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Drug Safety Management
PRA is an industry leader in providing complete Drug Safety Management.
Effective management of drug safety information can save you millions in
development expenses and protect future sales. But with stricter
international regulations, downsizing trends, and the higher quality of
information required, you may find it increasingly difficult to keep up.
That's where PRA can help.
PRA's Drug Safety Services is an industry leader in providing complete
safety services, including processing of individual reports on adverse
events from clinical trials and adverse drug reactions for marketed
products, preparation of individual reports for expedited submission to
health authorities, maintenance of global safety databases, generation of
annual safety updates and periodic safety update reports (in CIOMS II
format), preparation of integrated summaries of safety, design and conduct
of pharmaco-epidemiological studies, and consultation. Our staff is comprised
of physicians, epidemiologists, pharmacists, statisticians, clinical
programmers, clinical data specialists, and research nurses with many
years of experience in drug safety management.
PRA's worldwide services and capabilities include:
Reporting of Serious Adverse Events
PRA has proven processes and systems for managing reports of serious
adverse events (SAEs) in international clinical trials. Our 24-hour-a-day
safety telephone service gives investigators immediate access to a dedicated
medical staff. And our ability to track safety data in either your database
or ours means that your data will be processed consistently and accurately.
Written medical evaluations include narratives, causality assessments,
follow-up information from the investigational sites and recommendations for
reporting to regulatory authorities worldwide. We can submit SAE reports in
an agreed format to you or directly to the regulatory authorities.
Processing and Reporting of Adverse Drug
Reactions (ADRs)
Reports of adverse drug reactions come from many sources, including spontaneous
reports, clinical studies, literature and other databases. For ongoing
post-marketing surveillance, our Drug Safety team can produce AE and ADR
reports individually or in a batchwise manner from Phase IIIB and Phase IV
studies-maintaining the database in either your format or our own. We can
generate country-specific reporting forms, including the correspondence with
the appropriate regulatory authorities, and we interact directly with most
health authorities.
Periodic Safety Update Reports
PRA has written many Periodic Safety Update Reports (PSURs) for products
in different therapeutic areas. Our standard operating procedures (SOPs), which
follow International Conference on Harmonization (ICH) guidelines, provide the guidance we need to prepare complete and
accurate reports. In addition, PRA has the expertise to produce risk-benefit
assessments ready for submission.
Safety and Pharmaco-Epidemiological Studies
PRA's experts can design, conduct, and analyze data from safety and
pharmaco-epidemiological studies. We design studies specifically to address
short- and long-term risks associated with administration of a drug, and to
investigate rare drug reactions in large cohorts of patients. We can
participate directly in or provide support to your data safety monitoring
boards, and we interact with a variety of partners, including sponsors,
health authorities, and other CROs.
Global Database Pooling and Integrated Summaries of
Safety
PRA has extensive experience with integration of numerous databases and
producing integrated summaries of safety. We can convert any format for data
pooling, ensure standardized coding of medical and pharmaceutical terms, and
reconcile your safety and clinical databases. PRA can perform meta-analyses,
including cumulative AE rates and hazard rates, and produce a comprehensive
safety profile for your drug.
Whether you need individual ad-hoc/temporary support or a comprehensive
review of your pharmaco-vigilance system, PRA has the experts you need.
Page last updated:
19 June 2008
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