tegration efforts across four domains: busi-ness process management and workflow; event management; API gateway; and sys-tems/applications integration.

“There is a convergence of systems and technologies taking place and a greater de-mand for a more seamless and integrated solutions with single sign-on capabilities,” said O’Leary. “CROs who have learned to collaborate and integrate their capabilities and processes with third-party providers are the CROs who will continue to succeed in the future.”

Looking ahead

Third-party vendors are expected to in-crease their market share in the clinical trial technology sector going forward; companies are continuing to make acquisitions that ex-

pand their technology offerings and can be integrated into existing platforms or busi-ness segments. Bioclinica’s recent acquisi-tion of Clinverse, for example, adds clinical trial payment services to its offerings, while Medidata recently boosted its risk-based monitoring software through the acquisi-tion of Patient Profiles.

CROs, however, can continue to operate successfully in this space if they can adapt their technology businesses, diversify their offerings and differentiate themselves in the marketplace.

“Technology now is creating new ways of performing monitoring, new ways of look-ing at decision-making through therapeutic experts and new business-process tools. The world is changing and it’s changing for the better. But you have to get on the train and ride with it. You can’t really afford to be left behind,” said Quintiles’ Postings.

Karyn Korieth has been covering the clini-cal trials industry for CenterWatch since 2003. Her 30-year journalism career includes work in local news, the healthcare indus-try and national magazines. Karyn holds a Master of Science degree from the Columbia University Graduate School of Journalism. Email karyn.korieth@centerwatch.com.

IndustryNews

4 The CenterWatch Monthly | March 2016 centerwatch.com

Primary EDC platforms used by select CROs

Leading CRO (in alphabetical order)

Icon Medidata Solutions, Oracle, sponsor systems, Datatrak for phase IV studies

PAREXEL PAREXEL Informatics DataLabs EDC

PPD Medidata Solutions, Oracle, OmniComm Systems

Quintiles Oracle, Medidata Solutions

Source: CenterWatch analysis of company reports and websites