Study Startup: New Battleground in CRO Differentiation Strategy - Oracle
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UNIFYING ACTION, ACCELERATING RESULTS.
WHITE PAPER
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Study Startup: New
Data Study
Design
Documents
eSignature
Services
Battleground in CRO
Capture Control SAE
Service
Differentiation Strategy Start-up
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Post
Conduct Marketing
Protocol
Deviation Signatures
Dictionaries
Patient Information Inclusion / Exclusion
Criteria
Subject
Management
This white paper describes why study startup aids CROs
in competitive differentiation of services by allowing
Document Exchange
them to implement more efficient operational practices,
by achieving predictability and better adherence to
timelines.
Copyright ©2019, Oracle and/or its affiliates. All rights reserved.
Contents
Executive Summary 3
Purpose-Built Study Startup Tools Aid CROs in Differentiation 4
A Purpose-Built Solution 5
Companion Data Driven Solutions 7
goBalto Analyze Dashboards with Study Startup Visualization 8
A More Competitive Future 10
References 11
2 Copyright ©2019, Oracle and/or its affiliates. All rights reserved.
Executive Summary
With the CRO market approaching a tipping point,
forward-thinking CROs are looking to differentiate
themselves as competition stiffens. Study startup is
one aspect of clinical development grabbing attention
from CROs looking to position themselves ahead of the
competition.
For CROs, differentiation is an opportunity as they evolve past
commoditized, tactical service offerings emphasizing lowest price in
favor of becoming risk-sharing strategic partners in the race for faster
and higher quality clinical trials.
3 Study Startup: New Battleground in CRO Differentiation Strategy
Purpose-Built Study
Startup Tools Aid CROs
in Differentiation
The drug development process is long, arduous, and costly, driving
many sponsors to expand their use of contract research organizations
(CROs). This move reflects sponsors’ sharper focus on core
competencies as they shift the management and conducting of clinical
trials to CROs. Research suggests a 7.4% compound annual growth
rate for the CRO market through 2019,1 and a market penetration rate
of 72% by 2020.2 Yet, at the same time, there are clues that this hefty
market penetration signals a maturing market,3 leading to eventual
slowing of revenue growth, possible reduction in the number of CROs,
and fewer new customers.
“
With the CRO market approaching a tipping point, forward-thinking
CROs are looking to differentiate themselves as competition stiffens. For CROs, differentiation
Study startup is one aspect of clinical development grabbing attention is an opportunity as they evolve
from CROs looking to position themselves ahead of the competition. past commoditized, tactical
Specifically, study startup remains a perpetual bottleneck. CROs that service offerings emphasizing
adopt purpose-built technology to address this challenge will be able lowest price in favor of becoming
to offer actionable information faster by tracking activation activities in risk-sharing strategic partners in
real-time, and generating accurate reports on document, submission, the race for faster and higher
and milestone status. This move will help CROs improve operational quality clinical trials.”
delivery, a major step toward differentiation,4 possibly the next
battleground for CROs.
For CROs, differentiation is an opportunity as they evolve past
commoditized, tactical service offerings emphasizing lowest price in
favor of becoming risk-sharing strategic partners in the race for faster
and higher quality clinical trials.4
The Study Startup Bottleneck
Study startup is an array of activities performed at the launch of a
clinical trial. This early stage of development includes traditional tasks
such as site selection and initiation, regulatory document submission,
contract and budget negotiations, and enrolling the first patient.5 It is a
slow process, complicated by the rising globalization of clinical trials,
and taking an estimated eight months to move from pre-visit through
site initiation.6
4 Study Startup: New Battleground in CRO Differentiation StrategyA 2014 report sponsored by the US Department of Health and Human
Services cites the already sluggish study startup process as stalled
further by sponsor-imposed barriers, such as complex internal review
methods and highly restrictive inclusion/exclusion criteria.7
Adding to the list of slowdowns are insufficient recruitment planning,
issues of poor case report form design, delays in site initiation,8 and
manual preparation of status reports, often from Excel spreadsheets.
Much of the study startup inefficiency stems from too many tasks still
relying heavily on paper-based or spreadsheet methodologies stored
in multiple systems, making it tough to track activity in real-time, view
trends, be audit-ready, and avoid bottlenecks. In an insightful article
detailing inefficiencies of study startup, Schimanski and Kieronski state
that CROs and their sponsors need to embrace innovative ways to Study Startup Challenges
operationalize start-up activities using technology that moves beyond for CROs
data gathering at the site level to enhance visibility at the country level.
• Site selection
• Scheduling of critical path activities, i.e.
As competition intensifies, CROs can add value to the clinical trial pre-study and site initiation visits
process by implementing more efficient operational practices to
• Identifying bottlenecks proactively
confront these very real study startup global challenges. For example,
forward-thinking CROs will want to know how long it takes to complete • Determining real-time study status
and cycle times
study startup tasks, such as site selection, or schedule critical path
activities, namely pre-study and site initiation visits (Chart 1). Using • Comparing sites for efficiency
technology to perform these tasks will help CROs achieve predictability • Training
and better adherence to the study startup timeline.
