CLINERION

Accelerate Your Clinical Trials with Systematic Risk Management

Authors:
AlphaMD

Clinerion

Kris Srinivasan
CEO

Randy Ramin-Wright
Head of Quality Risk Management

James Wang
Sr. Director Product Development

Klaudia Keller
Quality Risk / Business Systems Analyst

Introduction
Risk management is an effective means to ensure that corporate goals are reached on time and
within budget. This has been demonstrated throughout the pharmaceutical industry. In this white
paper we will provide an overview of what our risk management approach is and how it protects
and promotes patient safety and data integrity the two primary objectives of clinical trials. We
will also highlight the utility of leveraging standard risk analysis methodologies and data driven
risk management technology to ensure maximum benefit of the approach.

Unparalleled Partnership
Everyone has a responsibility when it comes to
managing risk and it is usually a team effort that
gets the best results! In line with this, our companies
have decided to combine their expertise in the form
of a partnership to provide risk management
solutions. We have developed a service offering
for managing clinical trial risks, including but not
limited to Risk-based monitoring. The collaborative
partnership between AlphaMD and Clinerion
provides the pharmaceutical industry with an
unparalleled clinical trial risk management solution
by utilizing AlphaMDs industry experts that
specialize in engineering risk management solutions
while leveraging Clinerions proprietary delivery of
their clinical quality risk management (QRM)
software and service solutions.

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What can risk management do for

your clinical trial?

Overview of what risk management is

and how it helps clinical trials
Risk management is the process of
identifying, addressing, prioritizing, and
eliminating potential sources of failure to
achieve
objectives.
Applying
risk
management means being proactive,
preventive, predictive and preemptive. Risk
management asks the question, What if?
and looks at likelihood and consequences to
determine which of the what-ifs are
significant and need to be addressed.
With the emergence of risk-based
monitoring studies, risk management has
taken on a crucial role within a clinical study.
As the industry shifts more towards the
practice of remote and centralized
monitoring, it is crucial now more than ever to
ensure patient safety and data integrity
throughout studies that are shifting toward
the idea of risk-based monitoring. Therefore,
proactive identification of risks and how they
are to be controlled will lead to higher
efficiency, lower costs and increased quality
when conducting clinical trials specifically
expressed in reduced monitoring costs and
fewer warning letters.
Impact of performing risk assessments
Every day we mitigate risks in our daily lives.
Certain risk control measures are second

nature to our existence. Risk assessments are

performed to identify when and where risks
may occur (within a clinical study) and to
build risk controls into the process to
proactively minimize risks, and to plan for
actively mitigating them when they arise.
How will a risk assessment impact a clinical
study?
When risk assessment is applied to clinical
studies, our collective goal is to enhance
human subject safety and data integrity by
leveraging AlphaMDs expertise of risk
management and Clinerions expert
software solutions for clinical trial related
services. This will have a positive impact on
study planning and operations along with
building quality into a clinical study.
We will demonstrate that performing only
generic out-of-the-box risk assessments is not
a robust enough process to effectively plan
for your study. However, that does not mean
that risk assessment must be expensive or
time consuming. Our unique offering is a
tailored service that no other vendor can
offer you as we build a comprehensive and
customized risk assessment into a risk
management technology platform that
utilizes engineering best practices and Six
Sigma expertise.

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Systematic Risk Management

Process
Figure 1
Our team takes a systematic
approach specifically tailored to
our clients to produce a strategic
risk management process as
depicted in Figure 1.
By customizing a risk assessment
specific to your study, our team is
capable of integrating tailored
risk controls that pin-point to both
fixed and variable risks that were
identified by the risk assessment
findings. Those findings are
reviewed by a cross-functional
team, then integrated into the
centralized Quality Risk
Management System, tested, and
then deployed for operational use.

