February 2015, IDC #254210

Industry Developments and Models

IDC TechScape: Worldwide Life Science Clinical Trials Technologies, 2015

Alan S. Louie, Ph.D.

IDC OPINION

FIGURE 1

IDC TechScape: Worldwide Life Science Clinical Trials Technologies, 2015

Note: This IDC TechScape chart is representational of various technology adoption life cycles, given IDC's current analysis of the

market. It is not a detailed or dynamic mathematical model. There is no preestablished time frame for the various adoption curves.

Source: IDC, 2015

Figure 1 shows the 2015 IDC TechScape worldwide life science clinical trials technologies.

©2015 IDC #254210 2

Technology is an integral component in the life science industry overall and especially within the

discovery research and clinical development spaces. As life science companies seek to rapidly

innovate in response to industry pressures, technology will play an increasingly important role through

both enabling and more directly supporting key industry processes integral to the complex, highly

regulated product discovery and development life cycle. In addition, new data, information, and

knowledge resources are becoming available that must be integrated into current best practices.

Technological innovation is expected to strongly contribute to the next-generation best practices

approaches that will lead the industry into the future. This IDC TechScape study focuses on

technology adoption within the life science clinical development space. It assesses key technologies

that are driving evolution beyond industry technology best practices in place today. Besides looking

more deeply into individual technologies, this document considers technology-specific analyst insights

regarding anticipated rate of adoption, potential risks impacting future success, and industry market

interest. The IDC TechScape model is designed specifically to capture progress in the adoption of

emerging disruptive technologies, mainstream technology buyer alignment with current industry best

practices, and supporting technologies that promise to deliver operational advantages to organizations

that choose to adopt them. IDC expects that life science executives will use the IDC TechScape model

to:

Assess the progress of their own technology adoption efforts in comparison with the industry

overall

Identify new technologies that should be added to consideration in their technology road map

Add new insights to increase the robustness of their own technology decision frameworks

©2015 IDC #254210 3

IN THIS STUDY

The life science R&D technologies IDC TechScape is intended to help senior executives assess their

organizations' technology landscape to determine whether their efforts are aligned with analyst's

assessment of the industry's overall technology adoption progress. While it is clear that an individual

company's tolerance for risk plays a significant role in determining its path forward, this study helps

organizations more systematically categorize and assess relevant clinical trials technologies, taking

into account adoption criteria specific to each technology.

SITUATION OVERVIEW

The life science industry is actively undergoing transformational change as it seeks to regain long-term

sustainability in the shadow of blockbuster drug revenue losses due to the patent cliff. With savings

from the elimination of excess capacity and the externalization of noncore competencies largely

complete, leading industry innovators are increasingly looking beyond their own traditional boundaries

to best practices from outside of the industry. While life science companies are historically averse to

exploring innovation from outside of the industry, the increased urgency dictated by both anticipated

and realized revenue losses has forced them to pursue opportunities to more quickly and efficiently

implement change. While still relatively slow in adoption when compared with other industries, the life

science industry has realized that there is significant potential for advances built on industry-specific

innovation and industry-agnostic innovations proven elsewhere.

Discovery research and clinical development in the life sciences are strongly supported by technology

and technological innovation. With continuing evolution in the industry, including a data explosion

fueled by the $1,000 genome and increasing access to healthcare and consumer data, the growing

need to routinely process ever-larger amounts of information and knowledge on a global basis, and an

ever-expanding global collaborative work environment, effective adoption of appropriate technologies

is the likely sole path to systematically and efficiently move companies forward.

Unlike other technology assessment frameworks, the IDC TechScape is intended to provide a visual

representation of the process of technology adoption, dividing technologies into three major categories

based on their impact on the organization and then assessing their relative maturity within their

respective categories. In addition, in reviewing specific, individual categories, additional insights

regarding the speed of adoption, technology potential for success (risk), and industry market buzz are

also considered (refer back to Figure 1).

The IDC TechScape

This IDC TechScape study focuses on different technologies used to support the clinical trials needed

to validate a potential new drug's safety and efficacy. Ranging from infrastructure technologies

supporting eClinical platforms to technologies that promise to improve operational efficiencies to

technologies that will bring new forms of patient data to trials, this IDC TechScape captures the full

spectrum of technology types that will impact the industry both now and in the future.

