R&D
based Oracle Remote Data Capture, support major impact across the entire industry. For Oracle, third-party and custom applications.
the need for speed and agility, delivering near example, the US Food and Drug Regulators have also become increasingly
real-time data to both research partners and Administration Amendments Act (FDAAA), keen to see documented evidence of
pharma sponsors regardless of their location. which can require manufacturers to submit a compliance and due diligence without manual
Closer collaborative relationships in the Risk Evaluation and Mitigation Strategy intervention; they’re really looking for system
pharmaceutical industry have, in fact, led to (REMS) when a drug first comes on the controls and limited human intervention
opportunities of a different type for Oracle. market or later, is proving to be hugely when it comes to critical compliance issues.
The company aims to provide its products in influential in this regard. Similar moves are They’re becoming more and more interested
ways so that they can be used or afoot in Europe. One of the biggest in the technology and understanding how it
dispositioned from one customer to another,
developments is the emergence of post- can help to reconstruct events accurately and
enabling organisations to work together more
marketing surveillance commitments attached objectively.
efficiently and effectively. In addition, industry
to any potential approval. Oracle is working to put a lot of that
players may require the same types of basic
information into the application so it can be
information, but a CRO might want to see it
produced on screen or produced in a report
presented in a slightly different format than a
Q. What tools do pharmaceutical
form. In this way, inspectors can be assured
pharmaceutical customer. Evolving industry
manufacturers need to facilitate compliance
that information came from the system and
models are, therefore, influencing the
with these new requirements?
that nobody has adjusted it.
direction of Oracle’s products as we remain
steadfastly focused on meeting the market’s
Pharma companies require tools that enable
needs.
them to effectively track, analyse and report
Q. How has pharma’s relationship with IT
on data, particularly around
providers changed over time? How has
Q.
pharmacovigilance/safety. This type of Oracle responded to this?
What challenges does the trend
information can come from many different
toward globalisation of clinical trials present
sources, including physicians and patients, and As life sciences organisations increasingly rely
to the pharmaceutical industry?
arrive via many different channels. The on IT to enable innovation and faster time to
challenge is to effectively bring the market, collaboration has enhanced, as the
As clinical trial sponsors face demands for
information together in a way that enables stakes are increasingly high for both parties.
larger patient pools, they are increasingly
greater visibility and intelligence. At Oracle, our focus is on the customers’
looking to emerging regions, such as Eastern
needs. As such, we rely heavily on customer
Europe, Asia and Latin America for trial
input to guide product development and
subjects. Conducting global trials presents a
Pharma companies require enhancement. Most of Oracle’s products
unique set of challenges that range from
ethical issues, cultural and language differences,
tools that enable them to
come with their own strategic development
programmes, under which the company
legal and regulatory hurdles and the need to effectively track, analyse and
“partners” with representative customers,
manage multiple CROs.
report on data, particularly
vetting their requirements, and using this
Oracle Remote Data Capture, our pure
HTML application, helps trial sponsors to
around pharmacovigilance/safety
insight to help shape the future direction of
work.
overcome challenges related to geographic
Extensive collaboration between Oracle
location and managing multiple CROs. Our
and its customers has resulted in a greatly
web-based application can be easily and
Oracle is focused on these goals. In
enhanced version of Oracle Remote Data
rapidly deployed anywhere in the world with
combination with its partners, Oracle
Capture that focuses on ease-of-use for trial
an internet connection, collecting data in a
provides comprehensive adverse event
investigators and improved manageability of
structured and consistent manner regardless
tracking and reporting solutions that meet
the system. The hard work paid off with
of location.
increasingly stringent requirements. For
project managers and site investigators
Oracle also has responded to help pharma
example, Oracle Adverse Event Reporting
reporting a marked improvement in usability
companies streamline the management of
System is integrated with DrugLogic Qscan, a
and navigation speed with Oracle Remote
multiple CROs by making it easier for them
leading drug safety data and analytical tool.
Data Capture 4.5.3, which is resulting in faster,
to leverage Oracle Clinical applications, if
The integrated applications equip pharma and
more accurate data entry, thus accelerating
even for a single trial. We have worked with
biotech companies with a powerful lens that
the clinical trial process for our clients.
our partners to create a new subscription
enables them to rapidly analyse patterns in
pricing model for single studies/study
adverse events that may indicate emerging
programmes, aimed at pharma companies’
drug safety risks pre- and post-market,
Q. What lies ahead for Oracle in health
partners, which may include CROs or regional
enabling faster response times and sciences?
services companies. It provides a variety of
streamlined compliance.
deployment and pricing options to meet the
In addition, earlier in 2008, Oracle Oracle will continue to work to deliver
needs of global trials and emerging
introduced Siebel Contact Center Integration integrated end-to-end solutions that help our
companies.
Pack for Oracle Adverse Event Reporting life sciences clients spur innovation and more
System, a solution that streamlines the effectively and efficiently bring products to
Q.
capture, reporting and management of market. We are excited to be on the front
What types of emerging regulatory
adverse events and product complaints while lines of the dramatic transformation taking
challenges keep pharmaceutical executives
improving data integrity. The new integration place today as life sciences, diagnostics and
awake at night? pack offers a closed loop adverse event and
healthcare begin to converge to accelerate
complaint solution. It is delivered as part of insights for better health.
From a regulatory perspective, increased Oracle Application Integration Architecture,
scrutiny on the part of national authorities to which is a comprehensive set of products that
Pete Chan is editor of the Scrip 100.
ensure the safety of new drugs is having a delivers integrated business processes across
www.scripnews.com/supplements Scrip 100
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