CHAPEL HILL, NC, UNITED STATES - Apr 23, 2014 - Rho, a contract
research organization (CRO) focused on bringing new products to
market through a full range of product development services,
describes four benefits of using a non-regional monitoring strategy
for clinical trials versus a traditional regional model.
"If you ask most CROs and Sponsor companies how clinical
monitors are assigned to study sites, the answer is typically
geography," said Tara Gladwell, vice president of Operations for
Rho. "One viable alternative to the traditional regional
model is a non-regional monitoring strategy where CRAs work in a
central location and are assigned to studies based on therapeutic
expertise and availability, instead of geography."
The main benefit of the traditional regional model is a
potential reduction in travel time and associated costs, since
clinical monitors (CRAs) live and work in the same region as the
study sites. While travel-related cost savings can be compelling,
it's important to consider the entire picture. In a traditional
regional model, CRAs are often assigned to multiple studies at any
given time, are required to handle grueling travel schedules with
multiple site visits a week and are forced to cope with the
challenges of working remotely. As a result, job satisfaction,
monitoring quality and project team cohesiveness can suffer.
In a non-regional model, site assignments are made with
efficiency in mind. There are many potential benefits to this
alternative model, and Rho has provided four of the most
significant ones below:
1. Increased monitoring efficiency and
In a non-regional monitoring model, CRAs are assigned to
protocols and sites based on experience, not location, which means
that CRAs can be assigned to fewer protocols simultaneously
(preferably just one protocol). This model allows CRAs to be true
experts on their assigned protocol(s), instead of juggling several
different protocols. Protocol-focused CRAs are able to provide
higher quality monitoring and better attention to their study
sites. This model also reduces the number of CRAs that are needed
to monitor a study and leaves the project team with a smaller, more
focused team, which reduces administrative costs and leads to a
more cohesive team.
2. Reduces CRA burnout
One of the most reported causes of work-associated stress for
CRAs is the need to juggle multiple protocols, which is a necessity
in the traditional regional model. CRA burnout can have
significant cost and time implications for clinical trials,
negatively affect monitoring quality and efficiency and team
dynamics can suffer. Using the non-regional monitoring model
allows CRAs to focus on fewer priorities, which leads to more
engagement and less burnout.
3. Better Project Team
In a non-regional
monitoring model, CRAs are more fully integrated into the project
team, both logistically (e.g. either working in the same office or
able to easily attend meetings in the office) and functionally
(e.g. being a true expert on one or two projects). This structure
provides a sense of belonging, better team cohesiveness, more
efficient meetings and increased ownership. Overall, this model
contributes to CRA job satisfaction and a greater loyalty to the
company, which often results in better CRA retention rates.
4. Better set up for risk-based
As the industry moves toward risk-based and centralized
monitoring, it will be more critical than ever that CRAs work
closely with the rest of their project team. Specifically, they
will need to have strong relationships and seamless handoffs with
project team members in data management and biostatistics who can
assist with some of the strategies necessary to successfully
implement a risk-based strategy. This type of team integration is
more feasible in a non-regional monitoring model.
"It's clear that the clinical trial monitoring landscape is
changing right now. The FDA's recent issuance of its 'Guidance for
Industry: Oversight of Clinical Investigations-A Risk-Based
Approach to Monitoring,' demonstrates that the industry's
traditional approach to clinical monitoring can and should be
re-configured in favor of more agile, efficient, and creative
strategies," added Gladwell.
A non-regional monitoring model has the potential to increase
the quality and efficiency of monitoring while increasing overall
CRA job satisfaction and project team cohesiveness.
To learn more about Rho, please visit www.rhoworld.com.
Rho, a privately-held, contract research organization (CRO)
located in Chapel Hill, NC, provides a full range of clinical
research services across the entire drug development process. For
more than 25 years, Rho has been a trusted partner to some of the
industry's leading pharmaceutical, biotechnology, and medical
device companies as well as academic and government organizations.
Our commitment to excellence, our innovative technologies, and our
therapeutic expertise accelerate time to market, maximize returns
on investment, and lead to an exceptional customer experience.
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