• Drug accountability
Chart 1
A Purpose-Built Solution
To date, CROs have stepped up by implementing eClinical solutions,
such as clinical trial management systems (CTMS), electronic data
capture (EDC), and the electronic trial master file (eTMF), but despite
the functionality they offer, a gap remains. None of these technologies
address study startup-specific tasks. CTMS provides a view of clinical
trial execution as the trial is unfolding, and the eTMF gives a regulatory
perspective on the level of completeness of essential documents. But,
what is missing is a purpose-built application designed to track study
startup activities while keeping content out of the eTMF that is not
ready for inspection. This application should also be able to provide
tracking of start-up transactions before critical points are reached,
allowing companies to make adjustments to stay on track.
5 Study Startup: New Battleground in CRO Differentiation StrategyOracle Health Sciences goBalto Activate Cloud Service is this type of
application. It is a cloud-based purpose-built study startup solution that
can provide a competitive edge to CROs. Specifically, it is a business
process facilitation tool designed to guide the user through study
startup using smart workflows that offer better visibility into which
activities are next.
Using an application program interface (API), goBalto Activate
integrates with existing eClinical functions to optimize data flow
among the integrated components, known as the “clinical stack”
(Figure 1).10 Data housed in these solutions, such as individual site
performance, country performance and submission activities, are
compiled, so the study team can view status in real-time. With this
information, goBalto Activate becomes the repository for in-progress
documents, and supports communication, reporting, tracking,
oversight, and data management. As such, the tool functions as
a single source of truth, and no time is wasted assembling status
updates.
SUBMISSION
STARTUP ENROLLMENT CONDUCT
& CLOSEOUT
MILESTONES
DATES
STUDY
STARTUP METRICS
SOLUTION
SINGLE SIGN-ON DOCUMENTS
Figure 1
Information contained in goBalto Activate only needs to be entered
once, and documents from the principal investigator’s database and the
investigator portal are accessed through a dashboard via a single sign-
on. This is a major improvement over having to logon to each solution
separately, as large volume stakeholders typically have to maintain
credentials for dozens of systems, contributing to reluctance to manage
collaboration online.11
6 Study Startup: New Battleground in CRO Differentiation StrategyAs a result, stakeholders may resort to legacy document exchange and
collaboration efforts, such as email, fax, and courier services.
Additional features of goBalto Activate include:
• More than 70 standardized country workflows to choose
from, including tracking site activation, protocol
amendments, quality reviews, and expiring documents
(Figure 2)
• Configurable to track any activity, document, submission,
and ad-hoc documents
• Real-time alerts help decision makers intervene
“
immediately, before a major setback has occurred, instead of
after the fact Spreadsheets are not
sophisticated enough to ensure
organizations are in compliance
with their standard operating
procedures (SOPs) and/or
regulatory requirements for
Activities, Milestones
documentation management
✓
and workflows.”
✓
✓
✓
✓
✓
✓
Figure 2
Companion Data Driven Solutions
To complement goBalto Activate, two other cloud-based purpose-built
solutions — Oracle Health Sciences goBalto Analyze Cloud Service
and Oracle Health Sciences goBalto Select Cloud Service—provide
actionable information to improve results of the study startup process.
goBalto Analyze is a reporting tool that creates reports using data
analytics to aid the CRO and stakeholders in viewing study status of
multiple studies. This functionality helps identify bottlenecks across
protocols by evaluating completion of documents on the critical path,
such as site contracts or an informed consent form, and tracks cycle
times amongst individual sites as well as countries (Figure 4). If a
report signals a trend toward longer completion time for contracts, for
example, the CRO can act quickly to steer lagging sites back on track,
or consider adding new ites.
Standard reports are supplemented with customized reports that can
be shared with team members via a simple click and an e-mail
address to authorize those team members to see a dashboard of the
reports.
Study Startup: New Battleground in CRO Differentiation Strategy
7The customized reports can provide visualizations as they drill down
into the details of:
• Document and submissions status
• Milestone status
• Task duration
• Country
• Site
• Team member
• Volume of work scheduled for the next quarter
goBalto Analyze Dashboards with Study Startup Visualizations
1.000
In Progress
5
This is a high level executive view of study progress by country with projected work to be completed.
This dashboard allows a functional manager and study manager to know the resource needs for the upcoming
weeks and months based on work completed to date.
Cycle name Cycle name
■
Pkg sent • IRB lnslitution Pl last name Pkg sent • IRB Pkg senl • SIV Pkg-Contracted
Study
■
Pkg sent• SIV
HLN124KOO
Pkg-Contracted 81.71 84.00 -43.86
HLN124K01
HLN124K02
HLN124K03
HLN124K04
HLN124K05 71.00 74.71 71.00
HLN124K06 49.71
HLN124K07 27.71 -39.43 -30.86
HLN124K08 22.86 .20.14
HLN1241goBalto Select is an end-to-end workflow solution designed to help
CROs avoid selecting non-active and non-enrolling sites. The tool
achieves this by eliminating manual site selection methods, which
often lack institutional memory, and by addressing issues caused by
collecting data on site capabilities, past performance, and investigator
background from disparate systems. goBalto Select combines internal
and external data sources to create a complete target site profile and
facilitate evidence-based site selection and feasibility.
