Download EDC? Not as easy as 1, 2, 3

EDC? Not as easy as 1, 2, 3
Making the drug development process more efficient is an everyday challenge for the pharmaceutical
industry. Selecting the right technology provider and solution is a large part of this challenge, the
importance of which should not be ignored.
A
EDC systems available. A small sampling include: DataTrak,
eTrials, InForm, InSpire, OpenClinical, Rave, Oracle Clinical /
RDC, SynCapture, and TrialMaster.
The goal of an EDC system is to support the unique
requirements of its users and enable them to efficiently perform
the functions and tasks required for successful project delivery.
However, in order to get to that point the right process should
be dutifully followed. It’s worth the substantial time and energy
it will take to research what capabilities the EDC will need to
perform because it takes in excess of 80 hours to get trained on
most systems, and six months to a year to gain full proficiency.
Commitment and investment are correlated, and it must
be taken into account that the costs associated with changing
systems can be substantial. Costs can easily exceed $1 million
once data migration, validation and re-training has been factored
in, before even factoring in hardware and licensing expense, so
the long term financial return must be evaluated. It is important
to make sure research is done thoroughly on the front end, and
return on investment (ROI) has been weighed carefully. Plan to
take anywhere from three to six months to review the EDC
platforms that are available in the market. Every client
project will have unique requirements, and those should
System 3 System 4
be thought about critically during the research phase.
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✓
s clinical trial costs continue to rise, and processes
become more complex, efficiency is increasingly
critical to drug development. In today’s fast-moving
and globalised marketplace, the industry is challenged to
increase productivity while reducing costs, and using appropriate technology to optimise the process is a large part of that
puzzle. As such. there is an increased urgency to have the right
electronic data capture (EDC) platform in place, from protocol
development to delivery.
EDC systems are designed to collect clinical trial data
directly from clinical sites over a secure web-based connection.
Common components of EDC systems include: an administrative console for creating users and managing role-based security,
a graphical user interface (GUI) for data entry, a validation
engine to execute edit checks and verify the validity of the data
entered into the system, a developers’ interface to build the
electronic case report forms and programme edit checks, and a
reporting module providing both standard and ad hoc reporting
capabilities and ability to export data. There are a number of
Figure 1 Key features
Feature
System 1
System 2
Ad-Hoc Reporting
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CDISC Certification
✓
✓
Document Management
✓
First steps
✓
Electronic Health Records
Integration
ePRO Capabilities
Inventory Tracking
✓
✓
✓
IRT / Randomization
Capabilities
✓
✓
Lab Values/Ranges
Management
✓
Medical Coding
(MedDRA/WHODD)
✓
✓
✓
✓
✓
Multi-Language
✓
✓
On Demand Export
✓
✓
✓
✓
✓
✓
✓
Paper / Double Data
Entry
✓
✓
PDF Archiving
✓
Safety System Integration
✓
✓
✓
Site Payment Capabilities
Web Services / Data
Integration
Source: Synteract
© Informa UK Ltd – April 2012
✓
✓
✓
✓
The first step in selecting the right EDC platform is to
identify high-level system and end-user requirements. Do
not let affordability be a major factor at the start; instead
focus on ROI and efficiency gain. Bring in end-users
and stakeholders early to determine what tasks they will
require the system to perform. Ask the question, “What
features would the company want if this system was
being custom built?”
Make a list of those attributes in a spreadsheet
(anywhere from 50-500). When developing the spreadsheet it is good to do one-on-one interviews, and
then brainstorm within a group setting to get multiple
stakeholders’ perspectives simultaneously. Separate
requirements into “must have” and “nice to have” being
sure to avoid subjective requirements, and instead ask
smart, concrete questions. It should be noted that subjective criteria such as “system had an attractive user
interface” can be gathered via questionnaire and then
presented objectively (For example, eight of 10 endusers preferred the user interface in System X more than
System Y). An example of this can be seen Figure 1.
Secondly, identify and evaluate vendors and systems.