©2015 IDC #254210 4

This IDC TechScape provides technology buyers with a snapshot of technologies and their current

state of adoption in the life science clinical development space. Recognizing that the rate of

technology adoption can vary with organizational risk tolerance, the IDC TechScape is intended to

represent adoption progress expected for mainstream technology adopters.

The IDC TechScape is composed of three separate adoption profiles, representing technologies

supporting disruptive processes (transformational), current technology best practices (incremental),

and supportive technologies that can deliver improved operational effectiveness or efficiencies

(opportunistic).

Within each adoption profile, individual technologies are positioned relative to their adoption maturity.

IDC has identified five basic stages to technology adoption: evaluate, test, deploy, maintain, and

replace. Refer back to Figure 1, which displays the adoption curves and the relative stages of adoption

for each technology on the IDC TechScape graph.

Scope and Domain of the IDC TechScape

The core foundation of an IDC TechScape is the definition of the specific technology coverage area

within its specific use domain. The IDC TechScape is intended to provide IT and technology buyers

with a current snapshot of the user domain, which may be specific to a particular focus area or

industry. As a result, it becomes possible for specific technologies to be positioned in different places

on the IDC TechScape, depending on what user domain is being discussed. For example, while public

clouds are positioned in the deploy stage within the opportunistic category in this IDC TechScape, they

would likely be considered to be in the maintain stage within the incremental category in an IDC

TechScape focused on industry-agnostic datacenter technologies. As a result, an understanding of the

specific domain associated with an IDC TechScape figure is critical to applying the market insights

contained within.

IDC TechScape Categories and Definitions

The categories that define the three types of adoption curves in an IDC TechScape are (see Table 1):

Transformational: The transformational category includes disruptive technologies that are likely to be next generational by their potential to fundamentally transform current industry best

practices. While clearly different from current best practices, technologies that are successful in this category are likely to represent the best practice technologies of the future.

Covered technologies/processes: Adaptive trials, virtual trials, gamification, risk-based monitoring (RBM) trials, cognitive computing, mobile-linked diagnostics, and Webcam

diagnostics

Incremental: The incremental change category includes technologies that represent current

industry best practices. While different technologies can clearly be at different stages of adoption, these technologies are generally recognized as best practices currently in use in

clinical trials, with the analyst's assessment of average industry adoption for each technology represented. These technologies are expected to continue to incrementally evolve over time.

©2015 IDC #254210 5

Covered technologies/processes: Electronic data capture (EDC), eClinical solutions, electronic trial master file (eTMF), translational research, crowdsourcing, real-world

evidence (RWE) trials, and drug portfolio trials

Opportunistic: The opportunistic category includes those technologies that contribute to

industry progress but are not considered integral to current best practices. These technologies may include industry-agnostic solutions that help advance efforts but are not critical to

success. While not absolutely required, technologies in this category contribute to company success through more streamlined process execution, direct cost savings, and improved process outcomes.

Covered technologies/processes: Private clouds, BI platforms, public clouds, social media

engagement, and big data platforms

TABLE 1

IDC TechScape Technology Markers of Momentum

Curve Type Technology Stage of Adoption Speed of Adoption Risk Level Market Buzz

Transformational Adaptive trials Deploy Medium Low Medium

Virtual trials Test-deploy Medium Medium High

Gamification Test Medium Medium Medium

RBM trials Test Fast Low High

Cognitive computing Evaluate-test Slow Medium High

Mobile-linked diagnostics Evaluate Medium Low Medium

Webcam diagnostics Evaluate Slow Medium Low

Incremental EDC Maintain Medium Low Low

eClinical solutions Deploy Fast Low Medium

eTMF Test-deploy Medium Medium High

Translational research Test-deploy Medium Medium High

Crowdsourcing Test Slow Medium Medium

RWE trials Evaluate-test Slow Medium Medium

Portfolio trials Evaluate Slow High Low

©2015 IDC #254210 6

TABLE 1

IDC TechScape Technology Markers of Momentum

Curve Type Technology Stage of Adoption Speed of Adoption Risk Level Market Buzz

Opportunistic Private clouds Maintain Medium Low Medium

BI platforms Deploy-maintain Fast Medium High

Public clouds Deploy Fast Medium High

Social media

engagement

Test Slow High High

Big data platforms Evaluate-test Medium Medium Medium

Technology = Technologies supporting clinical trials in the life sciences

Stage of Adoption = Progress relative to the five stages of technology adoption (evaluate, test, deploy, maintain, or replace)

