Success in clinical development is key to
the long-term success of pharmaceutical and biotechnology companies.
Today, however, the size and complexity of clinical programs are
increasing disproportionately faster than available resources. To
succeed, clinical organizations must find new, more efficient ways of
operating.
Our clients are clinical development leaders that are seeking a partner to help
improve the efficiency and effectiveness of their operations. They
need experts to help drive change initiatives so that their key staff can remain
focused on producing clinical results. As a result, they have developed a keen
awareness of what actually works and what doesn’t.
Panaceum Consulting, LLC is an expert in a broad range of therapeutic areas. Our CRA-s
understand your study and the importance of a professional
relationship with
investigators, site coordinators and site personnel. We are dedicated to obtaining the highest quality data for your
study.
Clinical Trial Monitoring is a mixed bag of activities. The
monitor has
to perform almost all the managerial activities and to perform these
activities
the monitor should be SMART. The monitor’s role requires him/her to be
a:
S = Spokesperson
M = Manager
A = Auditor
R = Reporter
T = Trainer
To become a SMART monitor one needs several special skills:
initiative, confidence,
good interpersonal relationship, eye for detail, communication,
flexibility,
focus, time management, adherence to commitments, problem solving
ability, and
adaptability to changing environment.
The monitor’s job is not easy to deliver, since it is more art than
science,
more skill than luck, and more experience-driven than
textbook-learned.
Our S.M.A.R.T. staff performs the following services:
- Identification and
assessment of Principal Investigators
- Facilitation of Study
Start-Up.
- Site
qualification, initiation, and
closeout.
- Regulatory document review and
collection.
- Monitoring clinical
research projects to ensure subject safety, adherence to protocol, data
integrity and regulatory compliance.
- Reporting and investigating
serious adverse events.
- Tracking patient enrollment.
- Performing drug
accountability.
- Data query
resolution.
- Facilitation of communications
between project team, sites and monitors in field.
- Educating
and managing sites to ensure protocol and GCP adherence.
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