Inc Reducing Risk

Reducing Risk
with the Right CRO Partner
Evaluating CROs with Confidence

Therapeutic Foresight. Trusted Results.
SM

Reducing Risk with the Right CRO Partner
Evaluating CROs with Confidence

For drug developers, finding the right patients, investigators and outsourcing
partners is essential. With shareholders demanding improved efficiencies, the
resources, reach and expertise of a contract research organization (CRO) can
expedite the research and development process.

The long-term CRO relationship often travels a rocky path fraught with challenges.
While poor communication and inefficiencies are common pitfalls, the fear of
change is often too daunting. Many organizations simply remain uncomfortably
restrained to the status quo. To make matters worse, there is no CRO Consumer
Reports guide for organizations desiring change.

How can key decision makers objectively evaluate their CRO partner relationships?
What can be done to increase a trial's success?

To meet these challenges, many sponsors are soliciting the services of CROs that
employ process-driven clinical research methods. Designed to help achieve more
predictable costs and actionable results, CROs employing these methods are
speeding the research and development process, while reducing trial risks. This
white paper will examine key challenges faced by drug developers and reveal the
many advantages of process-driven clinical research.

Challenges Deterring Clinical Operations Excellence

Despite the Food and Drug Administration’s (FDA) efforts to improve its review and
Longer clinical trials and approval of new drugs, trials are taking longer. "Many factors are leading to
evolving safety standards
longer clinical times, including a focus on complex diseases and more complicated
create challenges for drug
developers development design protocols. Still in drug development, the race—and rewards—
go to the swiftest and most efficient drug sponsors, those that can deliver safe new
medicines in the shortest time," said Kenneth I. Kaitin, Tufts CSDD director.1

(January 8, 2009). Tufts Center for the Study of Drug Development. New drug development still takes eight years despite faster FDA review.
1

Reducing Risk with the Right CRO Partner Copyright © 2009 INC Research www.incresearch.com

Not only must a drug developer master efficiencies, it needs to address evolving
safety requirements. "The trend at the FDA toward stricter safety standards has
continued unabated and has arguably become even more onerous," found a
Jeffries & Company report.2

Given these trends, selecting the right CRO is even more critical. "The simple truth
is that pharmaceutical companies of all sizes need service providers more than
ever. They need their resources, their global reach and, dare we say it, they need
their clinical development experience and expertise," stated an ISR report.3
However, not all CROs are created equal and many sponsors are questioning their
original criteria for selecting a CRO partner.

• The Transparency Issue

Poor communication is a
Perhaps the biggest challenge working with a CRO is the lack of transparency.
leading cause of Often, sponsor management teams don't have a clear view of a project’s status
dissatisfaction with CROs
at any given point during a trial. "There appears to be a direct correlation between
the project manager's ability to manage the communications process and project
performance," stated project management expert Harold Kerzner, Ph.D.4

Communication breakdowns happen when the CRO's site and sponsor relationships
are weak. Faulty assumptions often prevail, problems remain unseen and unsolved,
milestones go unmet and project budgets evaporate without conclusive results.
Unfortunately, sponsors usually find out too little, too late to salvage the trial.

• The 'C' Word

Change is a risky and often costly proposition for many sponsors. Over time,
Change is a costly
sponsors grow accustomed to the people and processes put in place by existing
proposition for most
biopharms, regardless of CRO vendors—even when milestones fall short. Continuous CRO inefficiencies
CRO inefficiencies
and regular micromanagement are generally accepted routines.

Windley, D. & Evans, T. C. (January 26, 2009). Jeffries & Company. Healthcare: Dissecting the outsourced drug development industry growth drivers.
2

(December 2008). ISR Reports. CRO differentiation.
3

Kerzner, H. (1998). Wiley. Project Management: A Systems Approach to Planning, Scheduling, and Controlling.
4


The old idiom, "the devil you know is better than the devil you don't," often
prevents change from occurring. It takes time and expense to evaluate a new
CRO. New relationships, systems and people often lead to disruptions that can
slow progress.

