Oracle's Argus Safety is a comprehensive pharmacovigilance platform designed to help life sciences companies ensure global regulatory compliance, enable faster safety decisions through data insights, and integrate safety and risk management functions. With Argus Safety, companies can manage regulatory reporting requirements, obtain visibility into reporting metrics and compliance, and leverage automation and advanced functionality to maximize case processing efficiency and data access for timely review. Argus Safety also provides integrated risk management capabilities and can be seamlessly connected to signal detection systems to proactively manage product safety.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
Pharmacovigilance Training in Oracle Argus Safety Database with ProjectBioMed Informatics
Pharmacovigilance Training in Oracle Argus Safety Database with Project
BioMed Informatics Medwin Hospitals
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.
Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
Web based classroom
One faculty/student
Placement support
Regular/Fast track/Weekend batches
Flexible timings
Training Mode: Skype/Teamviewer
Hands-On Training on the Database
Direct access to Oracle Argus Safety Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
How Oracle Argus Safety 8.x Supports Product Safety NeedsPerficient, Inc.
Pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) have many reasons to use a safety and pharmacovigilance system, such as Oracle's Argus Safety. From capturing adverse events and product complaints to reporting individual case safety reports (ICSRs) to regulatory authorities, a comprehensive solution can address most needs.
In our webinar, Perficient’s Dr. Rodney Lemery, Director of Safety and Pharmacovigilance, reviewed the newest release of Argus Safety. This presentation demonstrated both the basic and complex needs of life sciences companies that can be supported through the implementation or upgrade of the system.
In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
Pharmacovigilance Training in Oracle Argus Safety Database with ProjectBioMed Informatics
Pharmacovigilance Training in Oracle Argus Safety Database with Project
BioMed Informatics Medwin Hospitals
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.
Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
Web based classroom
One faculty/student
Placement support
Regular/Fast track/Weekend batches
Flexible timings
Training Mode: Skype/Teamviewer
Hands-On Training on the Database
Direct access to Oracle Argus Safety Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
How Oracle Argus Safety 8.x Supports Product Safety NeedsPerficient, Inc.
Pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) have many reasons to use a safety and pharmacovigilance system, such as Oracle's Argus Safety. From capturing adverse events and product complaints to reporting individual case safety reports (ICSRs) to regulatory authorities, a comprehensive solution can address most needs.
In our webinar, Perficient’s Dr. Rodney Lemery, Director of Safety and Pharmacovigilance, reviewed the newest release of Argus Safety. This presentation demonstrated both the basic and complex needs of life sciences companies that can be supported through the implementation or upgrade of the system.
Migrating from Oracle AERS to Argus Safety: Reasons for the MovePerficient, Inc.
Not too long ago, Oracle AERS was the most widely-used adverse event report system. However, with the acquisition of Relsys and its safety and pharmacovigilance system in 2009, Argus Safety quickly became the go-to software for most life sciences companies. Its capabilities and comprehensiveness are unmatched.
Companies currently using Oracle AERS have expressed interest in moving to Argus Safety, but want to know more before making the jump. This webinar is meant to do just that – answer your common questions.
Please join Perficient's Dr. Rodney Lemery, director of safety and pharmacovigilance, as he will:
Compare Argus Safety to AERS
Cover the options of effectively migrating to Argus Safety
Using JReview to Analyze Clinical and Pharmacovigilance Data in Disparate Sys...Perficient, Inc.
Sponsors and CROs naturally rely on various clinical and safety systems from a multitude of software vendors. However, continuously accessing disparate sources for the reporting, analysis, and monitoring of data can be a treacherous undertaking, if you don't have a solution that connects to them right out of the box.
That's where JReview comes in. For almost two decades, life sciences companies, research organizations, in addition to the government, have relied on JReview for the comprehensive analysis and monitoring of clinical and pharmacovigilance data.
The analytics solution works with many Oracle Health Sciences applications, including Argus Safety, Oracle AERS, Oracle Clinical (OC), Remote Data Capture (RDC), Thesaurus Management System (TMS), InForm, Life Sciences Data Hub (LSH), and Clinical Development Center (CDC). JReview also works with non-Oracle solutions, such as ARISg, Medidata Rave, and SAS Drug Development.
In this slideshare, you will learn:
The features and benefits of JReview, including the new functionality in v10.0 (e.g., risk-based monitoring analytics reporting on the clinical data itself, etc.)
Benefits of using JReview for:
Reporting and query of your clinical data
Supplying internal and/or external users/sponsors information
Providing a secure way for your internal users and/or sponsor users to access the clinical data
Examples of how customers use JReview with OC/RDC
The implementation process and options
A common goal of life sciences companies is to capture essential adverse event data efficiently. The use of automated systems to document and track this information is proving to be essential in the safety field.
Perficient’s Dr. Rodney Lemery, director of safety and pharmacovigilance, reviewed various features of Oracle’s Argus Safety solution that can assist you in your safety and pharmacovigilance practices.
This training course on Drug Safety and Pharmacovigilance designed to give pharmaceutical and biologic companies operating in the U.S. and EU an understanding of product safety and regulatory compliance.
Minimize the Impact of E2B(R3) on Drug Safety Operations with Argus SafetyPerficient, Inc.
The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonization (ICH) E2B standard, is an essential component of global drug safety and pharmacovigilance operations.
E2B(R3), the latest version of the ISO ICSR standard, presents a number of challenges that need to be addressed before life sciences companies can implement the essential technology and processes required to perform day-to-day activities and comply with the new regulatory guidelines.
