ORACLE DATA SHEET
ORACLE HEALTH SCIENCES INFORM
ADVANCED MOLECULAR ANALYTICS
INCORPORATE GENOMIC DATA INTO
CLINICAL R&D
KEY BENEFITS
• Enable more targeted, biomarker-driven
clinical trials
• Improves efficiencies, compressing
study cycle-times and accelerating time
to launch
• Increase data integrity with
comprehensive 21CRF-Part11compliant solution for data management
and analysis
• Improve capturable marker estimate
with correlation analysis between clinical
outcomes and molecular biomarkers
• Clinical and genomic scientists can
utilize public domain data to draw and
compare insights, resulting in faster
identification of targets
• Identify potential risks to trial timelines
and data quality
KEY FEATURES
• Capture and manage molecular data
collected during a clinical trial
• Obtain genomic profiling and analysis
reports
• Integrate with well-established public
domain data for joint analysis with your
own data
• Deployed as software-as-a-service
(SaaS) and fully integrated with Oracle
Health Sciences InForm Cloud Service
Oracle Health Sciences InForm Advanced Molecular Analytics enables life
sciences organizations to incorporate genomic data into clinical R&D, enabling
more targeted, biomarker-driven clinical trials to optimize trial outcomes and
increase efficiency. The solution extends the capabilities of Oracle Health
Sciences InForm, the industry-leading clinical data capture and management
solution to effectively collect, store and analyze genomic data in clinical trials.
Pressing Need for Managing Biomarker Data In Clinical Trials
As the industry moves aggressively forward to expand the effective application of
personalized medicine, biomarkers are becoming a key component of clinical development
programs. The use of prospective genomic testing can optimize patient inclusion into
clinical trials, ensuring enrollment of patients that have the best chance of demonstrating a
positive therapeutic effect.
Oracle Health Sciences InForm Advanced Molecular Analytics (AMA) is the first
commercially available cloud-delivery solution to incorporate genomics into the clinical data
capture and management process. The solution is integrated with Oracle Health Sciences
InForm EDC platform, letting clinical researchers effectively capture, aggregate and analyze
molecular data along with clinical data, providing the information needed to identify new
predictive biomarkers.
Oracle Health Sciences InForm AMA facilitates the prospective dynamic randomization of
patients with or without “omics” signatures into respective treatment arms to optimize study
conduct. Leveraging this seamless process enables improved trial efficiency by reducing the
sample sizes and potentially the treatment duration required to demonstrate statistical and
clinical outcomes. The solution leverages proven technology from the Oracle Health Sciences
cloud-based Translation Research Center to deliver the first “molecular-aware” clinical data
capture and management solution.
Oracle Health Sciences InForm AMA helps life sciences organizations to:
•
Stratify patients and reduce research and development costs and time by leveraging
targeted drug development approaches and decreasing study size and length. The
solution also helps researchers explore synergistic programs through post-trial,
cross-study analysis with combined molecular and clinical data.
•
Reduce or eliminate the difficult manual methods to collect and integrate data into a
single database for prospective analysis and faster decision-making. With InForm
Advanced Molecular Analytics, researchers have consolidated access to both
clinical and genomic data for numerous purposes such as submission or the design
of more exploratory translational research studies.
•
Create competitive clinical differentiation messages for new drugs in highly
competitive markets where comparative effectiveness, outcomes, clinical utility and
cost-effectiveness are critical factors to ensure commercial success.
• Secure, role-based access control,
encryption, and auditing
ORACLE DATA SHEET
•
Enable clinical researchers to study patient genomic profiles, analyze differences
and compare molecular data against common large public domain data sets,
increasing statistical power.
InForm Advanced Molecular Analytics is deployed as software-as-a-service (SaaS) and is
fully integrated with the Oracle Health Sciences InForm Cloud Service. As a comprehensive
and commercially available SaaS solution, life sciences organizations avoid the cost and time
associated with building and maintaining custom solutions.
Define a Better Outcome Measure for a Trial Endpoint
Through the ability to integrate data from multiple sources, including clinical outcomes data
and molecular biomarker data, Oracle Health Sciences InForm AMA lets you analyze the
correlation between efficacy and safety data with patient-specific molecular data. As a result,
these findings can be used as inputs to an adaptive design trial or refine the achievable trial
endpoint – thus optimizing the design of the next study. Overall, these efforts enhance data
analyses and enable better decisions, strengthening the evidence for regulatory approval.
