Acceliant, a global technology provider of innovative solutions in eClinical trials, today released a white paper entitled "Switching EDC Platforms to Rescue In-flight Clinical Trials." The white paper examines how a robust EDC platform supports lower operating costs for the global life sciences market.

1. White Paper
Switching EDC Platforms to
Rescue In-flight Clinical Trials
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2. Overview
The selection process for utilizing electronic data capture potentially extraneous costs that should be eliminated.
(EDC) is thorough, challenging, and time consuming. It is The Acceliant EDC and professional services teams have
conducted with qualified individuals and teams reviewing invested more than one year in researching the
systems that appear to meet various functional underlying issues of EDC failures to help dissatisfied
requirements and display the necessary performance on customers establish a path to successfully switch from an
stability and performance. A pharmaceutical, biotech, EDC platform. The switch can be accomplished with
CRO or a medical device manufacturer invests minimal risks, in less time, and with fewer frustrations.
considerable time and money in the selection process. This whitepaper delineates Trianz findings and establishes
Ultimately, a decision is made and a platform is selected. an approach to successful migration from a non-
The decision carries with it many implications for the performing EDC platform. Ultimately, the Acceliant team
organization and its eco-system of partners before and delivered a superior platform and experienced zero post-
during the clinical trials. The decision will impact the end migration problems, resulting in a lower total cost of
ownership to the client.
result data report. An entire eco-system must be trained
and oriented towards a new system, including its Understanding Client Imbroglio and Point of No
processes, reporting tools, and various controls in
Return to Avoid Dissatisfaction with EDC Platform
handling trials. Each of these aspects involves credibility
and Vendor
and a time and effort investment by all involved in the
clinical trial. No EDC customer should ever be in a position where
dissatisfaction levels reach a point of no return.
During trials, however, if these systems do not
Unfortunately, EDC issues occur more often than not in
consistently meet the requirements of an initial study or
the pharmaceutical industry. Before examining the path
are too rigid to meet the changing needs of more complex
from a point of no return, let us understand the causal
long-term studies, it will leave the EDC client in a difficult
factors that contribute to dissatisfaction so that lessons
situation. The client can neither continue the studies
can be learned. From these lessons a preventive approach
smoothly nor easily switch to a new platform due to the
‘vesting’ in a current platform and the risks involved. can be implemented in the selection process.
There are two broad categories of issues that lead to a
In today’s economic environment, companies are
point of no return: Dissatisfaction with a platform and
continuously challenging existing cost paradigms and the
service communication or other issues with the software
expenses incumbent with manual workarounds. Short-
vendor. Both categories have a prolonged interplay that
term IT solutions to larger EDC problems can incur
often leaves customers with no recourse.
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3. In research conducted by the team on this subject, Trianz discerned a number of issues in both these categories. In the
first category-Dissatisfaction with the EDC Platform-customers cited a dozen reasons for wanting to switch to a new
platform. The most important reasons are cited in Table 1 below.
The investment by companies conducting a study
Table 1
creates a considerable reluctance to change after
the inception of the study. So, a considerable Top Reasons for Dissatisfaction with an EDC Platform
amount of effort is undertaken to resolve issues Buyer’s remorse: Functionality during usage differs from what was
demonstrated during the selection process
with the software vendor. In many cases, vendors
respond and do their best to resolve issues. This Functionality is incomplete and does not meet all requirements
results in the point of no return situation being Technical performance of system did not meet expectations
averted through dialogue, a client service
orientation, and a partnership approach by both Difficulty in usage causing sites to be reluctant in using the system
parties. As far as possible, EDC clients must Data errors and inconsistencies in trials
exhaust this approach in order to avoid
Lack of scalability and extensibility to meet new trial needs
deterioration.
Unfortunately, we found a significant number of
Table 2
clients reaching a situation of ‘imbroglio’ when all
the efforts do not yield positive results. The top Top Reasons for Dissatisfaction with an EDC Vendor
reasons cited by clients in this category are cited Does not demonstrate the necessary flexibility to address the issues we
face- a customer service orientation is lacking
in Table 2 on the right.
Takes a legal and contractual approach for a financial gain
At this stage, clients are in a situation where
Does not think our issues are important enough to be part of the overall
numerous patchworks, internal efforts, manual platform and its normal features
workarounds, and other ineffective solutions
Was a great partner early on-has now become too big to fail
become the channel for moving trials forward. All
of these approaches, however, incur significant Knows we are stuck due to trials being in-flight and risks of switching.
effort, time, and money, ultimately impacting Has no incentive to make the investments necessary to improve the
software
stakeholder satisfaction and financial margins.
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4. Breaking the Imbroglio by Employing the Acceliant Migration Framework
The decision to switch EDC vendors after initial deployment in a study is always difficult and risky. Switching to a new
EDC tool involves coordination and consensus development with a replacement EDC vendor, the sponsor, sites, data
management, regulatory, quality, biometrics, IT, finance, and other stakeholders within the study. In today’s economy,
the costs of managing patch-work solutions around a troublesome EDC are enormous.