Our webinar delivered insight into the impact of the requirements on your drug safety business processes (e.g., CIOMS reporting, Line Listings, PSURS/DSURS, Signal Generation), as well as to how Oracle's Argus Safety can help you meet the E2B(R3) requirements.
Thank you for watching our conference talks and presentations. Great and exciting news at http://www.slideshare.net/sentiance and http://www.sentiance.com
HySynth Biotechnologies’s Pharmacovigilance group provides a range of tailored Pharmacovigilance (PV) and Biovigilance (Hemovigilance) services that can effectively address the needs of biopharmaceutical companies of all sizes.
With people over 10 years of medical, technology and compliance expertise, we are able to provide diligently managed, flexible and cost-effective solutions.
With a full suite of scalable and flexible solutions, we can provide tools and techniques to achieve patient safety, regulatory compliance and long-term strategic advantage.
Our service packages are customized as per requisite of the organization and delivered through a lean operational model which includes, Triage till Medical Review, Case Processing, Case Reporting, Single Case Narrative writing, Aggregate Report writing, Literature Search, etc.
Medical Analysis:
- AE and SAE evaluations
- MedDRA and WHO-DD Coding
- SAE narrative writing
- Causality and Labeling Assessments
- Physician medical review and signal detection
- Literature reviews and summaries
- Updating CCDS and other Core documents
Regulatory Reporting:
- Expedited Reporting: Generation of MedWatch 3500A/CIOMS I forms
- Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
- Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports via E2B and Paper mail.
ICSR Processing:
The processing of individual case safety reports (ICSRs) originating from various sources which includes,
Post-marketing non-solicited/ Spontaneous reports
Clinical Reports
Special reports (Medico-legal, Literature & E2B)
Related Sources
Following established guidelines, data from source documents sent by clients are processed (data entry, MedDRA coding and safety narrative) in to a Drug Safety/Pharmacovigilance database, after a duplicate check.
This involves an initial triage followed by Data processing and a subsequent medical review by a physician. After the review process, the case reports are submitted to the regulatory authorities/business partners.
HySynth’s people have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases.
Argus Screen Shots General Tab - Katalyst HLSKatalyst HLS
Introduction to Argus Screen Shots General Tab - Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Tools used in Pharmacovigilance (Clinical Research & Pharmacovigilance).pptxDureshahwar khan
Let’s take a look at some software used in Pharmacovigilance for the management and reporting of Adverse events.
Some software’s used in pharmacovigilance are:
-Oracle Argus Safety
-ArisG
-Oracle Adverse Event Reporting System (AERS)
-ClinTrace
-PvNET
-repClinical
-Vigilanz Dynamic Monitoring System
-WebVDME Pharmacovigilance Signal detection and Signal management software
-PV works
Covance, in partnership with Oracle, offers a full-service, validated, private cloud, single-tenancy solution based on Argus technology, which enables faster and better safety decisions. This automated and integrated solution allows for easy scientific querying and analytics, which improves the quality and efficiency of safety operations. It also enhances compliance with E2B exchange for expedited and periodic reporting, allowing the organization to conduct global case processing, which can scale to tens of thousands of annual cases.
Việc duy trì kiểm soát các điều kiện môi trường trong các phòng thí nghiệm hoặc phòng sạch được quản lý chặt chẽ để tuân thủ các tiêu chuẩn GMP. Tuy nhiên việc này phức tạp và tốn thời gian. Hướng dẫn này đưa ra một số khía cạnh quan trọng cần xem xét để giảm thiểu rủi ro và duy trì sự tuân thủ trong phòng thí nghiệm hoặc phòng sạch.
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Life science companies struggle to receive and manage product safety related information through their safety email inbox. The lack of audited tracking and the inability to control the entire intake process present risks to safety departments. Most often, safety email inboxes are described as "black holes" where all information comes in but is difficult to manage.
At this one-hour webinar, we will show you how November Research Group can solve your common pharmacovigilance challenges with a simple and effective solution. The purpose of this webinar is to empower you with more control over your case intake process.
In this session with Brad Gallien, you will discover:
- Common challenges pharmacovigilance departments face in the safety email inbox process
- A systematic approach to better manage the intake and review of potentially reportable adverse events and complaints
- An easy and efficient way to communicate with reporters through correspondence management
- Industry best practices to prepare for intake process audits and inspections
Logo
Linguistic harmony in the Tower of Babel; how Amgen joins reference data from bench to bedside
The challenges associated with managing reference data create complexity and expense across all industries - in Life Sciences, Financial Services and Manufacturing, the problem is particularly acute.
Amgen – an American multinational biopharmaceutical company – tackles the reference data issue by creating a linked vocabulary that is leveraged across the Pharma pipeline to streamline processes and enable faster time to market.
The objective of this workshop is to show existing Oracle Database (Enterprise
Edition, Exadata, Autonomous Database, EXACS, DBCS) customers how to
attach your Database to Data safe and gain valuable understanding of
potential risks. Using user Assessment, understand rights and entitlement of
users and review activity auditing which provides powerful insight to database
interaction. The workshop will finish with a full sensitive data discovery and
then how to anonymize date with sensitive data masking.
The workshop is delivered in an interactive way with Presentations and Hands on
Labs to ensure complete understanding.
Covance Accelerator Methodology Delivers Validated Oracle Argus Cloud in Reco...Covance
A global pharmaceutical company wanted to integrate and implement individual safety databases for two of their subsidiaries on the Oracle Argus platform. Read how Covance implemented its Accelerator Methodology to deliver a robust, validated and secure solution in record time.