Use the vendors’ “sand box” environment to enter sample
data, evaluate workflow, and test performance. This
sounds intrinsically easy to assess, however, it can be
very difficult for stakeholders to find the time outside of
their normal job duties to test a new EDC platform. One
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Figure 2 Weighted evaluation
Base Score
Weighted Score
Category
"System 1
(1-Low - 3 High)"
"System 2
(1 Low - 3 High"
Weighting
"System 1
Weighted"
"System 2
Weighted"
Support
1
2
4
4
8
Training
3
2
4
12
8
Hosting (Service/Uptime)
2
3
4
8
12
Hosting (Costing)
2
1
5
10
5
Post-production changes
1
2
5
5
10
Database backend
2
3
3
6
9
Ease of integration
2
1
4
8
4
Product stability
2
3
4
8
12
Product adaptability
2
1
3
6
3
Large user base
2
3
3
6
9
Corporate culture fit with
Synteract
2
1
3
6
3
Corporate culture
2
1
1
2
1
Bug free system
2
2
3
6
6
SDLC control
2
2
3
6
6
Vision of product
3
2
2
6
4
Ability to implement
2
1
4
8
4
Features
2
2
3
6
6
Foreign language support
3
1
1
3
1
Total Rating
37
33
--
116
111
Source: Synteract
solution is to develop a clearly defined charter document that
lists all stakeholders and their expectations with regards to the
new system. Make them aware and accountable for their time
needed to test new systems.
The third step is to eliminate systems that failed to meet
high level requirements and re-evaluate the remaining systems.
At this point, it should be clear what the EDC system will need
to accomplish. If one platform can do a lot more or has a higher
pedigree, that does not mean it’s the correct platform for your
business. For example, there is no reason to pay more for a
system that will translate data into other languages if studies
are only being conducted in English. Think critically about the
functionality that the system will need to supply, coupled with
the goal of creating an objective and quantifiable method of
ranking EDC systems.
Fourth, develop a vendor audit questionnaire that can be
sent to the EDC platforms that have been selected for the short
list. The questionnaire will ask them to rank how they perform
on each functionality and confirm that the system complies
with relevant regulatory requirements (e.g., 21 CFR Part 11).
Be wary of any platform that says it can perform above average
on all functionalities; no system hits every feature, and the
more feature rich the system is, the harder it may be to use.
The fifth step is to identify detailed functional and user
requirements. Evaluate how well the system meets each
requirement and apply a weighting scale based on importance.
In figure 2, a three point scale is used for both the requirements
evaluation (1-Below, 2-Normal, 3-Excels) and the weighting
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(1-Low, 2-Medium, 3-High) but a more granular, 5-point or
10-point, scale can also be used. See Figure 2 for an exmple of
how this might look.
Next, evaluate each EDC system against the requirements
that it will need to complete. Rank the systems based on how
well your requirements are met, putting more weight on more
important factors. Put some intangibles in here such as corporate culture fit; those “soft” types of considerations can be
added in at this point to assist with the final decision.
The last step in evaluating EDC platforms is to complete
a detailed company stability assessment of the final chosen
vendors. Review the EDC platform provider, its market capitalisation, price earnings ratio, profitability (profit margin and
operating margin), management effectiveness (ROI, ROE),
and review financial statements (balance sheet, income statement, and cash flow). This step is often overlooked, but it
is worth the time to do a detailed financial review, and the
majority of this information can be gleaned easily from a
public finance website. See Figure 3 for an example of this.
The goal of the financial review is to ensure the company
is stable and financially solvent. After reviewing the company
financials, it should be clear which companies are more likely
to invest, develop and expand their EDC solutions. Larger
financials aren’t always the answer, but the trending should be
positive. Consider if the company has the money to continue
to invest into its product and how many products they make.
