Data Management

Best in Class Solutions

At ICON we provide our customers with customisable Data Management solutions that quickly deliver high quality and
meaningful data to help them to make well informed decisions earlier in the trial. This also ensures patient protection and
reliable trial results. Sponsors rely on us for flexibility, quality, and technical expertise in our customised solutions. We offer
consulting, standalone, or full service integrated solutions focused on project success and in line with your study goals.

ICON has been delivering best in class data management Standard Data Management Offerings
solutions, both as part of a full service offering and in
DM Project Management Excellence:
functional relationships for the past 30 years. We leverage
our global capabilities to provide a blend of resources that – Project Management Certification
enables direct onshore/nearshore contact with our client
counterparts, maximising the cost efficiency we can deliver – Technical Project Management
from our offshore operation. – Risk & Mitigation Strategies
– Proactive Project Planning
ICON Partnership Models
– Strategic Communication
We can offer a wide range of customised operating
models to meet industry needs:
Rapid Electronic Data Capture (EDC) Build
– Onshore, Nearshore and Offshore outsourcing
Partnerships Multiple options for EDC systems:
− Singular or blended location models customised - Medidata Rave™
to Sponsor and Trial requirements, such as: - Oracle InForm™
− Optimal timezones to maximize - Veeva CDMS™
Sponsor interaction time
- DataTrak UX EDC™
− Cost containment
− Global Coverage Fully validated clinical database within 8 weeks using:
− Cross-functional Support – Rigorous control and deployment of standards
– Functional Service Providers – Streamlined review and approval process
– Partnerships & Portfolio Management Expertise – Interactive online review meetings and UAT
– Process Improvement Consulting – Full EDC build & Modular Functionality capabilities
– Strategic Collaborations supporting Sponsor
– Oversight of Risk & Data Quality

ICONplc.com/DM
Comprehensive Data Cleaning Strategies
Batch data cleaning processes are employed to ensure
high data currency and quality. Data trend analysis and
data visualisations enhance traditional data query and
review processes.
SDTM Conversion
ICON is a Platinum CDISC member with CDISC Board
representation. We have a large team of SDTM experts
for SDTM mapping on a study or portfolio level. SDTM
data packages are delivered via double-programming
with Enterprise Pinnacle 21 for issue management and
compliance checking.
Legacy data conversions are a key strength of the team
with multiple options across SDTM and ADaM data
conversions available.
LPO to Database Lock target of 21 days
Early planning with cross functional teams enables
us to achieve database lock within a 21 day timeframe.
Identifying site trends and implementing risk mitigation
strategies enables us to keep processes on track.
Batch data cleaning processes support data currency
ensuring no bolus of activity towards database lock.
Cost Competitive Pricing
Leveraging our global capabilities, cross functional
collaboration and creating standard data structures,
we can offer you maximum cost efficiency and shorter
development timelines.
Experience you can trust
One of the key drivers of success in your study is having
an experienced Data Management team.

Applied Innovation

ICONIK:
ICON, a leader in the management of clinical trials
and the development and use of advanced data 1,000
global professionals
analytics, identified the need for a set of data
visualization and analysis tools to support sponsors
and study teams with the review and detection of
medical and safety risk on clinical trials. ICONIK,
our proprietary technology platform, collects real-time
data during the trial process enabling better decision
making and the successful implementation of clinical
trial strategies. 75%
Up to 75% reduction
Data Review Tool: in resource costs

ICON has developed the Data Review Tool (DRT)

which is an in-house Spotfire-powered Data
Management tool developed to enhance the data
review process and improve delivery to customers.
Key features of this tool include a centralised view of
eCRF and external data reconciliation listings, Source
data, Audit History, Filters, and Overview Reports e.g.
Workload and Data Cleaning Reports, In-built Clean
1,300+
EDC studies completed across
Patient Trackers and Clean Visit Trackers. DRT enables a wide range of therapeutic
effective data review management, improve oversight areas and clinical phases
and availability of metrics for data cleanliness and
support data currency.

Robotic Process Automation:

Automation implementation for efficiency in the
following areas:
– Freezing and Locking data in EDC
– Auto-raising queries from the Data Review Tool
– Automated Data Reconciliation
Additional exciting automation projects are in progress
to drive automation and efficiency to the data For more information, please contact:
management process. ICONplc.com/contact

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