Speed of Adoption = How quickly technology adoption is moving (fast, medium, or slow)

Risk Level = The potential level of risk impacting success in technology adoption (high, medium, or low)

Market Buzz = The level of industry enthusiasm regarding the promise of a particular technology (high, medium, or low)

Source: IDC, 2015

IDC TechScape Technology Descriptions

In conjunction with each life science technology or process description, each IDC TechScape

technology includes an IDC TechScape Spotlight that is intended to provide additional analyst insights

regarding the expected momentum that a particular technology is expected to carry with it. The IDC

TechScape Spotlight is composed of three independent, analyst-determined metrics — speed, risk, and

market buzz:

Speed: How quickly technology adoption is moving (fast, medium, or slow)

Risk: The potential level of risk impacting success in technology adoption (high, medium, or

low)

Buzz: The level of industry excitement regarding the promise of a particular technology (high,

medium, or low)

©2015 IDC #254210 7

Adaptive Clinical Trials

FIGURE 2

Adaptive Clinical Trials Markers of Momentum

Source: IDC, 2015

Clinical trials that are built and performed using adaptive designs are intended to allow trial managers

to dynamically change trial conduct at any stage during an ongoing trial based on the predetermined

response to specific performance criteria. Early termination of nonresponsive trial arms and early

validation of primary endpoints are examples of adaptive trial designs. Adaptive clinical trials are

intended to allow clinical trial managers to more efficiently manage trial resources while concurrently

accelerating time to outcomes.

Virtual Clinical Trials

FIGURE 3

Virtual Clinical Trials Markers of Momentum

Source: IDC, 2015

First performed in 2011 by Pfizer in its REMOTE trial, the application of a number of technology

innovations to enable and empower a "siteless" clinical trial (i.e., participating trial patients do not need

to go to a physical trial investigator office but visit specified locally available physicians or medical

laboratories as needed) demonstrated the potential of a virtual clinical trial, despite not achieving its

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desired trial outcome. The ability to access a much larger potential trial participant pool while

maintaining required patient safety and regulatory compliance requirements is potentially a

transformative innovation that should enable increased access to a much broader potential trial

candidate population, faster overall trial enrollment, and more streamlined trial execution (allowing

trials to start earlier and finish faster). With only limited experience in the field, virtual clinical trials carry

significant unknown risk factors that limit rapid mainstream adoption at this time.

Gamification

FIGURE 4

Gamification Trials Markers of Momentum

Source: IDC, 2015

The use of gamification technology in clinical development aspires to improve stakeholder (i.e.,

patient, investigator, and clinical staff) engagement, satisfaction, and compliance using approaches

that have delivered proven results in other industry and social venues. With performance data already

captured as part of ongoing clinical data collection, it should be possible and reasonably simple to

apply game thinking and mechanics to areas that include trial patient recruitment, patient compliance,

and investigator management. As an innovation approach that seeks to leverage human nature

without adding significant new costs, the use of gamification in clinical development is primarily limited

by creativity in execution and the need to operate in a tightly regulated ecosystem.

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Risk-Based Monitoring Clinical Trials

FIGURE 5

Risk-Based Monitoring Clinical Trials Markers of Momentum

Source: IDC, 2015

With strongly supportive guidance from global regulatory bodies over the past three years, the industry

has been aggressively developing risk-based monitoring approaches to the execution of new clinical

trials. The prospect of more efficient, higher-quality, and, likely, lower-cost clinical trials is the core

benefit of the RBM approach, and sponsor companies, along with their execution partners, are

transitioning their clinical strategies and processes to accommodate this new approach. As with most

complex processes, clinical trials have a large number of core elements, key tasks, process controls,

regulatory requirements, people, and places that will need to be systematically transitioned to this new

approach while concurrently maintaining traditional efforts for trials initiated prior to the advent of RBM.