Risk Management Process Outputs

The output of our risk management process provides confidence to our clients, defensible to
regulatory agencies, that a rigorous process has been put in place for managing human subject
safety and data integrity related risks within any given study.
To begin our risk management process, an initial mapping and analysis of the current processes is
required to systematically conduct a rigorous risk assessment.
The first process output is a list of all identified risks along with who is responsible, and where within
the process they may occur. This list will also be sorted to depict a view that prioritizes the risks
based on a calculation of severity, occurrence, and detectability of the risk.

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The next output developed is the Process
Optimization Map which displays the efficient
means for managing risks before, during, and
after the study. In turn it will help us to focus on the
most important risks.
Our attention and resources will then be targeted
to those higher priority risks where our tailored risk
controls and specifications (interventions, risk
indicators/key risk indicators, and their calculated
thresholds) become a key component of planning
risk management actions when addressing realtime study risk.
Testing the feasibility and effectiveness of the risk
controls ensures that risk control reports are
reliable and appropriate actions to be taken are
clear. Lastly, implementation of risk control
measures into the Quality Risk Management
System will enable the study team to identify the
risks in real-time in order to take timely and
appropriate action.
Continuous Risk Management
Our process does not leave our clients with a set
it and forget it mentality or offering. We keep
continuous quality improvement in mind from the
very start of our process when we engage our
clients. Our proactive approach to risk
identification and risk control do not end at the
initial risk assessment. Throughout a study, we
regularly conduct interim risk reviews and
assessments in order to measure the effectiveness
and efficiency of the initial risk assessment to
continually adapt to the current environment of the
study. The Quality Risk Management System
periodically computes risk metrics, creates risk
mitigation tasks and generates trending reports
that facilitate the tracking and control of risks and
thereby promote continuous quality improvement
(CQI) of clinical trials.

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Figure 2

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How CQI efforts are reusable for future studies
We not only apply our CQI efforts to the study at hand, we also reapply risk assessment results to
a clients future studies. By continuing the systematic approach to our risk assessment, we revisit the
findings and results to begin building a database of all risks and risk controls for all of our clients.
Our database of risks and risk controls leads to a more predictive analysis by categorizing these
risks and risk controls into common therapeutic areas, routes of administration, drug classes, etc.

How this helps business efficiency and process optimization

The systematic risk management process that helps feed the Quality Risk Management System
enables Sponsors to anticipate and proactively address potential issues before they occur. The
business case for this offering is two-fold: cost savings and time savings.
Cost savings will occur for CROs in the form of minimizing the on-site time needed for clinical
research monitoring resources and the need to randomly deploy these costly assets. By proactively
identifying the high-risk sites or investigators, resources can be properly allocated and deployed
for maximum efficiency and effectiveness.
Time savings will occur in the form of minimizing IRB review time and the need for late protocol
amendments that delay and/or extend clinical trials.

Figure 3

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Conclusion
The current landscape of clinical trials has changed significantly over the past 5-7 years in that
more and more molecules are being tested within a shorter amount of time due to the evolving
nature of the pharmaceutical industry. The number of new diagnoses is increasing exponentially
and the demand to help manage or cure disease is just as high. In addition, the need to manage
costs and be more efficient with resources within the pharmaceutical and healthcare industries has
become more prevalent. In order to help manage cost and resources, systematic risk assessments
and quality risk management systems are the key drivers to achieving success. The financial and
airline industries have utilized these techniques for many years and now it is time for the
pharmaceutical and healthcare industries to follow suit.
The Quality Risk Management system that can be informed by a systematic risk assessment allows
for effective decision making throughout the product lifecycle from inception to delivery. Our
partnership and services provide a comprehensive solution to the current industry demand of
performing clinical trials and getting a product to market in a faster, better and cheaper fashion.

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References
1. FDA. "Guidance for Industry, Oversight of Clinical Investigations--A Risk-Based Approach to
Monitoring." Http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf. N.p., 2013.
Web.
2. "Position Paper: Risk-Based Monitoring Methodology."
Http://www.transceleratebiopharmainc.com/wp-content/uploads/2013/10/TransCelerate-RBMPosition-Paper-FINAL-30MAY2013.pdf. N.p., 30 May 2013. Web.

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