industry survey: global trends and experiences with software-as-a-service tools for clinical data...

Industry Survey: Global Trends and Experiences with Software-as-a-Service Tools for Clinical Data Management

Kevin F. Shea Senior Director, Clinical Solutions kshea@c3i-inc.com

Characteristics of SaaS

» Network-based access to commercially available software

» Activities – for example, maintenance, validation – managed from central locations

» Enabling customers to access applications remotely via the Web.

» Application delivery typically closer to a one-to-many model

» Centralized feature updating

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Potential Benefits of SaaS

» Data Center infrastructure and resource cost savings

» Faster implementation, more seamless maintenance

» Focus budgets on competitive advantage rather than infrastructure

» Risk management

» Monthly obligation rather than up front capital cost

» Flexibility and scalability

» Reliability

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Purpose of our Survey

» Background �  Systems that serve non-CDM markets are well-established in SaaS

models

�  To date, SaaS CDM tools have had limited/mixed success gaining acceptance in the user community

» Purpose of the Survey

�  Update our understanding of the CDM user community’s attitudes −  CDM technology solutions −  Factors that impact acceptance of SaaS CDM

�  Profile customers’ experiences with SaaS technology, clarify their uses, and their needs for the near future

�  Clarify the factors that drive user acceptance and satisfaction with these tools and contrast concerns with on-premise and SaaS systems

�  Attempt to extend our understanding of the market uptake of SaaS CDM tools

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Survey Specifics

» C3i conducted a follow-up survey among the Clinical Data Management (CDM) community

�  Original 2009 – First survey completed, published white paper, 2010

�  2011 – Second Survey, published white paper in 2012

�  Utilized Survey Monkey

�  Invited 1600 people from 400 organizations to participate

�  Based on CDM Job Role/Title match in C3i’s contact database

�  Incorporated an incentive

�  104 respondents (6.5% response rate)

»  Survey Questionnaire �  24 questions created by Dr. Mike Lawless and C3i personnel

�  Designed to assess respondent’s

−  Perception of current SaaS uptake in Data Management groups

−  Overall challenges in CDM

−  Attitudes influencing the suitability and adoption of SaaS CDM solutions

−  Identify the benefits and risks of SaaS CDM solutions

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Survey Respondent Profile

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78%

14%

2%

6%

0% 20% 40% 60% 80% 100%

Pharma/Biotech

CRO

ACO

Other

Respondent Organization (n=65)

Most respondents (78%) work at Pharma/Biotech companies, with CROs representing the balance.

Survey Respondent Role

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0% 5% 10% 15% 20% 25% 30% 35%

C-level VP/EVP Director

Manager Associate

Other

Respondent Role (n=62)

Most respondents were at the Director or Manager/Assoc. Manager level in their organization.

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Survey Respondent Department

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0% 10% 20% 30% 40% 50%

IT

CDM

Regulatory

Research

ClinOps / PM

Respondent Department (n=64)

Most respondents were in CDM or IT departments, with less than 10% in either ClinOps or Research.

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Clinical Technology Experience

Most respondents (93%) were experienced users of clinical technology software

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0% 20% 40% 60% 80%

EDC

TMS/Coding

CTMS

Safety

Other

Experience with Clinical Technology

Note: “Other” includes SAS, Document Management, PM systems

Current and Future SaaS Adoption

Among all respondents: » The estimated percentage of Life Sciences companies who

have adopted SaaS CDM tools ranged from 20% to 40%

» 45% of all respondents expect the industry to realize “significant” growth in the adoption of SaaS CDM tools over the next 24-30 months.

» Both results represent slight but solid increase over our first survey results

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Evaluating SaaS Technology

» Half of the respondent’s companies’ had not yet formally evaluated SaaS CDMS solutions

» More than a quarter had evaluated at least one solution in the past three- to six-months

» Overall, the areas of concern for adoption of SaaS:

�  Data security (89%)

�  Control/accessibility (72%)

�  Cost (66%)

�  Ability to customize (60%)

�  Software validation (60%)

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Satisfaction with SaaS Clinical Tools

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74%

78%

88%

88%

0% 20% 40% 60% 80% 100%

Electronic Data Capture

Safety

Clinical Trial Management

Thesaurus /Coding

Good Satisfaction with SaaS Tools

Among SaaS users, a high degree of satisfaction across the common set of tools.

Non-SaaS Users: Concerns with SaaS

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1% 32%

71% 75% 77%

85% 86%

93%

0% 20% 40% 60% 80% 100%

Other (please specify)

Physical location of servers

Ability to customize

Extensibility/Scalability

Cost

Data Security

Control/Accessibility

Software validation

Concerns about SaaS Solution

Among non-SaaS users, a level of perceived risk across six key areas

All Respondents: Impact of SaaS CDM

The areas of operations perceived to be most impacted by the change to a SaaS CDM solution, across all respondents: » System Integration (59%)

» Data Extract and Reporting (45%)

» Workflow Processes (36%)

» Training (35%)

» User Support (33%)

» System Update/Availability (33%)

This is an assessment of overall change, with no specification of positive or negative.

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Summary of Survey Results

1.  Respondents were experienced CDM workers, representing pharma/biotech and CROs.

2.  Little variation in results across geographic regions

3.  Uncertainty about the expected value of SaaS over current processes has decreased since our first survey.

4.  High degree of overlap between the perceived benefits and areas of risk in SaaS CDM solution �  Perception is that SaaS will enhance Quality, Software Validation,

Usability

�  Concerns with SaaS are Software Validation, Data Control/Accessibility, and Data Security

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Conclusions

» Systems that serve non-CDM markets are well-established in SaaS models. However, life science tools have had slower rates of uptake.

�  General conservative approach of industry

�  Concerns around compliance and economics

» At the market level, diffusion of SaaS CDM as an strategy remains in the early mass market phase, but has shown growth since our first survey

» At the individual company level, understanding and acceptance of SaaS as a solution base has grown

�  Benefits and risks are more clearly delineated

�  Successes of the “Cloud” within and outside of Life Sciences have had time to become understood and accepted

�  Perceived level of risk appears to be decreasing

Follow on survey that uses “cloud” terminology would be helpful to further understand market and corporate trends

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Questions??

Please stop Booth #215 for answers to your questions and further discussions

Kevin Shea +1 610-772-5726 kshea@c3i-inc.com

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Presenter Biography

»  Kevin Shea (kshea@c3i-inc.com), Senior Director, Clinical Solutions, C3i, has been involved in the Pharmaceutical/Life Science industry for 12 years, with an emphasis on clinical technology, clinical data management, clinical operations, and associated business processes. He has account director responsibilities for a number of C3i’s clients and leads C3i’s BPO services offering, which is a set of solutions providing hosting and services for OC/RDC, TMS, and CTMS.

© 2012 C3i, Inc. Confidential and Proprietary to C3i, Inc.