Similar to Safety and Pharmacovigilance System: Oracle Argus Safety Suite (20)
DevOps and Testing slides at DASA ConnectKari Kakkonen
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Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
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LF Energy Webinar: Electrical Grid Modelling and Simulation Through PowSyBl -...DanBrown980551
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Then welcome to this PowSyBl workshop, hosted by Rte, the French Transmission System Operator (TSO)!
During the webinar, you will discover the PowSyBl ecosystem as well as handle and study an electrical network through an interactive Python notebook.
PowSyBl is an open source project hosted by LF Energy, which offers a comprehensive set of features for electrical grid modelling and simulation. Among other advanced features, PowSyBl provides:
- A fully editable and extendable library for grid component modelling;
- Visualization tools to display your network;
- Grid simulation tools, such as power flows, security analyses (with or without remedial actions) and sensitivity analyses;
The framework is mostly written in Java, with a Python binding so that Python developers can access PowSyBl functionalities as well.
What you will learn during the webinar:
- For beginners: discover PowSyBl's functionalities through a quick general presentation and the notebook, without needing any expert coding skills;
- For advanced developers: master the skills to efficiently apply PowSyBl functionalities to your real-world scenarios.
State of ICS and IoT Cyber Threat Landscape Report 2024 previewPrayukth K V
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The latest edition of the OT/ICS and IoT security Threat Landscape Report 2024 also covers:
State of global ICS asset and network exposure
Sectoral targets and attacks as well as the cost of ransom
Global APT activity, AI usage, actor and tactic profiles, and implications
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Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
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https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
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Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
Safety and Pharmacovigilance System: Oracle Argus Safety Suite
1. ORACLE DATA SHEET
SUPPORTING DRUG SAFETY AND
REGULATORY COMPLIANCE WITH
ORACLE’S ARGUS SAFETY
Companies are increasingly shifting their focus to a more holistic view of
product safety beginning in clinical development and continuing through
post-market surveillance. Oracle’s Argus Safety is a comprehensive
platform designed specifically to address the life sciences industry’s
ORACLE’S ARGUS SAFETY IS complex pharmacovigilance requirements. Argus Safety’s advanced
A COMPREHENSIVE database helps ensure global regulatory compliance, enables sound safety
PHARMACOVIGILANCE decisions and integrates safety and risk management functions.
PLATFORM DESIGNED TO
ENABLE LIFE SCIENCES
COMPANIES TO FOCUS ON
Ensuring Global Regulatory Compliance
PRODUCT SAFETY AND
Life sciences organizations must ensure that they are compliant with global
COMPLIANCE.
regulations and guidance, including those of EMEA, FDA, ICH, and a
myriad of national authorities. Extensive license partnerships, as well as
WITH ARGUS SAFETY, outsourcing of some functions, complicate this scenario and the industry is
COMPANIES CAN: finding it increasingly challenging to manage its world-wide reporting
ENSURE GLOBAL obligations. Companies depend on Argus Safety to help manage their
REGULATORY regulatory compliance requirements in a timely and proactive manner.
COMPLIANCE
MAKE FASTER, SCIENCE- Managers and executives can obtain visibility into reporting metrics and
BASED SAFETY DECISIONS
compliance by leveraging Argus Safety’s advanced reportability
INTEGRATE SAFETY AND
functionalities, such as comprehensive dashboards and metrics. In addition,
RISK MANAGEMENT
Argus Safety’s flexible configuration can model virtually any business
LOWER THE COST OF
process, supporting case management and reporting compliance internally
PHARMACOVIGILANCE
as well as across license partner networks.
Argus Safety supports reporting compliance via a comprehensive and robust
reporting engine that allows users to configure specific rules to match
regulatory requirements. When combined with advanced automation
1
2. ORACLE DATA SHEET
features such as "Auto/Force Distribute" and "Auto-Submit", it enables full
compliance and can lower the cost of regulatory reporting.
Better Insight Into Safety Data for Faster Decision-Making
Argus Safety has been developed with input from leading life sciences
companies and industry thought leaders with a focus on efficient and
effective safety management.
The system is designed for fast safety data entry. Advanced functionality
such as dynamic workflows, worklist management, company-defined
reporting rules and extensive automation are incorporated to ensure
maximum case processing efficiency.
The system can be easily queried by end users without requiring SQL or the
support of IT departments. Thus, safety data is readily accessible for timely
review and reporting. Other modules can also be fully integrated with Argus
Safety, providing the ability to readily reconcile SAEs from clinical trials or
efficiently manage periodic reports.
Argus Safety’s focus on business process efficiency allows
2
3. ORACLE DATA SHEET
pharmacovigilance departments to focus on a drug’s clinical effectiveness at
lower overall cost. It provides complete insight into a drug’s safety profile
necessary to let executives make timely, science-based decisions on their
products and portfolios.
Integrating Safety and Risk Management
Pharmacovigilance departments are struggling with increasing case
volumes, disparate data sources and complex business partnerships,
challenging their ability to analyze and understand the safety data. The
industry is struggling to maintain process efficiencies while managing
product risk profiles in real time.
Argus Safety is a complete platform designed to address the industry’s end-
to-end safety and risk management needs. It includes a comprehensive tool
set for expedited and periodic reporting, capability for clinical trial SAE
reconciliation and partner AE management.