Many clinical research executives are limited to CROs already sanctioned as
preferred providers—lists to which they had little or no input. "Even though you
have used the same CRO for years, because they are on your preferred provider
list, you have basically entrusted your company's most valuable asset to strangers.
What did you base your decision on? If your biopharmaceutical company is like
most, you gave several CROs a brief synopsis of the compound in development…
and told them to come back in ten working days with a budget, feasibility analysis,
a strategy for patient recruitment and a timeline," stated an ISR report.5 Only time
revealed if these decisions were wise.

• Assessing New CROs

"Buying services from CROs is not like buying a car. There is no JD Power, Kelley
Blue Book or Consumer Reports that biopharmaceutical decision-makers can
reference to get an independent analysis of CRO 'best buys,'" said an ISR report.6
Unfortunately, every CRO claims to be better, faster and cheaper.

There is no simple way
Complicating the issue is the fact that many departments within a sponsor company
to judge the quality of
an unfamiliar CRO, must be involved, including clinical operations, outsourcing, data management,
complicating the
quality assurance, IT, finance and regulatory. While clinical operations executives
selection of a new one
can eliminate a prospective vendor, it is much harder to propose a new one.

However, once the strategic decision is made to
outsource services, a process for selecting
the right CRO must follow. "Let's face it,
CROs are different. Some of them excel
at relationship management, some use

5

Ibid.
6


technology better, some have a global reach that is unmatched and some are
more cost effective," found an ISR report.7

While it's true that all clinical research must follow the same path to approval, the
'how' component is highly variable. Good people, technologies to support them
and procedures that make the path less strenuous will smooth the road to success.

The New Solution: Process-Driven Clinical Research

Designed to eliminate inefficiencies and improve communication, process-driven
Process-driven clinical
research is a combination clinical research is a unique blend of people, processes, technologies and metrics
of people, processes and implemented by CROs to greatly enhance the outcome of clinical trials. Taking
technologies to help
speed drug development proven project management techniques, adding expert consultation and
leveraging the latest technologies, CROs are better able to predict and plan for
the unexpected, maintain open channels of communication and ensure that
sponsors meet their corporate milestones and objectives.

The process-driven approach focuses on the entire stream of study activities from
protocol design to the final study report. A wide range of experts participates to
ensure the best possible outcome. By following proven processes, continually
improving them and applying best practice project management techniques, the
potential for risk is greatly reduced, costs are controlled and results are delivered.

There are four primary phases of process-driven clinical research:
Planning Phase: In this initial phase, the CRO acts as a consultant, reviewing
the sponsor’s goals, objectives and priorities, and helps create the study strategy.
The CRO brings therapeutic experts to the table to evaluate all variables related
to the study. This phase is highly collaborative between the sponsor and CRO to
establish a foundation of trust and confidence.

Implementation Phase: In this second phase, all critical early-stage study activities
take place to accelerate the study outcome. For instance, the responsibilities of

7


the CRO are determined, investigative sites are identified and contacted, and
milestones are determined. A detailed review of risks, timelines and deliverables
is performed. The goal is to approve and finalize all study plans and supporting
documents in a rapid, yet thorough, fashion. Example activities include risk
management planning, a feasibility survey, patient recruitment planning, data
validation and the development of other plans essential to a successful study.

Acceleration Phase: Execution is the heart of the third phase. Momentum builds
with patient recruitment, treatment and monitoring. Trial and data progress is
routinely examined. Risk management contingency actions are implemented to
address problems as they occur. Performance metrics are also regularly examined.
Issues are immediately communicated and rectified to prevent them from becoming
obstacles in the progress of the trial.

Final Phase: This phase begins as soon as the first enrolled patient completes the
trial. Detailed estimates are established for the collection of data to hand off to a
biostatistics team. With trusted data in hand, this step paves the way for refinements
that will make future trials more successful. Proactive plans consider all closeout
activities down to final database lock.
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Implementation Phase Final Phase

Planning Phase Acceleration Phase

Figure 1: There are four primary phases of process-driven clinical research


The Benefits of Process-Driven Clinical Research

Process-driven clinical research provides many significant benefits to drug
developers, including:

– Reduces risks of lost time, poor quality and overspending
Process-driven clinical
research eliminates the
communication challenges – Enables milestones to be achieved on schedule
typically present with most
CROs, greatly enhancing
the efficiencies of trials – Provides access to experts who can foresee potential challenges and
respond appropriately