Figure 1. Oracle Health Sciences InForm Advanced Molecular Analytics lets you analyze the correlation between efficacy and
safety data with patient-specific molecular data to optimize study design and strengthen the evidence for regulatory approval.
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ORACLE DATA SHEET
Figure 2. Clinicians and scientists can plan for the next study protocol based on biomarkers identified in a patient
cohort with similar outcomes to a treatment. As just one example, with a few clicks at the user interface, clinicians
and translational medicine scientists can explore the common variants in the responder group.
Combine Broad and Deep Data Capture and Translational Research Capabilities
Developing targeted therapies that work for individuals with a specific genetic signature
requires identification of carefully selected cohorts. This helps researchers discover therapies
that will be most effective with the fewest adverse events. InForm AMA lets scientists
compare patient genomic profiles and analyze their differences with a simple user interface.
You can quickly generate a variety of prebuilt demographic, clinical and genomic reports
based on a custom cohort to conduct analysis and research into relevant features.
Figure 3. The ability to collect, manage, and view molecular data with Oracle Health Sciences InForm Advanced
Molecular Analytics allows scientists and researchers to effectively capture patients’ clinical and genomic profiles.
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ORACLE DATA SHEET
Figure 4. Patient details can be viewed through configurable tables, timeline views and graphical reporting to
obtain a better view of the selected patient cohort, including multiple demographic reports such as age, race,
gender distribution of the cohort, and a composite of age and gender distribution.
Rapidly Identify Subjects with Similar Characteristics
Stratifying patient populations is not a simple task. Cohort identification queries do not follow
a set pattern. Researchers need the flexibility to select from hundreds or even thousands of
different criteria to correctly filter results.
Oracle Health Sciences InForm AMA enables researchers and clinicians to be self-sufficient
in identifying study subjects with similar clinical and omics attributes, reducing the burden on
the IT group. Researchers can iterate using dynamic, ad hoc queries to find the desired patient
groups. The solution also supports drilling down to individual-subject–level detail, with the
resulting queries able to be saved and run again as populations change.
Figure 5. The ability to collect, manage, and view molecular data with Oracle Health Sciences InForm
Advanced Molecular Analytics allows clinicians and translational scientists to stratify patients with
combinations of clinical and genomic criteria in an integrated fashion.
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ORACLE DATA SHEET
Conduct Molecular Searches and Get Visual Results
Oracle Health Sciences InForm Advanced Molecular Analytics enables researchers to run
gene-centric queries. It provides state-of-the-art molecular visualizations displaying holistic
views of multiple omics data modalities stored in the cross-platform Oracle Health Sciences
Omics Data Bank. This integrated view is the foundation for systems-biology–based
approaches to further the molecular understanding of disease leading to new drug targets.
Scalability to Answer Big Data Challenges from Small to Mega Trials
When defining cohorts, large amounts of clinical information must be analyzed and distilled
to drive decisions. Omics data adds even more information that can be managed and analyzed
in the pursuit of biomarkers.
The Oracle Health Sciences InForm EDC platform has effectively managed Phase I trials as
well as many of the largest mega trials in the world, featuring thousands of sites and tens of
thousands of subjects. InForm AMA offers the flexibility to support small trials with a
smaller gene panel, as well as integrating thousands of trials with hundreds of thousands of
whole genome sequences in a single query – letting you scale easily as your needs for
genotype/phenotype analysis expand.
Why Oracle Health Sciences
Backed by the resources of a Global 500 company, Oracle Health Sciences provides you with
the industry’s most comprehensive set of software solutions addressing every aspect of the
health value chain from discovery to care delivery. With thousands of professionals in offices
throughout North America, EMEA, and Asia, Oracle Health Sciences offers unmatched
resources to enable your organization’s goals today and in the future.
Contact Us
For more information about Oracle Health Sciences InForm Advanced Molecular Analytics visit oracle.com, e-mail
[email protected], or call +1.800.633.0643 to speak to an Oracle representative.
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