LIFE SCIENCES I TECHNICAL BULLETIN MARCH 2017

SGS IMPLEMENTS NEW ORACLE ARGUS SAFETY DATABASE

SGS has implemented Oracle Argus as its new in-house safety database. The changing pharmacovigilance
requirements for processing solicited and unsolicited Adverse Events (AE) inspired SGS Pharmacovigilance and
Drug Safety team to seek a new solution for day-to-day case processing and providing customers with effective
pharmacovigilance solutions.

PHARMACOVIGILANCE AND of a given drug. Through the past pharmacovigilance requirements of the
CASE PROCESSING decades, validated safety databases life sciences industries. The system’s
were developed in order to help the advanced database helps to ensure
Pharmacovigilance, also known as pharmaceutical industry and health global regulatory compliance, aid faster
drug safety, is the pharmacological authorities in the process of AE reporting and more informed safety decisions, and
science relating to the collection, and management2. integrate safety and risk management
detection, assessment, monitoring functions.
and prevention of adverse effects with THE SAFETY DATABASE
medicinal products1. Before a medicine is CHALLENGE AT SGS Argus provides retrospective and real-
marketed, extensive clinical studies are time analytics for workflow state, case
conducted. Nevertheless, these studies For many years, SGS was using the lock, and expedited report submission
have limitations due to the strict and Empirica Trace software from the former compliance to improve the quality and
standardized conditions in which they are Phase Forward organisation that was timeliness of safety case processing and
conducted. Some rare adverse effects taken over by Oracle a couple of years reporting. It also reduces operational
or adverse events that occur late are ago. After this acquisition, Oracle finally risks for both clinical trial and post-
often only detected once the medicine is selected Argus Safety as its go-to drug marketed pharmacovigilance data.
marketed. For this reason, it is necessary safety and pharmacovigilance solution
to keep monitoring adverse effects and stopped further development of The system offers many useful features
throughout the life cycle of a medicinal the Empirica Trace system. It was this that drove SGS’s decision to select the
product. decision in combination with new system as the new in-house safety
regulatory requirements that drove database.
AE reporting is most commonly SGS to look for a new solution for its
associated with pharmacovigilance, management of AE reports. MULTI-TENANCY
and consumes a significant amount
of resources. AE reporting involves After a thorough evaluation of the The multi-tenancy feature in Argus
the receipt, triage, data entering, different systems available on the Safety allows multiple clients of SGS to
assessment, distribution, reporting market, Oracle Argus was selected as reside as separate and unique tenants
(if appropriate), and archiving of the preferred system and Perficient in a single database with their data
AE data and documentation. For as the vendor for implementation and completely segregated and restricted to
pharmaceutical companies, AE hosting of the database. authorized users.
reporting is a regulatory requirement
in most countries. AE reporting also ORACLE ARGUS SAFETY Multi-tenancy enables also SGS to
provides data to companies and drug achieve standard configurations (such
Oracle’s Argus Safety is a comprehensive as code lists, workflow steps, and user/
regulatory authorities that play a key
safety database designed specifically new client setup) across clients or to
role in assessing the risk-benefit profile
to address the complex drug safety and

SGS
LIFE SCIENCES I TECHNICAL BULLETIN MARCH 2017

have different configurations for specific ENSURE COMPLIANCE WITH SGS IMPLEMENTATION
clients. SGS can quickly set up new REGULATORY AGENCIES IN
clients based on an existing configuration EVERY REGION As Oracle’s flagship safety system,
and authorize users for the new client. Argus Safety is trusted throughout the
Furthermore, SGS users with greater Oracle Health Sciences safety experts industry for its functionality, reliability,
access can view their work across track regulatory developments worldwide compliance, and ease of use, while
multiple clients, understand their sum to keep Argus current with constantly continued enhancements to Argus
of work across clients, and make better evolving regulations. Meanwhile, Oracle Safety will meet both regulatory and
decisions. safety product strategists sit on both industry’s evolving needs.
ICH and HL7 working groups and work
As a result, SGS can use a single closely with the FDA, EMA, and PMDA In August 2016, the implementation
database for many clients, which to keep products current and help you process started at SGS in collaboration
reduces the amount of hardware easily adapt processes to new regulatory with the Perficient’s expert safety team.
needed for an implementation. Fewer requirements.4 Argus Safety, version 8 with multi-
patches and dictionary upgrades are tenant functionality was successfully
required, which decreases the resources Support for import, export, and tracking implemented based on SGS’s design,
necessary to support an implementation. of ICSRs via the E2B standard helps to configuration, procedures and AE case
ensure cases are reported instantly and management workflow specifications. In
CLOUD SETUP accurately. Moreover, the recent Argus order to guarantee the maximum support
Safety 8.0.1 version implemented at SGS and business continuity to our clients,
Hosting a safety system in a compliant comes with new expedited reports (e.g. SGS deployed the system in Perficient’s5
cloud eliminates the need to purchase ICH E2B(R3)) for the reporting of AEs. regulatory-compliant clinical cloud.
hardware and hire resources to manage
the solution. With increased safety Furthermore the comprehensive, Thanks to this collaboration together
demands, applications are becoming collaborative and user-friendly periodic with Perficient’s expert safety team, we
more complex and more difficult to AE reporting encompassing PSUR, are proud to offer the leading safety and
manage. Through the cloud setup, DSUR and more reduces the time pharmacovigilance system on the market
ongoing support is available through required to produce periodic submissions to our existing and future clients.
the Perficient Help Desk services and while increasing their accuracy.
business continuity is guaranteed for
SGS clients. Most importantly, the cloud
allows SGS to focus their resources on
their core business of AE processing and
management.3

SOURCES
1. The Importance of Pharmacovigilance, WHO, 2002
2. https://en.wikipedia.org/wiki/Pharmacovigilance
3. http://www.perficient.com/insights/guides/2016/enabling-better-safety-decisions-with-oracle-argus-safety
4. http://www.oracle.com/us/industries/oracle-argus-br.pdf
5. http://www.perficient.com/industries/life-sciences

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