– Empowers the organization to quickly respond to challenges

– Allows executives to easily convey the status of trials to others

– Maintains flexibility while reducing risk

– Reduces the transition time among various study stages

– Allows concurrent execution of different phases of a study, speeding progress

– Provides actionable data that enables intelligent business decisions that will
impact the company’s bottom line

Brief Example

A sponsor working on a central nervous system (CNS) drug trial had to locate
a difficult-to-find patient population. Using a CRO's existing relationship with
Patient enrollment time was
cut nearly in half using a high-quality investigators, the sponsor had confidence it would achieve its
process-driven clinical enrollment goals. Nevertheless, contingency plans were established that could be
research-based CRO
implemented if enrollment lagged.

After the trial was underway, a risk management trigger point indicated that
enrollment might fall short. The CRO team implemented the contingency plans


with the sponsor’s agreement. As a result, enrollment was completed in 5 months
as opposed to the anticipated 9 months.

The outcome was faster study results and better informed decisions on the
compound’s future. Had the sponsor not worked with a process-driven clinical
research-based CRO, they would not have gained such efficiencies or confidence
in the study results.

How to Evaluate a CRO

When looking for a CRO, When seeking a CRO, consider the
be sure it provides on- following important requirements:
demand experts and can
provide in-depth
benchmarks and In-depth benchmarks and metrics: A
performance metrics
CRO should employ comprehensive metrics
to support its claims. Ask for discrete variables
that track and measure specific sites, monitors, patients, IT and data metrics that
help to prove that the CRO's process can increase the efficiency of a trial.

Risk processes: Look for a company that can support its repeatable process and
can identify and plan for risks to improve the probability of success. This should
include alternative site selection and data management systems.

On-demand experts: Seek a company that can immediately bring experts to the
table to assist with project planning, metrics evaluation and execution.

Data management system–agnostic: The ideal CRO should be able to work with
existing best-of-breed data management systems, eliminating the need to invest
in new systems.

Team quality: To determine if strong chemistry will exist between the CRO and the
sponsor team, assess the proposed trial team’s experience in similar trials.

Communication systems: The best CROs employ the latest technology to
streamline communication.


Full range of services: Advanced CROs can scale to accommodate any biopharm
need, including drafting protocols, designing studies, and performing regulatory
activities and post-approval studies. The CRO should also provide the appropriate
global reach to ensure ready access to targeted patient populations.

Extensive experience: Look for a CRO that has at least a decade of proven trial
experience and is dedicated to the therapeutic areas in need.

Pediatrics expertise: Seek a CRO that has extensive experience with your unique
regulatory requirements and understands how to address the challenges of working
with pediatric patient populations and their caregivers.

The INC Research Advantage

The Trusted Process® by INC Research is a proven metrics-driven methodology
that reduces risk and achieves on-time, on-budget results for clinical trials, meeting
all of the requirements outlined in this paper. Eight of the top ten biopharmaceutical
companies rely on INC Research's Trusted Process.

Eight of the nation's top
ten pharma companies INC Research has managed complex clinical trials for more than 20 years. With
rely on INC Research to a strong therapeutic focus, the company provides scientific experts that anticipate
manage their critical
clinical trials and plan for common pitfalls and develop plans to mitigate them.

INC Research employs experienced, regionally based
professionals in clinical services, data services, late
phase services and therapeutic expertise areas.
Equipped with the knowledge of local languages,
cultures and regulatory requirements, each
location offers a complete range of
customized Phase I - IV clinical
trials and ancillary services.


Providing continuous operational metrics through its Trusted Process, sponsor
teams are aware of progress at all stages of a trial. Results-driven, INC Research
can prove how it consistently helps sponsors achieve their milestones to ensure
they make highly informed and confident decisions.

As measured by its Trusted Process, INC Research customers experience:
– Project enrollment completed on average three weeks ahead of schedule
– Database lock on average over three months ahead of schedule

Let INC Research instill a new sense of confidence in your clinical trials.

For a FREE pressure test on your study plan, email pressuretest@incresearch.com
or for more information call 866-462-7373 or visit
www.incresearch.com/trusted_process/


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