With roles expected to change with RBM, proper training and clear strategic guidance will be key to

success.

Cognitive Computing

FIGURE 6

Cognitive Computing Markers of Momentum

Source: IDC, 2015

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From a practical perspective, most people will likely view cognitive computing technology solutions as

processes that utilize IBM's Watson computer system. As a platform designed to apply an artificial

intelligence approach to complex problem solving, Watson is capable of analyzing very large amounts

of data to extract relationships and correlations relevant to a particular problem. From a clinical

development perspective, Watson can systematically examine all available data, information, and

knowledge related to a drug or medical issue and bring forth this data to potentially provide fresh

insights to ongoing industry problems. Watson has applications across the industry spectrum, ranging

from providing comprehensive literature reviews regarding a specific researcher project to identifying

potential opportunities to repurpose drugs to screening for potential new drug safety indicators, and

more. While early in its commercialization, Watson is expected to find significant utility in the life

sciences as pilot efforts begin to demonstrate value.

Mobile-Linked Diagnostics

FIGURE 7

Mobile-Linked Diagnostics Markers of Momentum

Source: IDC, 2015

As a technology that is experiencing early adoption within the healthcare-based remote patient

monitoring market, mobile-linked diagnostic technologies offer significant potential to improve the

clinical trials process through more real-time, remote access to clinical trial patient data as it is

generated. Using wireless sensors in conjunction with patient smartphones, it becomes possible to

actively monitor patient metrics without the need for patients to intervene. With several FDA-approved

mobile-linked diagnostic solutions available and many more in development, this new technological

capability promises to provide more specific data to trial investigators in real time while concurrently

enabling better patient safety through earlier identification of potential adverse events.

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Webcam Diagnostics

FIGURE 8

Webcam Diagnostics Markers of Momentum

Source: IDC, 2015

While historically used in monitoring consumer behavior for marketing purposes (e.g., tracking eye

movement in response to television commercials), the potential use of patient Webcams to monitor

and measure their capabilities and performance offers new opportunities to measure disease and/or

treatment progress. Especially relevant in areas such as CNS and potentially in conjunction with

gamification technologies, Webcam-based diagnostics offer the potential to regularly measure patient

physical responses that may be associated with disease progression. With specific Webcam-based

biomarkers still in early research stages, this application remains likely on the longer-term horizon,

although the technologies are sufficiently advanced to enable applications over the near term.

Electronic Data Capture

FIGURE 9

Electronic Data Capture Markers of Momentum

Source: IDC, 2015

EDC has been the core element in the transition from paper-based to electronically data-captured

clinical trials. IDC believes that while most of the later-stage addressable EDC market has been fully

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penetrated, some additional growth remains (primarily in Phase I and Phase IV trials and through

expanded use in the broader eClinical space) in this mature technology space.

eClinical Solutions

FIGURE 10

eClinical Solutions Markers of Momentum

Source: IDC, 2015

With the emergence of electronic alternatives to each of the processes associated with the conduct of

a clinical trial, it became possible to connect these processes to form more comprehensive eClinical

trial platforms. The ability of eClinical platforms to share data across individual processes adds

significant process efficiencies and enables earlier insights into potential drug safety issues. In

addition, with the increasing use of contract research organization (CRO) services to execute clinical

trials, preconfigured, prepackaged eClinical solution offerings are becoming more practical, especially

in the case of small- to midtier sponsors that fully rely on service providers for their trials. While best-

of-breed eClinical platform components remain a concern for specific needs or specific sponsors (e.g.,

the use of Oracle InForm or Medidata Rave EDC platforms for pivotal late-stage trials), easy-to-use,

interconnected, cost-effective, and comprehensive eClinical platforms are experiencing increased

interest as sponsor companies focus on outcomes over process.

Electronic Trial Master File

FIGURE 11

eTMF Markers of Momentum

Source: IDC, 2015

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The electronic trial master file is intended to electronically manage all trial documentation, images, and

other digital content to maintain regulatory compliance and respond to interactions with regulators.

