1) The document discusses best practices for ensuring study success through the effective use of electronic data capture (EDC) technology. It outlines key factors like study setup, risk-based monitoring, data entry and reporting, safety reporting, data integrity and quality, and database lock. 2) Ensuring quick data entry and minimal errors is essential for success. The document advocates partnering with an EDC provider that can offer guidance, support innovative tools for data quality, and work flexibly with other systems. 3) OmniComm's EDC system TrialMaster is highlighted as providing features that streamline processes, catch errors early, and facilitate risk-based monitoring and post-study data access to meet regulatory standards

1. 1
The Essential
EDC Partnership
Strategy for
Ensuring Study
Success

2. 2
Contents
Introduction.................................................................................................................... 3
Study Setup .................................................................................................................... 5
Risk-Based Monitoring ................................................................................................ 6
Reporting & Data Entry................................................................................................ 8
Safety..............................................................................................................................10
Data Integrity & Quality..............................................................................................12
Database Lock .............................................................................................................14
Conclusion.....................................................................................................................15

3. 3
Introduction
Results of a 2014 study examining FDA drug approval
rates and trends of new molecular entities showed that
26 percent of all submissions were never approved.
Data-related factors — specifically, missing data, data
integrity, and inconsistencies — accounted for 16
percent of new molecular entity submissions that
were never approved.1
Electronic data capture (EDC)
technology, and the way it is utilized, can be directly tied
to every one of these factors.
The metric "cycle time from patient visit to completed
eCRF data entry" is highlighted in an executive summary
published by The Metrics Champion Consortium
as being central to the Risk-Based Monitoring
environment.2
Arguably, the referenced cycle metric is
essential to any use of an EDC solution. The longer the
gap, the higher the probability for errors – missing data,
compromised data integrity, and inconsistencies.
Sponsors often employ teams of SAS programmers who
carry the weight of getting poorly organized data ready
for submission after study close-out. But there is no
reason that the in-house team should be left to wrestle
with data at the end of a study to prepare it for the
FDA. There is a better way to approach data that yields
far more favorable results. It really does start with your
choice of an electronic data capture (EDC) technology
and the company that provides it.
1 http://jama.jamanetwork.com/article.
aspx?articleid=1817795
2 http://www.appliedclinicaltrialsonline.com/mcc-metric-
month-blog-risk-based-monitoring-metric
There is a better way
to approach data
that yields far more
favorable results. It
really doesstart with
your choice of an
electronic data capture
(EDC) technology and
the company that
provides it.
26 %
of all submissions were
never approved

4. 4
Challenge
Data is a continuous, connected, singular arch throughout
a study. It is not separate from the study, and it is not a
different component at various stages along the way. The
study sponsor and partner EDC solution provider are
responsible for creating study protocols and building out
the system to better ensure site adherence and quality
data. It is therefore imperative to partner with a provider
that demonstrates a commitment to success through
continued innovation.
What features have they developed for their system
to minimize data errors? Are you confident that their
support team has the experience to guide your study to
successful close? Do you know what site users say about
using their system? How are they working to maximize
operational efficiencies for example, lowering monitoring
costs through advancements in Risk-Based Monitoring
(Dynamic Monitoring)?
Overview
This white paper discusses the data needs throughout a
clinical trial and explains how an EDC partner should work
in concert with the study sponsor, providing the tools,
guidance, and support necessary to help ensure study
success. OmniComm System’s approach of embracing
and actively facilitating open integration between its
TrialMaster®
EDC solution and other electronic clinical
systems changes the relationship between the EDC
solution provider and the sponsor and/or contract
research organization (CRO).

5. 5
Study Setup
Doing it correctly leads
to smoother study
management and a
successful database
lock at the end.
Doing it incorrectly
means spending
valuable time and
money on cleaning up
data throughout the
study and delays the
database lock.
To initiate a new study, a sponsor and/or CRO finalizes the study
protocol, selects investigative sites, and sets up the study management
systems, including the EDC solution. The way the EDC system is set
up affects the entire clinical trial. Doing it correctly leads to smoother
study management and a successful database lock at the end. Doing it
incorrectly means spending valuable time and money on cleaning up
data throughout the study and delays the database lock.
Ideally, an EDC partner works with a sponsor and/or CRO during study
setup to design a system that will meet the ultimate goal of minimizing
unnecessary data. With its TrialMaster®
EDC Suite, OmniComm provides
not just the necessary software, but expertise and support from its
team of experienced industry professionals.
OmniComm will work during study setup to:
• Reduce cost and time by streamlining study build time lines and enforcing
standards across studies.
• Re-use complex study designs and components across trials leveraging industry
standards
• Manage data standards for submission.
• Provide rapid study build and design support regardless of clinical phase,
therapeutic area or study style.
• Share study design using industry standards with related applications, ex. ePRO.
TrialMaster®
EDC comes equipped with a library of standard forms for
the study team’s use during system build and throughout the study.
The OmniComm team works with sponsors to select and customize the
standard case report forms (CRFs) and corresponding electronic case
report forms (eCRFs) at the beginning of a study, an integral component
to building a successful EDC framework. The team references the Clinical
Data Acquisition Standards Harmonization as the standard in the Clinical
Data Interchange Standards Consortium portfolio that integrates the
Submission Data Tabulation Model requirements into the CRFs.

