1. A Risk Based Approach to Monitoring:
Optimizing Clinical Operations
Addressing Surging Clinical Trial Costs
Why Do Clinical Trials Need Business Analytics?
Optimizing
Developing drugs is an effective than pre-existing Clinical Trial
expensive process, and the products [2]. Moreover, the Operations
cost of clinical trials is rising. expiration of drug patents
It is estimated that bringing a and the introduction of
Companies, such as Annex
drug to market costs $1.2 generics, biosimilars, and Clinical, leverage Business
billion [1]. One reason why the the corresponding Analytics to identify site
underperformance and
FDA: “There is a growing consensus that risk-based
approaches to monitoring, such as focusing on the
most critical data elements, are more likely to
ensure subject protection and overall study quality,
and will permit sponsors to monitor the conduct of
clinical investigations more effectively than routine
visits to all clinical sites and 100% data verification”
cost of clinical trials is rising is regulatory authority
because the number of changes to make the
successful government drug approval process cheaper,
applications has increased in faster, and easier for
the past decade, and it has generics [3] is also
apply resource allocation
become more difficult for contributing towards further models to effectively reduce
companies to demonstrate to market saturation, hence, clinical trial costs, enhance
clinical trial productivity,
regulatory authorities that pushing biopharmaceutical
and improve operational
new drug products are more effectiveness.
[1] http://csdd.tufts.edu/research/research_milestones
[2] http://www.cmaj.ca/content/180/3/277.full
[3] http://www.arthritistoday.org/news/fda-hearing-biosimilars098.php
1

2. enterprises to invest much reimbursing sites for their trial costs, and emphasizes
more in drug development. time. When clinical trials that guidelines will be
become large, particularly in changing to meet a risk-based
Due to the increased
Phase II, Phase III and Phase monitoring approach [4].
awareness around rising
IV studies, where site
clinical trial costs, many “There is a growing consensus
participation increases from
biopharmaceutical companies that risk-based approaches to
100 study sites to sometimes
and CROs are attempting to monitoring, such as focusing on
over 300 study sites,
find breakthrough the most critical data elements,
managing operating costs and
methodologies in are more likely to ensure subject
optimizing operations
implementing clinical trials in
protection and overall study
becomes even more essential
order to reduce costs and
quality, and will permit
because drug development
improve operational
risk increases notably during sponsors to monitor the conduct
effectiveness. However,
these phases. of clinical investigations more
existing technologies and
effectively than routine visits to
processes do not provide the Some clinical trial enterprises
all clinical sites and 100% data
solutions that many clinical have attempted to optimize
verification” [4] .
teams demand. For instance, their monitoring operations
management currently has through reorganization. For Business Analytics could be
access to basic analytical tools instance, some CROs have applied towards managing
that show current clinical trial hired monitors closer to and optimizing resource
progress, but, do not assist strategic study site locations allocation models to support a
with decision-making. in order to cut down on travel risk-based approach towards
costs. Nevertheless, these monitoring.
A Risk-Based Approach to
methods are not enough to
Monitoring: Clinical Trial Are There Solutions?
address skyrocketing clinical
Operational Optimization
trial costs. Some companies, such as
Currently, many clinical Annex Clinical, are offering
The FDA has released a new
teams experience high solutions that assess site
guidance document in August
monitoring costs, which performance from multiple
of 2011 that addresses the
consist of monitor salaries, perspectives in combination
concern of increasing clinical
traveling expenses, and with strategic resource
[4] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf
2

3. allocation modeling advice in device, and CRO companies resources on
order to make a significant enhance their monitoring underperforming sites, and
impact on clinical trial costs. resource allocation modeling less allocation on those that
by identifying exhibit normalized traits.
As a result, these solutions are
underperforming sites, and
poised to help bio-
focusing more of their
pharmaceutical, medical
Annex Clinical is a global leader in clinical trial strategic consulting that offers solutions through
Business Analytics. Annex Clinical merges business, financial, and operational facets with strategic
advice from proven analytical methods and Fortune 100 & 500 industry experience in order to assist
clinical operations teams and management with predicting future outcomes and improving decision-
making effectiveness.
Annex Clinical’s Business Analytics solutions could use to:
 Optimize site management, monitoring & operational activities
 Efficiently and effectively assess clinical trial quality
 Enhance resource allocation modeling
 Forecast trial enrollment completion with confidence ranges
 Enable teams to predict and react to events before they occur
Many Pharmaceutical, Biotech, CRO and Medical Device enterprises leverage analytical information in
order to provide basic study snapshots. Annex Clinical’s solutions go beyond by assisting clinical
operations management and study teams with developing business objectives, analyzing data,
predicting future outcomes, and providing meaningful and useful business advice. Implementing
Annex Clinical's solutions towards clinical trials represents a novel approach towards minimizing
clinical trial costs, mitigating risks, and reducing time.
Contact Annex Clinical Today for a Complimentary Consulting Assessment
Moe Alsumidaie
President & Chief Scientific Officer
Annex Clinical
+1 (415) 830-3908
info@annexclinical.com
3
www.annexclinical.com