Historically, trial master files have been paper based, requiring significant dedicated effort in response

to regulatory events (e.g., new drug filings or regulatory audits). With evolving regulatory guidelines

supporting the increased use of eTMF and other electronic content management solutions to achieve

higher levels of regulatory compliance and reduce business risk, the industry is actively transitioning

away from paper. While efforts are ongoing to standardize the eTMF requirements across the industry,

commercial eTMF solutions vary significantly and a number of different platforms are in use today.

Translational Research

FIGURE 12

Translational Research Markers of Momentum

Source: IDC, 2015

While not a specific technological innovation per se, translational research is a paradigm-changing

approach to life science research that will exploit a wide variety of technological innovations in its

execution. Translational research seeks to use data from across the life science and healthcare

ecosystems to better inform strategic decision making. As an example, by bringing in disease-specific

data from patients in a healthcare setting, it should be possible to determine whether an early-stage

disease model accurately reflects disease manifestation in humans. Exclusion of approaches whose

data are not supported reduces wasted effort that has significantly reduced the likelihood of success

and allows for resources to be better allocated. In lowering risk and increasing the likelihood of

success for efforts across the life science product life cycle, translational research promises to improve

the operational effectiveness and efficiency of the industry overall.

©2015 IDC #254210 14

Crowdsourcing

FIGURE 13

Crowdsourcing Markers of Momentum

Source: IDC, 2015

Enabled by the emergence of social media technology platforms in the consumer space,

crowdsourcing offers significant potential for a new source of funding for early-stage life science

ventures. Whether supporting early demonstration projects in discovery research or potentially

paradigm-changing approaches to clinical trial recruitment or patient compliance, crowdsourcing is a

quickly accessible resource that allows for unconventional ideas to advance. While not a substitution

for the major financial commitments required to advance promising drugs through clinical

development, this alternative financial vehicle may have a role to play in the industry as a grassroots

alternative to angel investors.

Real-World Evidence Trials

FIGURE 14

Real-World Evidence Trials Markers of Momentum

Source: IDC, 2015

While regulatory requirements necessitate the validation of drug performance separate from

complicating factors (e.g., concurrent disease management), patients in the real world (and especially

aging patients in the developed world) routinely are managing multiple medical conditions at the same

©2015 IDC #254210 15

time. For most drugs, effectiveness and safety have not been tested for concurrent unrelated drugs

being used together (unless there are obvious recognized drug interactions). While immediate and

near-term adverse drug interactions become readily apparent once drugs become commercially

available, longer-term adverse reactions are often not identified, resulting in increased negative

outcomes in the population at large that could be averted (e.g., increased potential for a cardiac event

or greater sensitivity to other diseases). With more post-approval REMS trials ongoing and the use of

advanced social media analytics, it is becoming possible to better assess drug performance in real-

world situations. While not necessarily the purview of drug companies, this research will be

increasingly enabled by big data and analytics, clinical data accessible via data transparency

initiatives, and social media data.

Portfolio Trials

FIGURE 15

Portfolio Trials Markers of Momentum

Source: IDC, 2015

As we increasingly understand disease at the molecular level, it is becoming possible to develop drugs

that specifically target disease factors specific to the individual. For many diseases, this may mean that

a portfolio of potential drugs can be identified that take into account individual disease factors

(biomarkers) that can be used to determine which drug candidate is most likely to be effective in that

individual. For complex diseases and diseases with recognized variants, this may be the best

approach possible to manage the disease overall, allowing for the approval of a portfolio of effective

drugs capable of addressing most, if not all, of the patients afflicted with the disease in a timely

fashion. While currently being performed on a piecemeal basis, a portfolio approach may be applicable

for next-generation drugs that are being applied to diseases where our growing knowledge uncovers

variations important to disease treatment. At present, however, there is no regulatory pathway to

approving this approach, a concern that will strongly slow progress in approving portfolios of drugs

over the near- to midterm.

©2015 IDC #254210 16

Private Clouds

FIGURE 16

Private Clouds Markers of Momentum

Source: IDC, 2015

As a more physically secure approach to cloud adoption (compared with public clouds), private clouds

are a technological innovation that helps extend internal IT infrastructure without raising significant

concerns over data security. While more costly, the highly risk-averse life science industry has

embraced this transitional approach to cloud adoption based on both direct cost savings and increased

agility in extending the enterprise. The life science industry continues to lag behind other industries in

the rate of cloud adoption but is slowly making the shift as access, reliability, security, and regulatory

concerns are allayed. IDC expects that the use of private clouds will grow over the near term but

diminish somewhat over the longer term as capacity shifts to more cost-effective public clouds for

noncritical efforts.

