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.
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
Introduction to Argus Event Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
GVP stands for Good Pharmacovigilance Practices, which are a set of guidelines and regulatory requirements that provide a framework for the conduct of pharmacovigilance activities. The GVP modules outline specific areas of pharmacovigilance and provide detailed guidance on various aspects. Here are the main GVP modules
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
Introduction to Argus Event Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
GVP stands for Good Pharmacovigilance Practices, which are a set of guidelines and regulatory requirements that provide a framework for the conduct of pharmacovigilance activities. The GVP modules outline specific areas of pharmacovigilance and provide detailed guidance on various aspects. Here are the main GVP modules
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
Introduction to Argus Product Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Argus Analysis Tab Screen in Pharmacovigilance or Drug Safety of 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.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality systemMohamed Raouf
This Module contains guidance for the establishment and maintenance of quality assured Pharmacovigilance systems for marketing authorization holders (MAHs) and national medicine authorities (NMAs).
Reference:- Guideline on good pharmacovigilance practices (GVP) version no.3
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
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.
ARGUS Query Process Overview_Katalyst HLSKatalyst HLS
Introduction to ARGUS Query Process Overview 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.”
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
Collection, Processing and Reporting of ICSRClinosolIndia
The collection, processing, and reporting of Individual Case Safety Reports (ICSRs) in pharmacovigilance involve several key steps and activities. Here's an overview of the process
Enriching the Value of Clinical Data with Oracle Data Management WorkbenchPerficient, Inc.
To effectively conduct clinical research and development you need to collect, manage, and visualize clinical and healthcare data – including mHealth data – using a centralized and secure data repository that can be considered the single source of truth.
Oracle Data Management Workbench (DMW) is a proven solution that is used by a number of global pharmaceutical and medical device organizations to aggregate and manage clinical data in support of their R&D initiatives.
In this SlideShare, we demonstrate how Oracle DMW can quickly enrich and expand the value of clinical data, as well as support enhanced analytics and decision-making.
Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
Introduction to Argus Product Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Argus Analysis Tab Screen in Pharmacovigilance or Drug Safety of 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.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality systemMohamed Raouf
This Module contains guidance for the establishment and maintenance of quality assured Pharmacovigilance systems for marketing authorization holders (MAHs) and national medicine authorities (NMAs).
Reference:- Guideline on good pharmacovigilance practices (GVP) version no.3
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
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.
ARGUS Query Process Overview_Katalyst HLSKatalyst HLS
Introduction to ARGUS Query Process Overview 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.”
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
Collection, Processing and Reporting of ICSRClinosolIndia
The collection, processing, and reporting of Individual Case Safety Reports (ICSRs) in pharmacovigilance involve several key steps and activities. Here's an overview of the process
Enriching the Value of Clinical Data with Oracle Data Management WorkbenchPerficient, Inc.
To effectively conduct clinical research and development you need to collect, manage, and visualize clinical and healthcare data – including mHealth data – using a centralized and secure data repository that can be considered the single source of truth.
Oracle Data Management Workbench (DMW) is a proven solution that is used by a number of global pharmaceutical and medical device organizations to aggregate and manage clinical data in support of their R&D initiatives.
In this SlideShare, we demonstrate how Oracle DMW can quickly enrich and expand the value of clinical data, as well as support enhanced analytics and decision-making.
Improve Your Business Processes with Oracle Order Management CloudPerficient, Inc.
According to IDC, by 2019, 50% of manufacturing supply chains will have benefited from digital transformation, with the remainder held back by outdated business models or functional structures.
Improving business processes is a top supply chain priority, especially in a digitally enabled world. If you’re looking to modernize your supply chain by making a move to the cloud, this is an opportunity to see the look and feel of Oracle Supply Chain Management Cloud with a drill-down into Drop Ship.
We covered:
-Key benefits and features of Oracle Order Management Cloud
-Drill-down into drop shipment functionality
-Key components for a successful implementation
-Client success story
Population Health Colloquium 2015: Mini Summit IV: Who is Your Champion of Cl...Perficient, Inc.
Oracle and Perficient presented at the 2015 Population Health Colloquium.