Argus Safety has native risk management capabilities to address regulatory
requirements and manage a product’s benefit:risk profile, including
reporting automation using advanced conditions, documentation storage,
collection of information for advanced visualization and for tracking
pregnancy registries. In addition, it can be seamlessly integrated with signal
detection and management systems to proactively mine safety data.
Companies can leverage the Argus Safety suite to ensure a proactive
approach to managing product safety, from clinical development to post-
marketing.
Industry Proven and Accepted
Argus Safety has been in use for over a decade at some of the industry’s
leading companies, including global pharmaceutical, biotech, CRO and
medical device manufacturers. It is continuously enhanced through a
defined and planned product roadmap.
3
4. ORACLE DATA SHEET
ORACLE ARGUS AFFILIATE
KEY FEATURES AND BENEFITS
Oracle Argus Affiliate works in conjunction with Oracle Argus
FEATURES
• Origination of cases via case
Safety to provide pharmaceutical and medical device companies with
entry screens an effective way to integrate business processes with contract
• Tracking of local data items
• Support for e-signatures
research organizations and other affiliates. With Oracle Argus
• Duplicate search capabilities Affiliate, you can improve worker productivity by reducing duplicate
• Local labeling decisions made
against local data sheet or
tasks and improve data safety by managing a single case database.
license
• Case views provided to
appropriate local affiliate
The Affiliate Challenge
• Ability for several affiliates to Bringing a new drug, device, or therapy to market has always been a complicated
simultaneously view and process involving multiple parties. However, in recent years, the number of
make local labeling calls
against the same locked case participants in clinical trials has increased. The contract—or clinical—research
• Views of core documents and organization (CRO) industry has developed as pharmaceutical research-and-
global protocols such as development efforts have become more complex. As the pharmaceutical industry
action items on a work list
• Central staging area for
concentrates resources on core skills, CROs and affiliate organizations help with
reviewing submitted affiliate many of the processes involved in bringing new compounds and devices to market.
cases All of these affiliate organizations are responsible for managing data, and all of them
• Electronic submission
use disparate systems. However, with Oracle Argus Affiliate, you can integrate all
capabilities
• Querying and reporting of affiliate sites into the global case workflow.
cases received and submitted
• Audit trails Product Overview
Oracle Argus Affiliate provides true integration of affiliate sites into your business
BENEFITS processes for case management and reporting. Affiliate sites are responsible for local
• Improve data safety with a
cases, but the central safety group at the contracting organization maintains overall
single case management
database visibility and control. Because Oracle Argus Affiliate eliminates manual processes,
• Realize immediate ROI by companies immediately see results in the form of increased worker productivity.
streamlining and integrating Finally, it integrates easily with Oracle Argus Safety, a comprehensive foundation
affiliate business processes
• Increase worker productivity
for case management and reporting.
by eliminating redundant data
Local Processing with Central Visibility
entry
• Reduce risk by allowing
Oracle Argus Affiliate allows case data entry at the source to minimize mistakes
central safety group to accept from dual entry. It provides a complete case review, acceptance of the case into the
or reject affiliate cases
central database, and determination of whether a case is reportable—all at the local
level. Affiliate sites receive only cases that are specific to the local site, and users
manage and track only the cases specific to their workflow. The central safety
department retains full visibility into all affiliate sites and decisions through a single
case database.
1
5. ORACLE DATA SHEET
RELATED PRODUCTS Productivity Improvement
Oracle Argus Affiliate delivers immediate return on investment, by eliminating
The Oracle Argus product
family delivers a redundant data entry, streamlining paper-based processes, and eliminating the need
comprehensive, Web-based for fax or e-mail communications. This Web-based module utilizes Oracle Argus
software solution to support
Safety’s central database and does not require additional resources to maintain the
the future vision of integrated
safety and risk management system.
for the biopharmaceutical
industry. With it, health Full Integration with Oracle Argus Safety
sciences companies can Oracle Argus Affiliate works in tandem with Oracle Argus Safety to seamlessly
manage the case lifecycle,
from entry to reporting and integrate local affiliate sites into the worldwide safety workflow via a single case
analysis. It is highly database. The central safety department retains control of the environment and the
configurable to meet the
ability to provide restricted access. It therefore also provides a convenient way to
requirements of small to very
large customers without integrate CROs into the safety reporting process.
customization, and it scales to
perform under the most-
stringent workloads in global
deployments. Oracle’s safety
reporting and monitoring
solutions support holistic,
integrated, and proactive risk
management strategies and
provide better analytics and
insight into safety data.
RELATED PRODUCTS
The following products
constitute the Oracle Argus
product family:
• Oracle Argus Safety
• Oracle Argus Safety Japan
• Oracle Argus Insight
• Oracle Argus Perceptive
• Oracle Argus Affiliate
• Oracle Argus Dossier
• Oracle Argus Interchange
• Oracle Argus Reconciliation
• Oracle Argus Unblinding
2
6. ORACLE DATA SHEET
ORACLE ARGUS INTERCHANGE
KEY FEATURES AND BENEFITS
Oracle Argus Interchange is the electronic submission and exchange
FEATURES
• Graphical display that
component of the Oracle Argus product family. It allows
presents transmission status pharmaceutical companies to share important drug safety
• Compliance with ICH:E2B and
CDISC:ODM standards information with partners in accordance with regulatory guidelines.
