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
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
investigators, site coordinators and site personnel. We are dedicated to obtaining the highest quality data for your
Clinical Trial Monitoring is a mixed bag of activities. The
to perform almost all the managerial activities and to perform these
the monitor should be SMART. The monitor’s role requires him/her to be
S = Spokesperson
M = Manager
A = Auditor
R = Reporter
T = Trainer
To become a SMART monitor one needs several special skills:
good interpersonal relationship, eye for detail, communication,
focus, time management, adherence to commitments, problem solving
adaptability to changing environment.
The monitor’s job is not easy to deliver, since it is more art than
more skill than luck, and more experience-driven than
Our S.M.A.R.T. staff performs the following services:
- Identification and
assessment of Principal Investigators
- Facilitation of Study
qualification, initiation, and
- Regulatory document review and
- 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
- Data query
- Facilitation of communications
between project team, sites and monitors in field.
and managing sites to ensure protocol and GCP adherence.