In this presentation thought leaders explored four types of change (Evolutionary, Disruptive, Imposed and Deliberate) and how all are needed in Healthcare. The discussion covered challenges and goals of integrating analytics (including retrospective data) into the clinician workflow within the EMR and how the Chief Informatics Officer is the best organizational role to champion analytics.
Driving Digital Transformation with Oracle Procurement CloudPerficient, Inc.
If you are looking for a robust Procure-to-Pay (P2P) solution with automated workflows and that’s fully integrated with manufacturing, order management, and financials, then look no further than Oracle Procurement Cloud.
Oracle Procurement Cloud seamlessly integrates with suppliers, invoices, customers, manufacturing and everything supply chain.
Modern procurement systems streamline the procurement process, minimizing manual transactions and delivering significant cost savings and improved processes. Whether you are in order fulfillment or operations, your colleagues are driving digital transformation by including cloud in their supply chain strategy.
We took a deeper look at Oracle Procurement Cloud and:
-Detailed the key benefits and features
-Explored drill-down into drop shipment functionality, payables, and financials
-Outlined the key components for a successful implementation
-Presented a client success story
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
Fulfilling Real-Time Analytics on Oracle BI Applications PlatformPerficient, Inc.
Are you interested in learning how to leverage your investment in Oracle BI Applications and perform real-time analytics? Do you need to see updates as they occur in real-time with no latency? This session covers how Oracle Business Intelligence Applications can be easily customized to fulfill real-time reporting requirements by leveraging the Oracle BI Apps architecture. It provides an overview of Oracle BI Applications, walks through the design steps to fulfill real-time capabilities, and addresses architectural questions around mitigating the impact on business applications.
A Customer's Take on Moving from Discoverer to Oracle Business AnalyticsPerficient, Inc.
If you’re among the many Oracle E-Business Suite customers still using Discoverer for your reporting and analytics needs, change is inevitable. But it doesn’t have to be disruptive to your business. For Group Voyagers, a group of leading escorted tour, river cruise and independent travel package companies, moving off Discoverer took just nine weeks!
Gary Aragon, accounting manager at Group Voyagers, joined us to discuss the company’s long-term reporting strategy and how it was able to successfully migrate to Oracle BI Enterprise Edition (OBIEE). Discussion included:
-Replacement Options - OBIEE and Oracle Analytics Cloud
-Best practices, methodologies, and deployment risks
-User adoption
-Benefits realized with OBIEE
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.
Catalogic DPX: Dashboard Reporting with Microsoft Power BICatalogic Software
Dashboard Reporting for Catalogic DPX is an easy to use, fully customizable reporting tool that lets you quickly see the overall status of your DPX environment, while also offering drill-down into details. Microsoft Power BI provides the end-user interface to DPX data collected by a custom Catalogic utility. The result is a detailed and insightful view of your DPX enterprise that provides at-a-glance information about job status, job performance, media utilization, helps identify problem areas and more.
D365 Finance & Operations - Data & Analytics (see newer release of this docum...Gina Pabalan
This very comprehensive white paper provides a detailed and clear overview of Microsoft's D365 Finance & Operations solutions to support Data & Analytics.
There is a newer version of this available - search SlideShare for the new version of this deck.
The world is quite a different place than it was six months ago, and with the 2020 holiday season fast approaching, the pressure is on to meet revenue goals in what’s been an uncertain year.
In August, we surveyed 154 marketing executives to find out what they think is likely to happen this holiday season and how they are preparing for it. The results are fascinating, and we’ve distilled them into clear actions you can take right now to adapt and prepare for a very different 2020 holiday season.
In this webinar, Eric Enge (Principal, Digital Marketing at Perficient) and Jim Hertzfeld (Chief Strategist, Digital at Perficient) discussed:
How marketers have already adapted and where they see the most opportunity moving forward
What will be different this holiday season and how to adjust your strategy accordingly
Ways to identify and meet changing customer expectations, wants, and needs
How to determine if your priorities or investments should change
What actions you can take right now to be successful
Transforming Pharmacovigilance Workflows with AI & Automation Perficient, Inc.
Medical information call centers have an opportunity to transform the way they capture, code, and analyze adverse events (AEs) and product quality complaints (PQCs) with artificial intelligence (AI) and automation.