BI Platforms and Technologies

FIGURE 17

BI Platforms and Technologies Markers of Momentum

Source: IDC, 2015

As part of current efforts by the industry to transform itself, the ability to translate data into actionable

information has maintained a high priority within life science organizations. Efforts to embed analytics

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into operational platforms, expand BI across the enterprise, and bring together data from disparate

data silos within the organization are beginning to pay off, and efforts have further expanded with

access to new data resources including EMR data, healthcare payer data, and consumer social media

data. With improved access to organizational data, companies are now implementing automated

workflows capturing current industry best practices to deliver alerts to key stakeholders that can act on

the data to drive both strategic and tactical decision making. The increasing BI challenge for

organizations will be keeping up with growing data volumes, maintaining regulatory compliance with

restricted data sets, and ensuring that analytics deliver accurate insights from evolving data resources.

Public Clouds

FIGURE 18

Public Clouds Markers of Momentum

Source: IDC, 2015

While agility and cost savings remain the key benefits of shifting from on-premise and private cloud

platforms to public clouds, the primary concern with the use of public clouds continues to be in the

area of data security. In the especially risk-averse life science industry, this has greatly slowed the

adoption of public clouds in all regulated areas (e.g., clinical trials) while concurrently allowing the

largely unregulated discovery research area to quickly shift into the space. As additional security

measures are being put in place and industry fears begin to be put aside, there is an ongoing shift

toward public over private clouds. At the same time, increased externalization of the life science

enterprise is opening up new opportunities to use public clouds as the common workspace for

collaborative efforts. IDC expects the use of public clouds to continue to expand in the industry with the

limited exception of highly sensitive areas, taking capacity and costs from existing private cloud and

internal datacenter investments.

©2015 IDC #254210 18

Social Media Engagement

FIGURE 19

Social Media Engagement Markers of Momentum

Source: IDC, 2015

The use of social media by the life science industry has been greatly slowed by concerns over

potential liabilities associated with maintaining regulatory compliance. Issues as to whether companies

are responsible for reporting drug safety events posted to social media sites and potentially illegal

promotion of drugs for unapproved uses have greatly limited the industry's ability to contribute to social

media discussions to date, and regulatory agencies have only provided limited guidance as to what

companies can do. While initial investments have focused strongly on social listening in support of

brand sentiment and competitive intelligence, social media offers significant potential for the industry to

better engage with all key stakeholders, improve compliance for patients taking drugs, and accelerate

patient recruitment in clinical trials. As a technology innovation that remains early in industry adoption,

this area is expected to play a large part in the future of the industry, with most efforts yet to come.

Big Data Platforms

FIGURE 20

Big Data Platforms Markers of Momentum

Source: IDC, 2015

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For the most part, the problem of big data in the life science industry has not yet arrived, with a notable

few exceptions (e.g., ELN data management at Merck). With multiple new data resources on the near-

term horizon (e.g., genomics, EMR, social media, and payer data), the industry has recognized that it

needs to manage the big data issue proactively. With the recognition that technological advances will

likely be insufficient to deal with the rate of data growth, companies are beginning to seek ways to

mitigate big data concerns at their sources, with the hope of reducing the amount of data that needs to

be captured and shared. While it remains to be seen how successful organizations will be in managing

the anticipated big data tsunami, the industry is hopeful that big data will not become a significant

problem in the future.

FUTURE OUTLOOK

While not the simple cure for the life science industry's ills, disruptive technological innovation will be a

strong contributor and enabler of progress in the life sciences over both the near- and long term. In our

view, near-term benefits of technology innovations are mostly focused on operational performance

optimization. IDC expects that over the longer term, the impact of technology and IT will be much

greater and deeper, resulting, in some cases, in fundamental changes to current industry business

models.

