All CRAs and project
managers are MDs with practical working experience in health care,
many of them with a higher degree of specialisation. They have gained
profound knowledge on country-specific structure of the health care
system and treatment habits. They’ve got the medical background
to understand aims and traps of a clinical trial concept and are able to assess
the importance of events occurring during a patient’s treatment.
All monitors are native speakers in their area of operation and therefore
have a direct access to the source data for verification. With a source
data checklist per patient, kept in English, the sponsor will get
for all countries involved a uniform documentation independent of
the language of the source.
Monitors, project manager and assistants are trained prior to study start with regards to
trial's clinical and medical background, its goals and traps,
handling and organisation, to make the whole team familiar with the
study and to find out necessary organisational adjustments.
Monitors attend regularly in-house training courses, either on a local
basis or by the centralised QA service, and are continuously informed
about new GCP- requirements and modifications.
and quality measures
All reporting from any country or CRA’s location to the
project manager is email-based. Project manager timely evaluates
emailed reports and immediately reacts to problems by appropriate means.
During the clinical trial, project manager, national study co-ordinators and
CRAs exchange the latest medical and organisational experiences on
a regular basis, either in group meetings or phone conferences.
Well-trained monitors, working project- and not area- assigned in
one or few projects only, feeling competent and responsible for their
projects and sites. Their education as physician enables a colleague-like
contact to investigators and an understanding of any medical event
and the measures taken both in patient’s history and during
the course of the study.
experience and staff turnover
Average work experience for CRAs is about 3 years, for senior CRAs/
project managers 5 years. Many staff members have been working for
PHAMOS or in clinical research for more than a decade, some of them
have an experience as investigator.
CRO’s expertise and experience is kept and continuously developed
due to an extraordinary team stability.