The use of such innovative technology improves data quality and consistency, compliance, and operational efficiency. It helps reduce the frequency of your pharmacovigilance (PV) operations resources going home, saying, “I have more to do at the end of the day than I did when I started."
Our one-hour, on-demand webinar shows you how you can use AI and automation to turbo-charge your end-to-end PV system. Use cases and demonstrations will include:
Analyzing safety data
Auto-coding verbatim terms to official medical dictionary terms
Auto-creating an AE case in your database
Converting speech to text
The Secret to Acquiring and Retaining Customers in Financial ServicesPerficient, Inc.
Data, when leveraged effectively, can help you segment and target customers, analyze spending habits, and can create a personalized experience that builds value and customer loyalty.
Without a 360-degree view of your customers, you can’t properly target them with real-time personalized offers, advice, and other services. In addition, lack of customer intelligence creates lost opportunities for banks and insurers to cross-sell and upsell new products and services.
Our one-hour webinar covered how customer intelligence platforms can help you engage, acquire, and retain customers.
Oracle Strategic Modeling Live: Defined. Discussed. Demonstrated.Perficient, Inc.
The only thing certain about forecasting in a volatile economy is that the future is unpredictable. Historically, organizations have effectively utilized statistical techniques for short-term business planning, but leveraging actuals no longer allows us to predict the future. The ability to be prepared, responsive, and agile under these conditions is becoming a crucial success factor. Oracle Strategic Modeling can help you better navigate change to cope with uncertainty.
If your CFO’s questions regarding earnings, liquidity, and cash flow are unceasing and far-reaching, watch our on-demand webinar for a deep dive into strategic modeling. We modeled real-world scenarios to show how you can:
Quickly and easily develop a hierarchical model of your business
Leverage multiple pre-built functions to forecast key performance drivers
Provide transparency on forecasted financials via audit trail
Utilize goal seek to set financial targets and estimate the financials drivers necessary to achieve it
Perform sophisticated “what-if” analysis via simulations to improve the accuracy of your forecast
Use built-in dashboard functionality to deliver powerful reporting capabilities
While many stay-at-home orders have been lifted, consumers’ new digital buying behaviors and habits are here to stay. Watch our panel discussion on the accelerated need for commerce and learn how commerce and content can transform our digital economy.
Topics include:
-What is the “experience economy” and how do you leverage it? -If you move beyond product and price, what’s next?
-How business models have shifted and what you can do to break down silos and leverage new processes to capture the digital dollar.
-How organizations have built agile teams to address the ever-changing needs of customers, including responsive approaches that address the omnichannel consumer.
-Technologies that are best suited to enable your business and customers – and how headless commerce has changed the game.
-How the future of commerce is changing, and what you should do now to prepare.
Our panel features Jordan Jewell, IDC Research analyst known for his insight into the commerce industry. Joining him from Perficient is general manager Brian Beckham, who brings deep expertise in content management and empowering organizations in their digital transformations. Rounding out the panel is Episerver’s Joey Moore, who has spent the last decade helping organizations across the globe advance their digital maturity.
Centene's Financial Transformation Journey: A OneStream Success StoryPerficient, Inc.
Centene, a large multi-line managed care organization, was looking to modernize and streamline its corporate performance management (CPM) applications.
Centene had to move data between platforms multiple times during the close process so that close data could be fully consolidated and made available for reporting. This process had numerous challenges and inefficiencies that Centene wished to improve upon so that they could provide a more streamlined and more transparent process to the functional teams that leverage consolidated financials in their systems for reporting and analysis.
Centene chose OneStream XF for global and US consolidations, currency conversion, eliminations, and ownership percentage.
Michael Vannoni, director, financial systems solutions discussed the migration to OneStream XF including:
-Factors leading to the selection of OneStream XF
-Details of the solution design
-Benefits realized with global consolidation implementation
-Future planned enhancements
WHODrug Koda, developed by Uppsala Monitoring Centre (UMC), is an automated coding service, which uses artificial intelligence (AI) to automate the coding of drug names and ATC selections, improving consistency and operational efficiency. It can also be used to accelerate dictionary upgrades, including the transition from WHODrug B2 format to B3.
Through API (Application Programming Interface) web services, the coding engine can be integrated with custom or off-the-shelf drug safety, medical coding, or data management systems.