Recognizing the complex nature of life science R&D and the ability of technology solutions to deliver

additional value outside of their core applications, this IDC TechScape has focused on the broad

spectrum of technology and IT innovations with a goal of highlighting both the near-term impact and

the longer-term implications of specific technology adoption. The IDC TechScape graphic is expected

to change over time, with individual technologies advancing in adoption and potentially shifting curves

as technologies currently categorized as "transformational" go mainstream and become the new

"incremental" best practices (refer back to Figure 1).

ESSENTIAL GUIDANCE

As it considers the technology and IT consumer perspectives, this IDC TechScape provides a

technology reference snapshot that enables life science technology and IT buyers to quickly assess

how their technology adoption compares with the industry overall while concurrently enabling them to

identify and investigate relevant technologies that should be on their radar today.

Domain-Specific Guidance

Top Pharmaceutical Companies

With hundreds, if not thousands, of clinical trials at all stages of progress, top pharmaceutical

companies also carry forth legacy clinical trial applications that are likely only now transitioning toward

a more unified and streamlined approach to trial execution. In addition, these companies have

significant organizationwide IT infrastructure that is also transitioning as technology enables more

powerful computing and more efficient processes with increased agility.

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Top pharmaceutical companies will likely have to directly consider and contend with all technologies

and processes described in this IDC TechScape. In addition, as many organizations increasingly

virtualize many of their processes, they will still need to deal with these technologies and processes

through their vendors and partners. Foundationally, top pharmaceutical companies should have an

extensible technology road map in place that allows them to maintain a standardized approach to their

technology implementation efforts across their broad ecosystem. Beyond these foundational efforts,

the approaches described in the General Guidance section should apply to the companies' preferred

technology adoption philosophy.

Emerging and Midtier Biopharmaceutical Companies

In most cases, emerging and midtier biopharmaceutical companies should be able to focus their

technology and process road map primarily on functional technologies and processes used in the

clinical trial space, since they have likely made only limited investments in IT infrastructure. In

differentiating these companies from top pharmaceutical companies, emerging and midtier companies

typically depend more heavily on external service providers for their clinical trial efforts (especially

contract research organizations and clinical IT service providers). The increased dependence on

external service providers suggests that vendors supporting life science clinical trials should also

examine their technology road maps relative to this IDC TechScape to ensure that they are capable of

delivering services to their customers in a timely fashion (both functional technologies as customers

increasingly demand these services and infrastructure as increasing operational efficiencies limit cost

growth).

General Guidance

Early Adopters

From an IDC perspective, early technology adopters are more aggressive than the norm, seeking to

gain early benefits from technologies that have the potential to transform the business. In addition,

these organizations routinely seek to foster an open innovation mindset in their people, enabling the

organizations to embrace rather than fear risk. Within the IDC TechScape framework, early adopters

are expected to be at par or ahead on key initiatives within both the incremental and the

transformational categories with an eye toward aggressive implementation of new technology

opportunities as they arise. IDC expects that within their core focus areas, early adopters are likely

significantly ahead of industry adoption progress, especially in the area of transformational technology

adoption:

Based on their increased risk tolerance, early technology adopters should consider emerging

transformational technologies outside of their core competencies for benefits to their organizations.

With organizational efficiency and effectiveness initiatives maturing, early technology adopters should review opportunistic technologies to ensure that progress exceeds average industry

progress with a view toward maximizing both near- and longer-term performance metrics.

Mainstream Adopters

Most organizations are likely to be in the domain of mainstream adopters, with only limited investments

in promising, but unproven, technology innovations outside of their core focus. Mainstream adopters

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are somewhat risk averse with very limited tolerance for failure. Since this IDC TechScape is

normalized to these buyers, technology adoption progress is expected to be aligned for all

technologies with mainstream adopter expectations:

Likely falling into a "fast follower" mindset, mainstream adopter companies should validate that their technology innovation initiatives, particularly with the incremental technology category,

are in line with overall average industry progress.

With a view toward longer-term opportunities, mainstream adopters should consider focusing

their technology innovation budgets on core technologies that reside in the transformational category.