Based on several interviews and live trial- based discussions, the Acceliant team developed a comprehensive framework
consisting of four major phases as outlined in the image above. Additional features utilized in Acceliant are the Unified
Trial Builder, which allows the setup of a CRF within weeks (including iterations and approvals), data-import technology
capable of mapping and importing data across several hundred fields, and scores of forms. Audit capabilities within the
system, as well as manual validation, provide failure-proof data migration.
Migration  Trial specific migration analysis, comprising CRF,
Needs and subject, ste, data, reports, and all aspects of the trial life
Risks cycle to ensure all needs and risks are mapped out
Migration  Mapping planning and dry runs of EDC based on a set up
Planning and of the actual CRF.
Communication  Logistics planning, training ,and communications to all stakeholders
Acceliant  Migration of trial data using Acceliant proprietary Auto-Migrate
Auto-Migrate framework comprising automated data migration processes.
Execution  Validation and parallel run of trials
Acceliant Migration  Trial stabilization and redress of post -
Stabilization
migration issues.
Framework
Case Study
Acceliant Migration Runs Error Free During a Live Trial for a $6B Pharmaceutical Company
Taking the Confusion out of the Client EDC Imbroglio
During the course of an implementation a major contract deficiencies were identified. Multiple rounds of
research organization (CRO) chose a reworked EDC discussions with the software vendor did not yield any
offering that was backed by a large software company. results and the pharmaceutical company ended up in the
After passing user acceptance testing (UAT) successfully, imbroglio earlier described. On one hand, they could not
the system moved to production and began collecting progress the trial in the existing system with an assurance
data. The initial success of the system gave the CRO that trial requirements would be met. On the other hand,
leverage to implement a second EDC trial and successfully switching to a new EDC platform would involve a
complete UAT for that trial as well. As the trial complete evaluation process and risks.
progressed, certain non-data issues and system
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5. Acceliant EDC Platform Proven Across Wide Range of Clinical Tasks
Acceliant is a proven holistic EDC platform in the marketplace. With a 10-year history and more than 300 trials
completed, Acceliant has been employed successfully across a wide range of clinical trials. Acceliant’s track record of
success is three dimensional. It is one of the few platforms that allows for both paper and EDC form of data capture.
Moreover, it has been used for trials ranging from Phase 1 to Phase IV and post market studies. And it has been used for
dozens of therapeutic studies as well as device-related trials.
Acceliant is a complete Web-based platform and perhaps the most comprehensive built on a single architecture. It is
multi-lingual and rendered on PC, mobile, and tablet computers. Acceliant also comprises a robust ePRO version. For
more details on Acceliant, visit http://www.acceliant.com
Tablet Web Mobile
3rd Party Site HCP Patient Self System
Administrator Notification Administrator
3rd Party
User Role Event
Groupware Messaging Personalization
Management Management Notification
IVRS
Form
Security Data Access CT Admin Session Query
Safety Processor
Document
LMS Import / Export Workflow Reporting Logging / Audit Coding
Mgmt
ORACLE
Planning the Migration to Acceliant
Table 3
Migration to the Acceliant EDC platform involved
Trial Parameter Statistics
coordination and consensus development with sponsors,
sites, data management, regulatory, quality, biometrics, Trial Stage IV
IT, finance, and other stakeholders. The planning began No. of Patients 30
even before the migration to give key decision makers the No of Visits 15
information they needed to make the right move with No. of Sites 20
minimal data, minimizing regulatory, and financial risks. A
No. of Edit Checks 336
comprehensive, fact- based migration plan was developed
No. of Data Points for Migration 300
by the team which helped business leaders make the right
decision. Length of the Trial in Years 5
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6.  Trial Specific Fit Analysis. The life cycle of the trial was visualized and the necessary features were clearly
documented. It was confirmed that the new EDC platform could be utilized through the life of the study without
major impact.
 Definition of Stability and Success Metrics. A clear understanding of what data migration, stability, and other metrics
would be used to indicate EDC rescue and retirement of the old system was established.
 Communications. The team established a communication plan with the pathways and structures necessary to ensure
both end users and members of any affected team would know the progress, impact, and SLA or resolution process.
 Risk and ROI Analysis. There were two trials under consideration. The risks and ROI involved was clearly defined for
both the trials. The decision makers initially decided to move forward with the migration from the existing EDC
system to the AcceliantTM Clinical Trial System for both trials. At the conclusion of this particular exercise, one trial
showed significant ROI and, because of the long study timeline, indicated a higher risk and thus became a candidate
for moving forward with migration. The second trial did not have significant ROI and it was decided to complete the
trial with the existing system.
 Execution Plan. The team developed the milestones encompassing all affected areas and set a realistic timeline for a
rescue, providing the resources necessary to implement the rescue on time and on or under budget. The necessary
budgets, processes, and timelines were approved and the project commenced.