6. 6
The decision of whether to use risk-based monitoring,
also called targeted monitoring, is a vital decision with
the potential to affect the entire study. Implementing
100 percent source data verification (SDV) in a study
significantly increases monitoring costs. Such costs
can account for 30 percent of the total study budget,
according to some estimates1
. In the past, the
pharmaceutical industry has been reluctant to adopt
new methods that could reduce monitoring costs due
to the ambiguousness of the FDA’s guidance on the
subject.
However, in 2013, when the FDA issued its final
guidance for risk-based monitoring in clinical
investigations2
, the industry made a drastic change. The
new guidance supports selective monitoring, including
less than 100 percent SDV, provided that the selective
approach is justified in a risk-based monitoring plan.3
Suddenly, sponsors and CROs needed support for
the new approach, so OmniComm added three
capabilities to its TrialMaster®
EDC Suite to meet this
demand throughout the clinical trial process:
3 Risk-BasedMonitoringwithTrialMaster®
4 http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf
5 Risk-Based Monitoring with TrialMaster®
Implementing 100
percent source data
verification (SDV) in
a study significantly
increases monitoring
costs.
Risk-Based Monitoring

7. 7
Dynamic monitoring
Allows sponsors/CROs to selectively mark
forms for SDV.
Central source review
Enables central review and/or SDV of a
scanned, auto-redacted copy of selected
patient source documents.
Centralized monitoring
Reports highlight questionable data and
high-risk sites using a robust reporting
solution and advanced key risk indicator
reports, optimized for proactive and
reliable issue detection.
In concert with the rest of its capabilities, TrialMaster®
EDC delivers high
levels of automation and control for companies looking to adopt a risk-
based approach to monitoring.

8. 8
Data Entry & Reporting
Traditionally, site monitors spend countless hours
reviewing source documents and CRFs, matching them
to the entered data. Visits that could be completed in
one or two days are extended to three as monitors sort
through data entry errors and create queries for each
one. Site staff must then go back over all the queries to
correct them. Even so, at the end of the study, site staff
and monitors are left resolving thousands of queries to
meet database lock timelines. When a study utilizes a
system that makes entry simple for the site staff, with
standardized eCRFs and ongoing training, the number
of errors and resulting queries are minimized, saving
the sponsor time and money. The queries that do
arise are submitted immediately for resolution. Timely
reporting also gives project managers the opportunity
to assess the quality of the CRFs and site staff training
— and to make changes, if necessary.
In a recent survey, three out of five investigative sites
reported that they preferred TrialMaster®
to other
market leaders.4
The built-in user-friendly features
simplify implementation and ongoing training. Available,
ongoing e-learning gives site staff and monitors the
opportunity to train themselves and refresh their
knowledge of the EDC system at their own pace rather
than having to learn everything there is to know about
the system in one half-day investigator meeting.
6 OmniComm Systems
TrialMaster®
makes
data entry and
reporting a far less
cumbersome process
for site staff and
monitors.

9. 9
Guided Data Entry
One of TrialMaster’s®
standout features,
Guided Data Entry, saves time and money
while guaranteeing more accurate data. In
contrast to other systems, which wait until
after submission to the database, to crawl the
reports for errors, TrialMaster®
saves site staff
and monitors countless hours of searching
through queries by flagging errors as soon as
they are entered.
Reduce costs
Monitoring typically accounts for 30 to 40
percent of the entire study budget, with
the majority of that cost funding on-site
visits. Combined with risk-based monitoring,
OmniComm’s innovative software for data
entry and reporting means far fewer hours
and resources are needed for monitoring
activities. This reduction in the number and
length of visits is one reason that direct users
prefer TrialMaster®
over other programs.

10. 10
Safety is vital to the running and outcome of every
clinical trial. While the goal is to avoid adverse events,
some are inevitable. According to 21 CFR 312.64,
investigators are required to “immediately report to
the sponsor any serious adverse event (SAE), whether
or not considered drug related, including those listed
in the protocol or investigator brochure and must
include an assessment of whether there is a reasonable
possibility that the drug caused the event.5
” Immediate
reporting directly to the safety system eliminates lag
time and gives the sponsor time to react accordingly.
Faster notification of adverse events can lead to earlier
and better decision-making, potentially saving hundreds
or thousands of patients from exposure to unsafe
medication.
In the past, doctors and investigators had to fill out
separate forms to be submitted to different entities for
every SAE, jeopardizing accuracy and consistency along
the way. With a robust EDC system, investigators enter
the data just once. The CDISC/CDASH Serious Adverse
Event Supplement published in November 2013 directly
addresses collecting SAE information through an EDC
rather than on paper.
7 https://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol5/pdf/CFR-2011-title21-vol5-sec312-64.pdf
In the past, doctors and
investigators had to fill
out separate forms to be
submitted to different
entities for every SAE,
jeopardizing accuracy
and consistency along
the way.
Safety
With a robust EDC
system, investigators
enter the data just
once.