Also, consider the brand name and reputation of the company;
will new clients be attracted as a result of the acquisition? Is
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© Informa UK Ltd – April 2012
Figure 3 Financial review
Vendor 1
Vendor 2
Vendor 1
Vendor 2
Market Cap (intraday)5:
381.57M
638.99M
Total Cash (mrq):
86.90M
112.50M
Enterprise Value (1-Feb-10)3:
297.22M
520.44M
Total Cash Per Share (mrq):
3.819
2.599
Trailing P/E (ttm, intraday):
142.12
60.49
Total Debt (mrq):
4.59M
0
Forward P/E (fye 31-Dec-10) 1:
21.5
23.43
Total Debt/Equity (mrq):
N/A
N/A
PEG Ratio (5 yr expected):
1.1
1.34
Current Ratio (mrq):
1.136
1.661
Price/Sales (ttm):
2.81
3.12
Book Value Per Share (mrq):
0.745
6.3
Price/Book (mrq):
22.39
2.32
Cash Flow Statement
Enterprise Value/Revenue (ttm)3:
2.2
2.57
Operating Cash Flow (ttm):
25.70M
32.75M
Enterprise Value/EBITDA (ttm)3:
17.419
17.546
Levered Free Cash Flow (ttm):
55.60M
-14.54M
VALUATION MEASURES
Balance Sheet
FINANCIAL HIGHLIGHTS
TRADING INFORMATION
Profitability
Stock Price History
Profit Margin (ttm):
1.55%
5.34%
52-Week High (03-Aug-09)3:
19.73
17.09
Operating Margin (ttm):
5.19%
7.17%
52-Week Low (28-Sep-09)3:
14.53
9.89
50-Day Moving Average3:
15.74
15.31
200-Day Moving Average3:
16.28
14.51
Average Volume (3 month)3:
248,571
308,229
Management Effectiveness
Return on Assets (ttm):
4.19%
2.41%
Return on Equity (ttm):
195.52%
4.43%
Return on Equity (ttm):
195.52%
4.43%
Income Statement
Share Statistics
Revenue (ttm):
135.28M
202.76M
Average Volume (10 day)3:
205,044
379,822
Revenue Per Share (ttm):
12.102
4.765
Shares Outstanding5:
22.75M
43.29M
Qtrly Revenue Growth (yoy):
26.60%
23.60%
Float:
14.17M
41.21M
Gross Profit (ttm):
55.28M
97.24M
% Held by Insiders1:
20.30%
3.71%
EBITDA (ttm):
17.06M
29.66M
% Held by Institutions1:
31.10%
99.60%
Net Income Avl to Common (ttm):
1.73M
10.82M
Shares Short (as of 15-Jan-10)3:
373.12K
1.98M
Diluted EPS (ttm):
0.12
0.24
Short Ratio (as of 15-Jan-10)3:
2.1
11.1
Qtrly Earnings Growth (yoy):
N/A
-47.40%
Short % of Float (as of 15-Jan-10)3:
N/A
4.80%
Qtrly Earnings Growth (yoy):
N/A
-47.40%
Shares Short (prior month)3:
282.55K
2.14M
Source: Synteract
the system used widely enough in the market that you can find
employees with prior system experience?
When completing the final EDC selection, in addition to
considering company metrics and financials, it is necessary to
review technology stack, the layers of components that make
up a business’ software solution, and alignment with internal IT
roadmap. If a business requires centralised data flow then the
EDC system will need to integrate with other business systems
in order to provide centralised reporting and eliminate duplicate
data sources; however, if all that’s required is a standalone EDC
system then that will not matter.
Do not make the final EDC selection within a vacuum.
Consider market conditions and trends at the time. For
example, will the EDC system need to perform on an iPad?
Does it support multiple browsers? Be sure to consider the
momentum of the marketplace prior to the final decision and
anticipate where the marketplace is headed.
With a clear focus on ROI and efficiency gain, it will be
easier to locate the EDC platform that gives a business the
© Informa UK Ltd – April 2012
most benefits and functions. Anticipate spending anywhere
from three to six months evaluating an EDC system, possibly
even longer for larger systems. Consider the pros and cons of
bringing an EDC system in-house versus cloud-based hosting
(SaaS). Test EDC systems in a hosted “sand box” environment,
and encourage end-users and stakeholders to get involved.
Lastly, ask to check reference accounts and evaluate what other
clients’ experiences have been with the product. n
Toby Odenheim,
Director, IT Services,
Synteract,
Tel: +1 760 268 8092
Email: [email protected]
www.synteract.com
Synteract is a full-service contract research organization with
a successful 17-year track record supporting biotechnology,
medical device and pharmaceutical companies across
Phases I-IV clinical development.
www.scripclinicalresearch.com
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