In this webinar, Perficient and UMC discussed WHODrug Koda and how you can integrate it into your medical coding activities.
Preparing for Your Oracle, Medidata, and Veeva CTMS Migration ProjectPerficient, Inc.
There are multiple reasons why companies migrate to a new clinical trial management system (CTMS). Still, the two most common are mergers and acquisitions (i.e., CTMS consolidation) and the desire to switch CTMS vendors. Regardless of the reason, many of the best practices, processes, and tools are the same.
In this webinar, we looked at the migration approaches taken across several case studies. You’ll come away with an understanding of:
Pros and cons of each CTMS migration method
Types of migration tools, including APIs, ETL tools, and adapters
Approximate timelines and costs associated with each migration method
The topics discussed in this webinar can be applied to any CTMS migration project, whether you’re moving to or from Oracle’s Siebel CTMS, Medidata’s Rave CTMS, and Veeva’s Vault CTMS.
Accelerating Partner Management: How Manufacturers Can Navigate Covid-19Perficient, Inc.
The pandemic has ushered in a new normal for manufacturers, and the impact of digital communication is more important than ever.
View our on-demand webinar with Tony Kratovil, Regional Vice President of Manufacturing at Salesforce, and Eric Dukart, National Sales Executive at Perficient. They covered why the right digital strategies are critical for manufacturers in the wake of COVID-19.
Our webinar covered:
Current challenges with forecasting, collaboration, and disruptions to distribution networks.
Insights for stabilizing operations, accelerating partner management, and developing a digital strategy that differentiates your business.
Candid Q&A with real-world examples.
New Work.com resources to help manufacturers restart safely and rebuild.
Tools and resources to move forward – fast.
The Critical Role of Audience Intelligence with Eric Enge and Rand FishkinPerficient, Inc.
Things move quickly in marketing. How do you identify what your customers need and how you can help? Now more than ever, audience intelligence is the key.
Audience intelligence is about understanding your target customers, their needs, what resonates with them, and how you can reach them. Eric Enge (Digital Marketing Principal, Perficient) and Rand Fishkin (Co-Founder & CEO, SparkToro) discussed this topic live on May 7, 2020. Watch to hear tactics for gaining a better understanding of your customers, how to use audience intelligence to optimize your marketing now, and more.
Cardtronics, the global leader in ATM deployment and management, decided to retire its on-premises Hyperion solution to gain the operational efficiencies, features, and functionality provided by a best-in-class cloud solution.
Cardtronics chose Oracle EPM Cloud including Financial Consolidation and Close, Planning, Management Reporting, Account Reconciliation, Enterprise Data Management, as well as Oracle Analytics Cloud.
In this video, project owner Richard Ng, director, financial systems, Cardtronics, discusses the migration to Oracle EPM Cloud including:
Multi-release 18-month deployment schedule across multiple countries
Benefits of a global Chart of Accounts for ERP and EPM
Seamless integration across ERP Cloud, HCM Cloud, and EPM Cloud
Preparing for Project Cortex and the Future of Knowledge ManagementPerficient, Inc.
Microsoft has turned traditional enterprise content management on its head with its recent announcement of Project Cortex.
Project Cortex uses advanced artificial intelligence to harness collective knowledge from across the enterprise and automatically organize it into shared topics like projects, products, processes, and customers. Using AI, Cortex creates a knowledge network based on relationships among topics, content, and people and delivers it in the apps you use every day – Office, Outlook, and Teams.
This webinar examined Project Cortex in more detail, including:
• What is Project Cortex?
• Why is Project Cortex different than other knowledge network projects previously introduced?
• How does incorporating AI and automation change the game?
• What is possible with Project Cortex?
• What can you do to prepare?
Utilizing Microsoft 365 Security for Remote Work Perficient, Inc.
With an increasingly mobile workforce, and the spread of shadow IT, the rapid rise of cybercrime - companies must find unique ways to effectively manage their sprawling SaaS portfolio.
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
Builder.ai Founder Sachin Dev Duggal's Strategic Approach to Create an Innova...Ramesh Iyer
In today's fast-changing business world, Companies that adapt and embrace new ideas often need help to keep up with the competition. However, fostering a culture of innovation takes much work. It takes vision, leadership and willingness to take risks in the right proportion. Sachin Dev Duggal, co-founder of Builder.ai, has perfected the art of this balance, creating a company culture where creativity and growth are nurtured at each stage.