11. 11
Appendix B of the supplement6
states:
Electronic data capture (EDC) is recognized as an efficient and time saving
method for capturing clinical data. EDC also offers a more efficient process
for SAE information capture than the traditional paper form; sponsors
can use information already available in the Clinical Data Management
System (CDMS) to populate the same data elements on an SAE report form.
Typically, such data are housed in a clinical study database. All SAE data that
are not extracted from the clinical study database are typically housed in a
separate safety database. The relationship between drug safety data and
clinical trial data that commonly manifests in two distinct data acquisition
processes can be enhanced by minimizing duplicative data collection and
easing the safety data reconciliation processes.
SAEs are typically reported to a pharmacovigilance or drug safety group that
is independent of the clinical research team and is dedicated to receiving,
clarifying, analyzing, and reporting SAE information in conjunction with
the investigative sites. TrialMaster’s®
SafetyLink module gives sponsors
and CROs the ability to set up safety reporting in line with study protocols,
regulatory guidelines, and the CDASH SAE Supplement. SAEs can then be
transmitted seamlessly to the safety system of choice.
8 http://www.cdisc.org/system/files/all/standard_category/application/pdf/cdash_sae_supplement_v1___3_.pdf

12. 12
The FDA expects data to be attributable, legible,
contemporaneous, original, and accurate (ALCOA).9
The Good Clinical Practice Inspectors Working Group
released its “Reflection paper on expectations for
electronic source data and data transcribed to
electronic data collection tools in clinical trials”10
in 2010, which added four additional attributes –
complete, consistent, enduring, and available when
needed (ALCOA+).
Data Integrity & Quality
Data integrity
To ensure data integrity, data must be main-
tained throughout its life cycle to make sure that
it is accurate and consistent11
. Collected data
must be genuine, with an audit trail to show
any changes. Adherence to ALCOA+ guarantees
that at every stage, a reviewer can return to the
original data and ensure that the correct changes
were made.
1 2 3
9 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/
ucm328691.pdf
10 http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guide-
line/2010/08/WC500095754.pdf
11 IS Practitioners Views on Core Concepts of Information Integrity

13. 13
Data quality
Data quality, meanwhile, means making sure
that the meaning, context, and intent of the
data are clear.7
A key aspect of data quality is
providing user access to data along with the
ability to organize it for business purposes.
These calculations, derivations, and other
transformations permit evaluation of a batch
of product and ultimately determine the
outcome of the study.
Database Lock
12 ahima.org
Together, data integrity and quality are the most important aspects of your study
data after safety. Both are products of a well-designed system. TrialMaster®
EDC provides the functionality to maintain data integrity and quality throughout
the entire study while OmniComm’s team provides the necessary support,
giving sponsors what they need to end their studies with clean data that meets
ALCOA+ standards.

14. 14
1 2
13 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/
14 TrialMaster® by OmniComm
Database lock, as dictated by industry regulations13
,
is the point after which data can no longer be edited.
However, there are several reasons that having data
available when needed was one of the attributes added
to the original ALCOA list. Sponsors require access to
their data during the study for ongoing management
and for export once the study has ended. Unfortunately,
database lock as experienced by many sponsors means
being locked out of their data — in other words, losing
access to the results of their own studies.
OmniComm works in conjunction with sponsor/CRO
systems while adhering to the FDA’s requirements for
data submission. Gone are the days when EDC required
just a data transactional system; now, it is expected
that data will be exported in a form that is ready to be
analyzed, so results can be promptly submitted to the
FDA. Sponsors can obtain CDISC SDTM datasets
within days of database lock with TrialMaster’s®
built-in data mapping and export utility tool.14
Through continued innovation, OmniComm has built a
system that meets a sponsor’s database lock and export
needs every time. A true EDC partner will not hold data
hostage the way an ordinary vendor might.
Through continued
innovation, OmniComm
has built a system
that meets sponsor
database lock and
export needs every
time.
Database Lock

15. 15
50,000+
Study sites
4,800+
Clinical studies
20,000+
Trained users
250+
Sponsors
55+
Countries
www.omnicomm.com
Conclusion
OmniComm is changing the way the
pharmaceutical industry approaches data,
because we know that data is at the core of
a clinical trial, not the result of a clinical trial.
Our innovative technology and philosophy
as an open integration system is unlike that
of any other EDC company. This is one major
aspect of our company that sets OmniComm
and our TrialMaster®
EDC Suite apart. We are
dedicated to being the industry’s leading EDC
provider.
Quality is the key
The quality of our software is exceeded only
by the support we provide. Our experienced
teams built the system we offer today, and
they are here to help our clients successfully
run their clinical trials. Our OmniComm
service records span 50,000+ study sites,
4,800+ clinical studies, 20,000+ trained
TrialMaster®
EDC users, and 250+ sponsors
across more than 55 countries. OmniComm
EDC technologies are used by four of the
top five CROs, seven of the 10 largest phase
I clinics, and all 10 of the top 10 cancer
research centers. We are an aid to the sites
and we are a true partner to every client.