• Integration with Oracle Argus
Safety
• Immediate case triage upon The Data Exchange Challenge
receipt of electronic data In pursuit of drug safety, pharmaceutical companies share information and data with
licensing partners, clinical research organizations, laboratories, and hospitals. In
BENEFITS addition, case safety reports are submitted to regulatory agencies including the
• Delivers rapid ROI
European Medicines Agency (EMEA), the U.S. Federal Drug Administration
• Eliminates data entry
(FDA), and Japan’s Pharmaceutical and Medical Devices Agency (PMDA). So
redundancy and errors
associated with manual much data is shared that the International Conference on Harmonisation has
data input published guidelines (ICH:E2B) for electronic data exchange that guard patient
• Allows timely information
privacy and ensure that the necessary information is included in the transmission.
sharing with partners and
agencies worldwide
Product Overview
Oracle Argus Interchange allows for secure, electronic exchange of drug safety
information. Transmission of required data elements from case safety reports is done
in accordance with ICH:E2B guidelines.
Electronic Exchange with Partners and Regulators
Oracle Argus Interchange enables pharmaceutical companies to exchange vital drug
safety information with regulators and partners worldwide. Cases are reported
instantly and accurately using standardized, global reporting and transmission
processes. A color-coded graphical display delivers real-time insight into
transmission status. Pharmaceutical companies can immediately triage cases upon
electronic intake of data using a selective intake process. Importantly, Oracle Argus
Interchange is seamlessly integrated with Oracle Argus Safety to facilitate the
import, export, and transmission of case safety reports.
Link for Preclinical and Post-Marketing Safety Information
Oracle Argus Interchange provides the critical link for connecting the preclinical
and post-marketing domains. This crucial component allows communication
between pharmaceutical companies’ e-clinical and safety systems and delivers
immediate return on investment. Oracle Argus Interchange will allow any standards-
based systems—from those based on the ICH:E2B electronic reporting format to
those using the Clinical Data Interchange Standards Consortium’s operational data
modeling (CDISC:ODM)—to instantly exchange adverse events data. It thereby
eliminates costly data entry redundancy and any possibility of introducing errors.
1
7. ORACLE DATA SHEET
RELATED PRODUCTS Fully Integrated Safety System
Oracle Argus Interchange provides the unique ability to configure the business rules
The Oracle Argus product
family delivers a for transmission and import profiles. The graphical display tracks individual case
comprehensive, Web-based summary reports (ICSRs) to meet service level agreements for regulators and
software solution to support
trading partners. In addition, selective intake for the acceptance of initial and follow-
the future vision of integrated
safety and risk management up ICSRs increases business and IT productivity. Seamless integration with Oracle
for the biopharmaceutical
Argus Safety allows users to create and update cases eliminating duplicate data entry
industry. With it, health
sciences companies can and reducing case processing times.
manage the case lifecycle,
from entry to reporting and
analysis. It is highly
configurable to meet the
requirements of small to very
large customers without
customization, and it scales to
perform under the most-
stringent workloads in global
deployments. Oracle’s safety
reporting and monitoring
solutions support holistic,
integrated, and proactive risk
management strategies and
provide better analytics and
insight into safety data.
RELATED PRODUCTS
The following products
constitute the Oracle Argus
product family:
• Oracle Argus Safety
• Oracle Argus Safety Japan
• Oracle Argus Insight
• Oracle Argus Perceptive
• Oracle Argus Affiliate
• Oracle Argus Dossier
• Oracle Argus Interchange
• Oracle Argus Reconciliation
• Oracle Argus Unblinding
2
8. ORACLE DATA SHEET
MANAGING CLINICAL
CLINICAL-TO-SAFETY
RECONCILIATION WITH ORACLE’S
ARGUS RECONCILIATION
Companies are increasingly shifting their focus to a more holistic view of
product safety from clinical development continuing through p post-market
surveillance. The Oracle Argus Safety Suite is an integrated platform
desi
designed specifically to address the life sciences industry’s complex
ORACLE’S ARGUS pharmacovigilance requirements. Oracle’s Argus Reconciliation, a
cle’s
RECONCILIATION IS PART OF component of the Argus Safety Suite, helps life sciences companies
THE ARGUS SAFETY SUITE. simplify the cumbersome clinical-to-safety reconciliation process.
safety
IT SUPPORTS THE CLINICAL
TO SAFETY RECONCILIATION Improved Operational Efficiency
PROCESS TO: Inconsistent data between disparate clinic and safety systems can lead to
clinical
false conclusions about the safety profile of a drug Reconciling this
drug.
• Deliver Significant Operational
Efficiency Gains
pharmacovigilance information across departments is a significant
• Lower The Cost Of Clinical-
challenge. Life sciences organizations spend significant time and resources
To-Safety Reconciliation
to overcome this data silo challenge by performing manual quality checks.
silo
• Help Integrate Safety And
Risk Management Activities Argus Reconciliation reduces the burden of this process by reconciling drug
safety data from clinical data management systems with the Oracle Argus
Safety database. It significantly improves productivity by eliminating
productivity
double data entry and reducing the possibility of introducing errors It’s
ssibility errors.
intuitive and user friendly graphical interface helps identify discrepancies
user-friendly
quickly and easily, helping companies shorten the reconciliation process.
Interac
Interactive Reconciliation Report
After Argus Reconciliation automatically extracts data from clinical data
management systems and reconciles it with the Argus Safety database, it
generates an advanced, interactive reconciliation report. This report allows
for easy visual determination of case-by-case data discrepancies. Argus
case
Reconciliation can also be used to generate full reconciliation reports. For
maximum flexibility, comparison and update routines are implemented as
database
database-stored procedures.