SAP Sapphire 2024 - ASUG301 building better apps with SAP Fiori.pdfPeter Spielvogel
Building better applications for business users with SAP Fiori.
• What is SAP Fiori and why it matters to you
• How a better user experience drives measurable business benefits
• How to get started with SAP Fiori today
• How SAP Fiori elements accelerates application development
• How SAP Build Code includes SAP Fiori tools and other generative artificial intelligence capabilities
• How SAP Fiori paves the way for using AI in SAP apps
State of ICS and IoT Cyber Threat Landscape Report 2024 previewPrayukth K V
The IoT and OT threat landscape report has been prepared by the Threat Research Team at Sectrio using data from Sectrio, cyber threat intelligence farming facilities spread across over 85 cities around the world. In addition, Sectrio also runs AI-based advanced threat and payload engagement facilities that serve as sinks to attract and engage sophisticated threat actors, and newer malware including new variants and latent threats that are at an earlier stage of development.
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
Rise in volumes of AI-powered cyberattacks
Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
Vulnerability exploit attempts on CVEs
Attacks on counties – USA
Expansion of bot farms – how, where, and why
In-depth analysis of the cyber threat landscape across North America, South America, Europe, APAC, and the Middle East
Why are attacks on smart factories rising?
Cyber risk predictions
Axis of attacks – Europe
Systemic attacks in the Middle East
Download the full report from here:
https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
Securing your Kubernetes cluster_ a step-by-step guide to success !KatiaHIMEUR1
Today, after several years of existence, an extremely active community and an ultra-dynamic ecosystem, Kubernetes has established itself as the de facto standard in container orchestration. Thanks to a wide range of managed services, it has never been so easy to set up a ready-to-use Kubernetes cluster.
However, this ease of use means that the subject of security in Kubernetes is often left for later, or even neglected. This exposes companies to significant risks.
In this talk, I'll show you step-by-step how to secure your Kubernetes cluster for greater peace of mind and reliability.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Epistemic Interaction - tuning interfaces to provide information for AI supportAlan Dix
Paper presented at SYNERGY workshop at AVI 2024, Genoa, Italy. 3rd June 2024
https://alandix.com/academic/papers/synergy2024-epistemic/
As machine learning integrates deeper into human-computer interactions, the concept of epistemic interaction emerges, aiming to refine these interactions to enhance system adaptability. This approach encourages minor, intentional adjustments in user behaviour to enrich the data available for system learning. This paper introduces epistemic interaction within the context of human-system communication, illustrating how deliberate interaction design can improve system understanding and adaptation. Through concrete examples, we demonstrate the potential of epistemic interaction to significantly advance human-computer interaction by leveraging intuitive human communication strategies to inform system design and functionality, offering a novel pathway for enriching user-system engagements.
Smart TV Buyer Insights Survey 2024 by 91mobiles.pdf91mobiles
91mobiles recently conducted a Smart TV Buyer Insights Survey in which we asked over 3,000 respondents about the TV they own, aspects they look at on a new TV, and their TV buying preferences.
2. 2
ABOUT PERFICIENT
Perficient is the leading digital transformation
consulting firm serving Global 2000 and
enterprise customers.
With unparalleled information technology, management
consulting, and creative capabilities, Perficient and its
Perficient Digital agency deliver vision, execution, and
value with outstanding digital experience, business
optimization, and industry solutions.
