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Bringing partnership principles to

site relationships
At INCResearch, we believe forging strong site relationships
is key to ensuring study success and, ultimately, helping you
achieve the best results. To build such strategic partnerships,
we foster a collaborative approach to activities and deliverables.
We also work closely with both you and our sites to develop
a common understanding of expectations and standardize
processes to improve cycle times and promote shared success.
Put simply, well seamlessly integrate our team and sites into
your clinical development project to create efciencies through
close collaboration at every stage.
Working with the strongest sites
A high proportion of clinical study sites fail to meet their
enrollment targets. This leads to signicant delays, costing
pharmaceutical companies millions of dollars every year.
So ensuring sites are able and motivated to meet these
targets is vital to ensuring study success.
Our Investigator Services team is highly experienced in
conducting feasibility and site identication analyses.
Conducted prior to start-up, these help us understand a sites
capabilities and motivations so we can identify where in the
world your study will recruit most effectively. This allows us
to plan for contingencies and maximize opportunities in our
site network.
Adding value through repeat engagements
Experience from repeat engagements is essential when
developing a robust feasibility analysis. Thats why our
dedicated Informatics team facilitates rapid information
sharing to identify trends from similar scenarios and provide
insights on potential recruitment challenges, regulatory issues
and timelines.
We store our investigator data centrally in TrialMD an
investigator database updated upon each repeat engagement.
Data from TrialMD is combined with a technology-enhanced
approach to drastically reduce the time it takes to complete
condential disclosure agreements and initiate the sites
partnership with a new sponsor a less cumbersome and
more efcient method.
However, although the knowledge held by sites is of enormous
value, we know providing the information we need places
a heavy workload on staff. So to reduce this burden and
encourage lasting relationships, we leverage existing data when
possible, constantly rene our communication processes and
promote tools such as self-populating feasibility questionnaires.
Helping sites bring life-enhancing
products to market
Preview INCResearchs capabilities
Four specialized functional teams sit within our
global Site Start-Up (SSU) business unit:
Investigator Services
Study feasibility and key site identication through
our proprietary informatics interface, TrialMD
Site Activation and Regulatory
Contract template development, informed
consent review/negotiation and ethics committee
management
Site Contract Management
Electronic trial master le (eTMF) and global shared-
service hub management with regional exibility and
real-time clinical records access
Patient Recruitment and Retention
Robust patient access strategies ensure motivated
sites and milestone-driven recruitment drives

Being ranked as the #1 CRO to work with in CenterWatchs 2013 Global Site
Survey underlines our commitment to developing and nurturing deep site
relationships partnerships that ensure rapid study start-up, smooth study
conduct and consistently excellent results.

Todd Esporas
Vice President, Site Start-Up and Regulatory, INCResearch
Site
Relationships
A great team for a great start
Site activation is a complex process requiring high levels of
expertise that takes up a substantial proportion of a studys
enrollment time. So its vital to accelerate this process using
expert insights and begin recruitment earlier. Our specialized
SSU teams are highly experienced in site contract initialization
and management (e.g., essential document collection, country-
level regulatory submissions and eTMF management). They
also are able to address individual site issues directly, removing
lengthy administrative processes.
A relationship management representative supports each
team, whose aim is to build deep relationships with core
sites. Working closely with you, these specialists will gather
in-depth knowledge of a sites therapeutic focus, administrative
processes, review board schedules and key contacts. They also
will assess any areas of concern for individual sites (e.g., local
regulatory or institutional requirements), establish the best
method of collaboration, negotiate master service agreements
and pre-negotiate indemnication/Informed Consent Forms on
your behalf.
Combined with our metrics-driven processes, all this will
ensure your study starts faster, runs smoother and ends sooner
while generating greater efciencies that improve quality and
reduce costs.
Helping sites support patient enrollment
No product can be developed without patients. However,
enrollment is the longest and most costly stage of clinical
development and most studies fail to meet their recruitment
targets. A sound recruitment strategy structured around solid
site relationships can help avoid this.
At INCResearch, our deep understanding of patient
populations and their motivations means we know where to
nd them and how to prevent dropouts. This knowledge stems
from a combination of historical data and comprehensive
patient demographic reviews. This information provides our
sites with unrivalled patient-centric data sets and allows us to
develop a wide range of materials to support staff and patients
alike (e.g., pre-populated screening and recruitment kits).
Site support at every stage is also paramount when it
comes to recruitment. Thats why weve developed a Global
Patient Recruitment Pre-Screening Portal to allow study
teams to communicate with sites, track progress and monitor
target milestones.
This also allows us to share best practice and use our highest-
performing sites to mentor sites that may be struggling to meet
their targets. Such understanding and support fosters loyalty,
trust and, ultimately, success.
For more information
on how INCResearch will help you foster enviable site
relationships, please contact us at info@incresearch.com
or at one of the numbers below:
North America
Raleigh, NC, United States. Tel: +1 919 876 9300
Europe/Middle East/Africa
Camberley, United Kingdom. Tel: +44 1276 481000
Asia/Pacic
Port Adelaide, Australia. Tel: +61 8 7202 1500
Beijing, China. Tel: +86 10 5809 2300
Gurgaon, India. Tel: +91 124 464 2400
Latin America
Mexico City, Mexico. Tel: +52 55 2169 0300
Corporate Headquarters
3201 Beechleaf Court, Suite 600, Raleigh, NC 27604-1547, United States
Tel: +1 919 876 9300Email: info@incresearch.comwww.incresearch.com C
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A unique solution to a unique challenge
Challenge: An ongoing cancer study requires the
recruitment of patients who have experienced a
conrmed blood clot within the past 72 hours.
This extraordinarily tight timeline means identifying
high-risk patients in advance will be vital to maximize
recruitment opportunities.
Solution: Were developing a study portal that will
provide a central communication platform and allow
the study team to easily communicate with sites.
A pre-screening facility will allow for the rapid
evaluation of patients, while a screening failure log
will enable speedy collation and monitoring. Integrating
this platform with IVRS will also facilitate progress
tracking by automatically importing new randomized
patient data daily and comparing these totals against
projected targets. Additionally, an interactive map will
highlight performance, while a reporting page will allow
CRA and study staff to lter data and monitor progress.
Benets: In addition to the bespoke functionality,
the portal will provide a central repository for study
resources. This will provide ease of access and ensure
the right people see the right information.

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