1
9. ORACLE DATA SHEET
ORACLE’S ARGUS Lower cost of reconciliation and pharmacovigilance
SAFETY TECHNICAL The disparate nature of safety and clinical systems forces companies to
SPECIFICATIONS
divert limited resources to redundant tasks such as double-data entry and
• Client:
quality checks instead of focusing on strategic pharmacovigilance activities.
- Windows XP SP1,2 or 3
(IE 7 or 8), and Vista SP1
This can significantly affect the cost of pharmacovigilance operations.
(IE7 or 8) client)
• Middle Tier: Argus Reconciliation eliminates the need for data entry and vastly
- Windows 2003 Server simplifies the process of reconciliation. Because it significantly reduces the
• Database: number of hours that full-time employees spend on data reconciliation,
- Oracle 11g
Argus Reconciliation delivers an immediate return on investment (ROI) to
- HP-UX Itanium 11.31
life sciences companies. In addition, pharmacovigilance managers are thus
- Sun Solaris (SPARC) 9, 10
able to focus their resources on valuable drug safety analysis rather than
resource-intensive reconciliation.
- Windows 2003 Server
Integrated Safety and Risk Management
Argus Reconciliation is part of the Argus Safety Suite, an integrated
platform that supports end-to-end safety and risk management activities.
The Argus Safety Suite offers native risk management capabilities to
address regulatory requirements and manage a product’s benefit:risk profile
(including reporting automation using advanced conditions, documentation
storage, collection of information for advanced visualization and for
tracking pregnancy registries.) It can also be seamlessly integrated with
signal detection and risk management systems for proactive data mining.
Companies can leverage the Argus Safety Suite, including Argus
Reconciliation, to increase linkages across clinical safety and post-
marketing surveillance, enabling companies to focus on managing a
product’s safety profile.
2
10. ORACLE DATA SHEET
ORACLE ARGUS DOSSIER
KEY FEATURES
Oracle Argus Dossier is a collaborative, Web-based solution that
REPORTING FEATURES
• Global, standardized, and
manages the entire lifecycle of periodic dossiers, from planning,
repeatable templates for collaborating, producing, and submitting to task tracking and
product-level reports
• XML-based scripting management. Designed in collaboration with leading
language for writing templates
pharmaceutical companies, it significantly streamlines and simplifies
• A worldwide marketing
authorization table template the document writing process for periodic report production. It
• Full reporting schedule
manages and plans the reporting schedule ahead of submission
calendar with complete
delineation of DLP for initial deadlines. Oracle Argus Dossier puts data into perspective and
and follow-up reports
• One-time configuration to
creates a holistic picture of a drug with respect to its exposure over a
automatically schedule period of time. In conjunction with Oracle Argus Safety—a
periodic reports throughout a
product’s lifecycle comprehensive foundation for case management and reporting—
• Generation and inclusion of
MedWatch, CIOMS II, VAERS
Oracle Argus Dossier is a critical component of pharmaceutical
expedited reports, line listings, companies’ pharmacovigilance and risk management strategies.
and summary and other
tabulations
The Periodic Dossier and Report Challenge
MANAGEMENT FEATURES
To ensure the safety and marketability of pharmaceutical products, periodic dossiers
• Collaboration platform for
and reports must be filed with regulatory agencies. Pharmaceutical companies
report authoring and
submission review the cumulative safety information obtained from a wide range of sources—
• Management reports for including spontaneous reports and clinical study results—on a periodic basis and
resource estimation, planning,
submit the findings to regulators worldwide. The exact type of report submitted
and status tracking
• Audit records for all document
varies by country and with the approval status of the medicine. Preapproval reports
management activities may provide cumulative information or contain aggregate information specific to the
• Distribution of reporting tasks reporting period. Postapproval cumulative reports of safety update and evaluate the
to individual team members
based on report sections
worldwide safety experience with a medicine at defined time points after approval.
• Workflow tools for controlling Generally speaking, these reports provide succinct summary information, together
and managing report with an evaluation of the risk/benefit profile of approved medicines in light of new
authoring and submission
cycles
or changing information. This evaluation is designed to help ascertain whether
• Customizable e-mail further investigations need to be carried out and whether changes should be made to
notification features the approval and/or to the medicine’s labeling. Creating such reports is a data- and
• Ability to edit generated
regulation-intensive task.
templates with Microsoft Word
• Generation of submission-
ready dossiers in PDF format Product Overview
with bookmarks Oracle Argus Dossier simplifies creation of periodic reports. It not only provides
• Complete interface with
global and product-level templates but is also able to generate new periodic reports
Documentum for intermediate
draft and final reports based on those templates and provides you with a flexible XML-based scripting
language for writing new templates. Because it maintains a full reporting calendar,
you know when to file the reports relative to the data lock point (DLP) date. Besides
offering features that facilitate report creation, Oracle Argus Dossier helps manage
1
11. ORACLE DATA SHEET
RELATED PRODUCTS the entire process by providing a platform for tracking report authoring and
submission, generating management reports, and providing audit records.