Cautious Adopters

For those organizations that would be categorized as cautious adopters, technology innovation is not a

significant priority when compared with operational issues. Operational efficiency and effectiveness

are foundational drivers within these organizations, and incremental progress in technological

innovation is the norm. Cautious adopters likely lag behind their mainstream peers with regard to

adoption progress in the incremental category and may have little, if any, active technology initiatives

based on technologies residing in the transformational category. Even within the supportive

opportunistic category, cautious adopters are likely lagging behind their peers with regard to

technology adoption, with the exception of those initiatives that can clearly demonstrate near-term ROI

to support improved operational efficiency and effectiveness while concurrently raising no regulatory or

quality concerns:

With ongoing external pressures continuing to threaten the status quo, it is becoming

increasingly difficult to retain traditional business models. Cautious adopters should consider targeted technology investments in areas expected to become near-term issues (e.g., the upcoming data tsunami and effectively collaborating in an increasingly global ecosystem).

LEARN MORE

Related Research

Business Strategy: Disruptive Innovation — Transformational Change Coming in Life Science R&D (IDC Health Insights #HI251770, October 2014)

Business Strategy: Transformational Times — Preparing Life Science IT for the Age of Genomics (IDC Health Insights #HI249557, June 2014)

Cloud-Based Business Transformation: Industry Case Studies (IDC #243275, September

2013)

Perspective: Patient Centricity — The Key to the Future of the Life Science Industry (IDC

Health Insights #HI242630, August 2013)

©2015 IDC #254210 22

Appendix

Interpreting the IDC TechScape Figure

The IDC TechScape study is both a strategic planning tool and a tactical decision-making tool. It's

designed exclusively for technology professionals in IT buyer organizations. This audience includes

CIOs, IT directors, IT managers, and IT architects and IT buyers from within business lines and

functions:

Strategic planning tool. IDC TechScape research offers a view into where a technology exists within its overall adoption life cycle. Technologies in the early stages of evaluation and

deployment are riskier investments than those further along in the adoption life cycle that are already being deployed more broadly. IT strategists can use this information to decide when a technology or group of technologies might be ready for adoption, given their organizations'

preferred level of risk.

Tactical decision-making tool. Because Figure 1 provides insight into where a technology

exists within its overall adoption life cycle and its associated risk, the IDC TechScape can be used to determine whether or not a particular technology should be adopted immediately or at

some point in the future when the adoption risk is less.

IDC TechScape Methodology

This IDC TechScape explores technology and/or management arenas characterized by one or more of

the following:

A single technology that has the potential for huge positive impact in the near future

A general technology area represented by multiple different technologies such as cloud, big

data and analytics, mobility, social business, datacenter, and security

A group of technologies that must come together to support a particular business process or

objective

Supporting technologies that, while not directly driving clinical development, have the potential to create significant competitive advantage

Synopsis

This IDC study uses the IDC TechScape model to provide an assessment of both industry-specific and

industry-agnostic technology adoption supporting the worldwide life science clinical trials market. The

IDC TechScape is an evaluation model based on a comprehensive framework and a set of parameters

that assess a technology's adoption progress relative to one another and to those factors expected to

be most conducive to success in a given market over both the short- and the long term. In breaking

technologies into three major adoption categories, transformational, incremental, and opportunistic,

the IDC TechScape aspires to provide IT buyers with an industry snapshot as to where specific

technologies lie today relative to current industry best practices. In addition, the IDC TechScape

identifies technologies likely to become best practices in the future and their current state of adoption

maturity relative to each other. Within our discussions of individual technologies, we also identify our

analyst's best opinions regarding key momentum factors, highlighted as IDC TechScape Spotlights,

where we rate technologies based on adoption speed, risk, and market interest.

©2015 IDC #254210 23

"Modernizing the clinical trial process requires a confluence of relevant technologies. With this study,

we provide our clients with a way to categorize those technologies and construct an optimal

investment strategy." — Alan Louie, research director, Clinical Development, Strategy and Technology

About IDC

International Data Corporation (IDC) is the premier global provider of market intelligence, advisory

services, and events for the information technology, telecommunications and consumer technology

markets. IDC helps IT professionals, business executives, and the investment community make fact-

based decisions on technology purchases and business strategy. More than 1,100 IDC analysts

provide global, regional, and local expertise on technology and industry opportunities and trends in

over 110 countries worldwide. For 50 years, IDC has provided strategic insights to help our clients

achieve their key business objectives. IDC is a subsidiary of IDG, the world's leading technology

media, research, and events company.

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