Executing on the Acceliant Migration Plan
The complexity of the EDC, the export of data and work much like the old trial. Trianz professional services
subsequent import, and the validation process made were able to deploy CRFs within days. Trianz then worked
communication a cornerstone in the deliverable process. with data management to validate every screen and make
Client leaders , data management, and involved Trianz certain all screens performed as close to the original
professionals developed a consistent communication system as possible. As a bonus, the additional features in
pathway to ensure that no item was missed, while the the Acceliant EDC system allowed many fields to be
decision making team was involved fluidly to ensure the conditional, only appearing based upon other questions.
project was moving forward on budget and within the This improved the original deployment considerably and
was added into the deployment.
stated timeline. Research associates and project
assistants participated in the process to foster
communication with system users and to ensure that
everyone knew when a change was coming, and whether
that change’s impact would be minimal.
The Unified Trial Builder was utilized to develop the study
in the Acceliant EDC system. With the flexibility of
AcceliantTM and the powerful features built into the
Unified Trial Builder, the new system could be modeled to
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7. Two additional features were added by
Table 4
moving to Acceliant. The Acceliant EDC
Trial Parameters Elapsed Times
system allowed serious adverse events (SAE)
to be tracked more effectively, improving the Development of the Study Database in Acceliant 5 Days
process for that portion of the study. The Screen by Screen Validation of the CRF in Acceliant 1 Day
Acceliant EDC systems integrated coding
module allowed events and medications to Test Data Migration on Test Servers
be coded without externalizing the data. In Export of data from current vendor
this phase the training of the CRO data Import of test data 1 Day
management professional was conducted by Verification of transfer
Trianz.. The Trianz staff training allowed the Demonstration of new system
individuals to collaborate effectively and
consistently meet and often exceed Production Data Migration-Auto Migrate
deliverable times as they progressed through Export of data from current vendor
case report form (CRF) pages and data edits. Import of test data 2 Days
A detailed plan for testing and the necessary Verification of transfer
UAT was refined from the earlier draft and Demonstration of new system
delivered to the client data management
associates. Trial UAT in Acceliant 5 Days
Go-Live on Acceliant EDC and Retirement of Legacy EDC 4 Hours
For migrating data, the auto-import feature
set of the AcceliantTM EDC system became a Total Time for Acceliant Migration 18 Days
necessity. An export was requested from the
previous EDC vendor and, utilizing the power of the AcceliantTM import tool, the data was mapped to the new sets of
forms and fields. Because the data was being migrated as a duplicate, the same field specifications were utilized in the
Acceliant System that had been established in the previous EDC system. Of the data points, 316 were unique and
required manual mapping.
UAT Results and Acceliant EDC Acceptance
The data management group worked with stats and the The clinical and project groups were then utilized to train
Trianz staff to compare data in both the old system and users of the old system and the “go live” date was set.
the new system after the export/import process using Communication and teamwork played major roles as all
exports of data from both systems. To ensure compliance, communication pathways were utilized to ensure that no
it was imperative that every data point be verified in the user was left behind. The timeline and previously
system. After a careful review it was determined that the developed plans gave all staff at the CRO and Trianz
actual process was 100 percent accurate. professionals the ability to script the implementation
phase perfectly. Both studies were migrated in 2011, both
The system was released for UAT to data management,
had zero errors, and both achieved success.
followed by the clinical staff, and finally to the sponsor,
passing all areas with no major issues. Total time in UAT
was less than five working days including three internal
review days and two sponsor review days.
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8. EDC Migration to Acceliant Delivers Trial Assurance and Lower Total Cost of Ownership
The decision to switch an EDC platform for in-flight trials emphasized teamwork and communications. All of this
is not easy and is fraught with risks. A majority of can be executed in an average of three to six weeks
companies continue to plough forward with higher costs (Including planning time) and at reasonable and well-
and operational pains due to a failing EDC platform. In justified costs. This Acceliant Migration was successfully
today’s economy such costs should be addressed and low- used in migrating trials in critical stages of their life cycle
risk approaches for rescuing trials evaluated. without any errors or risks to the trial. Ultimately,
Acceliant delivered trial assurance, legacy EDC retirement,
The Acceliant team collaborated closely to develop a
lower operating costs, and peace of mind for all teams
model that facilitates a trial migration to Acceliant based
working towards the success of a clinical trial.
on a strong framework that allows for a proper trial-
specific feature evaluation, migration, risk assessment,
thorough plans, migration, and execution. This framework
About Acceliant
Acceliant is a comprehensive clinical trials platform developed by Trianz. It is a multi-lingual platform that provides for
paper and EDC form of data capture for therapeutic as well as device trials from Phase I through IV. With more than 300
successful trials, Acceliant has emerged as a tier-1 platform alternative for many clients. For further details on Acceliant,
please visit http://www.acceliant.com
About the Author
With nearly 20 years of experience in the biomedical field, Ven Thangaraj, CTO, has been responsible for Acceliant since
the platform’s inception. He partners with numerous clients in evaluations, deployment, and operations of clinical trials
using Acceliant. He also consults for top management and data management clients at pharmaceutical, device
manufacturers, CROs, and biotech companies on clinical trials from lab phase to all further stages of the lifecycle. Ven
earned a B.S. degree in biomedical engineering from the University of Illinois in Champaign-Urbana, Illinois and a second
B.S. degree in mechanical engineering from Rensselaer Polytechnic Institute in Troy, New York.
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