The Oracle Argus product
family delivers a More Rapidly Produce Periodic Dossiers
comprehensive, Web-based
software solution to support Oracle Argus Dossier’s role-based workflow eliminates resource-intensive, manual
the future vision of integrated work and saves substantial hours of employee work. It structures the publishing
safety and risk management
process so regulatory obligations can be met in a timely manner. Drug safety
for the biopharmaceutical
industry. With it, health departments can utilize Oracle Argus Dossier’s advanced calendar management
sciences companies can capability to manage the entire reporting lifecycle, from planning, collaborating,
manage the case lifecycle,
from entry to reporting and producing, and submission to task tracking and management.
analysis. It is highly
configurable to meet the
Focus on Important Information
requirements of small to very Oracle Argus Dossier provides visibility into data, ensuring that drug safety
large customers without departments are able to collect the right information. It enables companies to
customization, and it scales to
perform under the most- maximize the time they spend on safety analysis rather than time-consuming,
stringent workloads in global remedial tasks. Data is presented in the correct context—providing a holistic picture
deployments. Oracle’s safety
of pharmaceutical products with respect to their exposure over a period of time.
reporting and monitoring
solutions support holistic,
Fully Integrated Safety System
integrated, and proactive risk
management strategies and Oracle Argus Dossier seamlessly integrates with other products in the Oracle Argus
provide better analytics and product family, so pharmaceutical companies have the option of adding further
insight into safety data.
functionalities. When integrated with Oracle Argus Safety, Oracle Argus Dossier
becomes a key part of a comprehensive risk management system.
RELATED PRODUCTS
The following products
constitute the Oracle Argus
product family:
• Oracle Argus Safety
• Oracle Argus Safety Japan
• Oracle Argus Insight
• Oracle Argus Perceptive
• Oracle Argus Affiliate
• Oracle Argus Dossier
• Oracle Argus Interchange
• Oracle Argus Reconciliation
• Oracle Argus Unblinding
2
12. ORACLE DATA SHEET
ORACLE ARGUS INSIGHT
KEY FEATURES AND BENEFITS
Oracle Argus Insight is an analysis tool for safety data adopted by
FEATURES
Multidimensional reports
global pharmacovigilance specialists. It provides comprehensive
Analysis of safety data analysis of pharmaceutical safety data for making key business
Denormalized data for
decisions quickly and confidently. With a comprehensive
efficient querying
More than 150 standard knowledgebase, an extensive report library, simplified querying and
reports
Ad hoc querying and reporting
reporting, and easy data access, Oracle Argus Insight is a
with report writer comprehensive data analysis solution that delivers analytics and
Drill-down analysis through
text or graphs with cubes
insight into safety data.
Dashboard indicators to
provide timely, complete The Data Analysis Challenge
information to all user levels
Automated scheduling and e-
Bringing new drugs and medical devices to market has always been a complicated
mailing process involving corporations, government, laboratories, doctors, and patients.
Derivation rules for creating However, in recent years, the number and complexity of clinical trials required to
computed values in the data
prove the efficacy of therapies are increasing. In addition, more parties—sponsors,
mart
contract (or clinical) research organizations (CROs), trial sites, regulatory agencies,
BENEFITS and medical institutions—are managing research and generating data. Finally, new
Provides visibility into and observational safety datasources are emerging, including insurance claims,
strategic data across the diagnostic tests, and prescriptions. Increasing amounts of data from multiple sources
enterprise
Provides users and managers
have made the collection and analysis of safety data more complex. Health science
with the ability to quickly and companies require a tool that can turn data into insight so managers and executives
easily access required can make better decisions based on timely, relevant information.
information
Eliminates the need to involve Product Overview
IT in running reports and
queries
Oracle Argus Insight offers multidimensional analysis of pharmaceutical safety data
Uncovers key, statistically to create reports that enable employees to make key business decisions quickly and
significant data for managing confidently. Whether conducting analyses on workflow or product data, managers
the risk/benefit profiles of
drugs
realize improved performance. The ability to rapidly create ad hoc queries without
Supports key decision-making restrictive parameters allows user-defined analysis and visualization of safety data.
by compiling and analyzing In addition, Oracle Argus Insight’s querying features eliminate the need for IT to run
data
queries in SQL, so business users are empowered to get the information they need.
Data can be accessed securely over the Web for instant, global decision-making.
Comprehensive Knowledgebase
Oracle Argus Insight’s flexible extract, transfer, and load (ETL) engine populates a
data warehouse with drug safety data and information such as sales, clinical trials, or
product dictionary data to create a comprehensive knowledgebase. With denormal-
ization, Oracle Argus Insight can extract key information from a company's data
mart to deliver efficient querying, drill-down analysis, and report generation—all
without impeding the daily use of mission-critical drug safety databases.
1
13. ORACLE DATA SHEET
RELATED PRODUCTS Extensive Report Library
Argus Insight delivers more than 150 standard reports that provide knowledge on
The Oracle Argus product
family delivers a regulatory compliance, products and licenses, pharmacovigilance, productivity, case
comprehensive, Web-based volume, and case processing. The reports can highlight medical analysis and track
software solution to support
key performance indicators (KPIs). They can be readily shared in Microsoft Excel
the future vision of integrated
safety and risk management for further drill-down or in Adobe Acrobat for external distribution. Finally, users
for the biopharmaceutical
can define report outputs to meet their own regulatory reporting and/or corporate
industry. With it, health
sciences companies can reporting requirements. As a result, the standard reports can be configured to meet
manage the case lifecycle, the needs of individual companies.
from entry to reporting and
analysis. It is highly Querying and Reporting for Business Users
configurable to meet the
With Oracle Argus Insight, medical reviewers can create queries and custom reports
requirements of small to very
large customers without from millions of cases in just minutes. Companies can clearly analyze and visualize
customization, and it scales to safety data and event-level information to support risk management and signal
perform under the most-
stringent workloads in global
detection. Users of all skill levels can conduct simple or advanced queries, eliminat-
deployments. Oracle’s safety ing the need for IT to run complex SQL queries. Built-in query methods include
reporting and monitoring
solutions support holistic, Query by example. Simple queries can be constructed from an easy-to-use
integrated, and proactive risk
interface that gives business users easy access to relevant data.
management strategies and
provide better analytics and Filters. Filters enable several parameters to be incorporated into a single,
insight into safety data.
complex query while maintaining usability.