The problem of non-enrolling sites has been an intractable one in the
clinical trials sector for decades, and has been the subject of many
articles and books. Despite continuous efforts, research indicates that
half of investigative sites under-enroll, 11% of sites fail to enroll a single
patient in a clinical trial, and only 13% exceed their enrollment target.
Also, Phase II-IV study timelines frequently have to be extended to
nearly twice their original length to achieve the study’s enrollment
goals.12 For too long, the process has been inefficient due to the lack
of real-time data indicating cycle times, site submission timelines, and
other factors. Without these data, the CRO, as well as the sponsor,
are at risk of selecting too many non-enrolling sites, which ultimately
drives up the costs and wastes valuable study startup time. Now, with
data flowing into goBalto Select from multiple sources, it is possible
to use this information to create a reusable master site profile of site
characteristics and performance. This includes:
• Enrollment data
• Cycle time performance
• Experience
• Profile information
• Data quality
The intent is to improve enrollment outcomes by identifying which
sites are more likely to enroll within the designated timeline and retain
those patients throughout the trial. This is accomplished by goBalto
Select’s data driven reporting on cycle times for each set of feasibility
and selection parameters, and the tracking of how well the CRO is
performing in recruiting the right sites (Figure 5).
9 Study Startup: New Battleground in CRO Differentiation StrategyA More Competitive Future
The issue of competition is destined to loom large for CROs, so
developing a strategy of adopting a study startup solution is a smart
way to handle this inevitability. By taking this approach, CROs are
aligning with sponsors’ efforts to refine their selection process for the
right CRO, possibly one that can beat the sponsor’s internal metrics for
completion of various clinical trial tasks.
Figure 5
These efforts by sponsors are destined to grow as they become more
sophisticated in their choice of CROs by assessing ability to conduct
clinical trials and generate quality data while adhering to timelines and
budget.4 As explained in a survey on CRO selection,10 there are a host
of deciding factors, such as experience and sound management of the
CRO/sponsor relationship, but use of disruptive technology
and ability to execute the project plan are also key. For example, the
survey defined “execute the project plan” as including country and
site selection capability, features that are trackable and transparent
with goBalto Activate and goBalto Analyze. And to improve patient
enrollment, technology such as goBalto Select is critical as it uses
current data and institutional memory to identify sites with a greater
likelihood of enrollment success.
The process of initiating clinical trials is cumbersome, challenging,
and often behind schedule, making study startup one of the poorest
performing aspects of clinical trials. As CROs fight to maintain market
share and ensure long-term survival, the next battleground may be the
improvement of study startup operations, and those companies able to
take those steps may be well-positioned to reap the rewards.
10 Study Startup: New Battleground in CRO Differentiation StrategyReferences
1. ISR projects a 7.4% compound annual growth rate for the CRO market through 2019. ISR Reports. February 12, 2015.
Available at: http://www.isrreports.com/isr-projects-7-4-compound-annual-growth-rate-cro-market-2019/
2. Research and Markets, Research and Markets:The new 2015 trends of globalmarket, Business Wire. January 30,
2015. Available at: http://www.businesswire.com/news/home/20150130005621/en/Research-Markets-2015-Trends-
Global- Clinical-Development#.VW3x01xViko
3. Anderson B. CRO Market View. Contract Pharma. February 25, 2008. Available at:
https://www.contractpharma.com/issues/2008-03/view_features/cro-market-view/
4. CRO differentiation whitepaper. ISR Report. September 2011
Available at: http://www.isrreports.com/wp-content/uploads/2013/04/CRO_Differentiation-ISR_Whitepaper.pdf
5. Lamberti MJ, Brothers C, Manak D, Getz K. Benchmarking the study initiation process.Therapeutic Innovation &
Regulatory Science. 2013;47(1):101-9. Available at: https://journals.sagepub.com/doi/abs/10.1177/2168479012469947
6. KA Getz. Uncovering the drivers of R&D costs. Proprietary presentation 2015, citing data from theTufts Center for the
Study of Drug Development.
7. Sertkaya A, Birkenbach A, Berlind A, Eyraud J, Eastern Research Group, Inc. Examination of clinical trial costs and
barriers for drug development. US Department of Health and Human Services. 2014.
Available at: http://aspe.hhs.gov/sp/reports/2014/ClinicalTrials/rpt_erg.pdf
8. Chung J. Bringing speed to study startup. Drug Discovery & Development. July 13, 2015. Available at:
https://www.rdmag.com/article/2015/07/bringing-speed-study-startup
9. Morgan C. Expediting study start-up across the globe. Applied ClinicalTrials. July 2015.
Available at: http://www.appliedclinicaltrialsonline.com/expediting-study-startup-across-globe
10. Wynden R. Using eClinical systems to speed up clinical trials understanding the roles of eTMF, CTMS, and study
startup solutions in the clinical trials process. goBalto 2015. Available at:
https://www.gobalto.com/etmf-ctms-study-startup-how-to-use-eclinical-systems-to-speed-up-clinical-trials-process
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