Phase
II-IV Clinical Trials:
Clinical Trial Management and Monitoring
Quality Assurance (QA)
QA Personnel:
The hallmark of the RCRS QA team is
international training and experience in clinical
research, with a mandate to ensure compliance
to international standards, ethics and GCP.
The team focuses more on preventive than corrective
actions to minimize issues that may arise from
non-compliance. Our staff is experienced in
Phase I to IV studies in drugs, devices and
biologicals for both innovator and generic products
and strives to continually improve internal
systems to exceed sponsor expectations. The
team members contribute in an advisory capacity
to the Indian Society for Clinical Research
(ISCR) and the Indian Forum for GCP (InfoGCP)
Services and experience:
The QA team has been providing study audit services
to its existing clients with the goal being
to avoid regulatory deficiencies. Our team has
wide experience of working at the site, sponsor
and CRO environments and thus has a high understanding
of the local cultural intricacies in the various
countries and regions we serve. Advice from
the Regulatory team is an added feature of the
services provided by the QA team to its clients.
Our auditors have an eye for detail, capabilities
for re-construction of study events and gap
identification with regard to non-compliance
to SOP, GCP and applicable regulations. RCRS
lists its audit observations in confidential
reports which are provided to the sponsor along
with advice for immediate corrective action
and systems improvement. Corrective Action Plans
are reviewed for adequacy and evidence prior
to closing audit findings. Audit observations
are presented to sponsors by classifying them
into minor, major and critical findings with
specified timelines for reporting each of these
classifications.
The following services are provided by the QA
team:
Clinical Investigator
Site Audits
Sponsor Audits
Systems Audits
Central Laboratory Audits
Clinical Trial Supply
Audits
Adverse Event Reporting
System Audits
Computer Systems Validation
Audits
Database and Data Management
audits
GLP Audits
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