RELATED PRODUCTS Advanced conditions. The most advanced query tool allows granular queries
The following products by enabling users to set conditions on every aspect of the safety process.
constitute the Oracle Argus
product family: Easy Access to Data
Oracle Argus Safety
Argus Insight enables medical reviewers to drill down through all data levels, using
Oracle Argus Safety Japan
common attributes to obtain the focus they desire. Numerous preformed, standard
Oracle Argus Insight
reports for pharmacovigilance minimize startup time. First-time users can quickly
Oracle Argus Perceptive
Oracle Argus Affiliate access data and then efficiently produce and analyze reports that provide immediate
Oracle Argus Dossier business impact by improving decision-making. In addition, easy access to data
Oracle Argus Interchange supports risk management processes and speeds response to regulatory inquiries.
Oracle Argus Reconciliation
Oracle Argus Unblinding
Fully Integrated Safety System
Oracle Argus Insight seamlessly integrates with the Oracle Argus product family.
Oracle Argus Safety and Oracle Argus Perceptive can both be integrated with Oracle
Argus Insight to deliver a comprehensive risk management tool.
2
14. ORA
ACLE DATA SHEE
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• RISK MITIGATION
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In
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Pr
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Chhi-Square (χ2)
95 Confidence Intervals (95% C.I.)
5% e %
Complete SMQ support
In
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Case Scoring
In
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n e
1
15. ORACLE DATA SHEET
Risk Analysis
Beyond signal detection, Argus Perceptive also provides an integrated
platform for risk analysis, enabling real-time analysis as soon as a risk is
detected, as well as providing the ability to stratify cases to further
understand the public health impact. To ensure regulatory compliance, an
integrated environment also supports the tracking of regulatory inquiries for
on-going risk management obligations from RMPs and REMS. Advanced
features include:
Advanced risk analysis features
Summary Report a breakdown of the case series, automatically
calculated and included with each triggered alert
Analysis Report multifaceted report with color-assisted
visualization of multiple algorithmic thresholds
Content Matrix intuitively aids the signal analyst in finding
neighboring cases to add to the case series
Increased Color-differentiated report that is supported by
Frequency Report patient exposure data as defined by the FDA
increased frequency algorithm
For additional analysis, Argus Perceptive seamlessly integrates with
Oracle’s Argus Insight, the business intelligence and analytics tool for
pharmacovigilance. Argus Insight provides the risk assessor with powerful
querying capabilities, a predefined library of multidimensional reports,
user-friendly ad hoc report creation, and audited case series updating and
freezing functionality. With a single click, case series can be passed from
Argus Perceptive to Argus Insight and vice versa, providing the ultimate
analytic flexibility.
Risk Mitigation
Confirmed risks must be addressed within company SOPs to support REMS
and RMP requirements. Argus Perceptive offers a structured approach for
risk mitigation, ensuring adherence to the company pre-defined SOP for
triage, assessment, mitigation and follow-up. This includes features such as
flexible and fully configurable workflows, including group worklists,
workflow rules, due dates and action items. Actions resulting from a
confirmed signal are tracked and documented in a collaborative
environment, while risk assessors may also schedule reports and queries to
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16. ORACLE DATA SHEET
ORACLE’S ARGUS ensure timely assessments. Argus Perceptive thereby enables a continuous
PERCEPTIVE TECHNICAL
SPECIFICATIONS
process of assessment and mitigation based on a product’s identified risk.
• Web server: Windows
Argus Perceptive can store the company's global Signal Workup Document
2003 SP2 Standard &
Enterprise
template so that the latest version is instantly and centrally available to
• Database server:
signal analysts. Check-out and check-in as well as version history is
Windows 2003 SP2 supported by the application. The final Signal Workup Document is stored
Standard & Enterprise, together with the triggered alert so that all relevant information is in one
Red Hat Linux 5.0 place.
• Oracle server: Oracle
Standard & Enterprise Through the process of archiving both confirmed signals and alerts
10.2.0.4, 11.1.0.7 evaluated as non-risks for the time being, risk assessors build an invaluable
• Client: XP Pro SP3 / Vista knowledgebase in Argus Perceptive over time. The application can be
SP1 all versions configured to continue monitoring for new cases that can awaken latent,
archived alerts in the knowledgebase and give analysts the opportunity to
reevaluate the situation. Additionally a watchlist with reminder
functionality keeps important alerts on the radar screen.
Management gains visibility into risk metrics for each product via executive
dashboards, providing the ability to make safety-based portfolio decisions.
Importantly, Argus Perceptive also enables companies to rapidly respond to
regulatory inquiries, helping to ease the burden of compliance.
Argus Perceptive, in conjunction with Argus Insight and Oracle’s Argus
Dossier, allows companies to manage the benefit:risk profile across their
entire product portfolio. Oracle’s risk management solutions thus help life
science companies move beyond mere regulatory compliance to focus on
holistic product stewardship.
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