3. 3
PERFICIENT PROFILE
Founded in 1997
Public, NASDAQ: PRFT
2015 revenue $473.6 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte,
Chattanooga, Chicago, Cincinnati, Columbus,
Dallas, Denver, Detroit, Fairfax, Houston,
Indianapolis, Lafayette, Milwaukee, Minneapolis,
New York City, Northern California, Oxford (UK),
Southern California,
St. Louis, Toronto
Global delivery centers in China and India
>2,800 colleagues
Dedicated solution practices
~90% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards
4. 4
AGENDA
• Case Entry
– Duplicate Search
– Various Data Points
– Generating Narratives
– Generating Letters
• Case Reporting
– Individual Case Safety Reporting
• MedWatch
• CIOMS-I
• E2B(R3)
– Submission Tracking
• Case Management
– Workflow
– Worklists
– Dashboards
• Ad Hoc Reports
– Case Data Analysis
– Case Line Listing
• Periodic Reporting
– ICH PSUR/PBRER
– NDA Periodic
5. 5
ARGUS SAFETY SYSTEM
• Io was a mortal woman and lover of Zeus
• Zeus' wife, Hera, was terribly jealous and
Zeus fearing for Io's life turned her into a
heifer to escape Hera's gaze
• But Hera was smart and knowing of this
deception, requested Io the heifer as a
present
• She then sent the heifer to her dedicated
servant Argus Panoptes the all-seeing
giant who has been described as having
100 hundred eyes on his body which
allowed him to keep a vigilant watch on Io
the Heifer
7. 7
The [Search] button takes the information entered and queries the entire
database for previously entered and matching cases to allow for the addition of
F/U information
CASE ENTRY
8. 8
A list of potential duplicate cases appear below so that you can fish through the
list opening those that you think are duplicate and either enter F/U or reject the
candidate and move to the next for review
CASE ENTRY
9. 9
The General tab contains entry fields for the reporter information, case
categorizations and initial & F/U records for the case
CASE ENTRY
10. 10
GENERAL TAB
• The General Tab contains all of the general information in the case. Initial reporting
dates are captured in the Initial Received Date field.
• Follow-ups are dictated by the addition of follow-up records in the Follow-ups box.
11. 11
The Patient tab contains the demographic information on the patient of interest
and allows for the recording of historical products, conditions or procedures
CASE ENTRY
12. 12
Medically Confirmed is now an explicit field on the screen
This is explicit to E2B(R3), so the health care professional fields in the reporter tabs still
need to be answered appropriately for E2B(R2) (if still in use)
CASE ENTRY
13. 13
The Product tab allows for the capture of indications and the specifics around
the product administration
CASE ENTRY
15. 15
The Event tab contains the details for the
event of interest in the case.
CASE ENTRY
16. 16
The system is loaded with a
rudimentary but effective
dictionary browser for both the
MedDRA and WHO Drug
dictionaries
CASE ENTRY
17. 17
A case may have more than one event and
they may be sequenced in accordance with
company rules
CASE ENTRY
18. 18
The Event Assessment sub-tab contains location where the local labeledness,
the core listedness and the reporter and company causality records are stored
with respect to the suspect company product(s) and the events
CASE ENTRY
19. 19
The Analysis tab
contains the case level
assessments and the
various comment and
narrative fields required
in global reporting
CASE ENTRY
20. 20
It is possible to build a comprehensive narrative that will take the information
entered into the case an pull it into a paragraphical explanation of the case data
CASE ENTRY
21. 21
The Activities tab contains records of action items and contact records used
within the case entry/management process
CASE ENTRY
22. 22
The Contacts section also facilitates the generation and sending of letter
templates written in a template manner similar to Auto-Narrative functionality in
Argus
CASE ENTRY
23. 23
The Action Items section contains the ability to assign tasks to other users or
groups so that activities are fully tracked with a start date, due date and
completion date
CASE ENTRY
24. 24
Among other things, the
Additional Information tab
allows for the attachment of
source documentation to the
case and storage directly in
the database (it can also
integrate to Documentum)
CASE ENTRY
25. 25
Once attached, the object is available for direct review within the case
CASE ENTRY
26. 26
CASE REPORTING
The Regulatory Reporting tab contains the critical records documenting the global reporting
needs for the case based on stored and configurable reporting rules per license and country
27. 27
Reports can be displayed while in the case entry form using the hyperlinks. Final reports
are generated only after locking a case
CASE REPORTING
28. 28
The Regulatory Reports can be managed from this screen through routing the report
through a pre-defined workflow, once the final is generated
CASE REPORTING
29. 29
Once Approved the report may be submitted and the submission date documented.
CASE REPORTING
30. 30
The following ICSRs are capable of being produced and tracked within the system:
CASE REPORTING
31. 31
Once the case is locked, the final (non-watermarked) reports are generated. In a global
database (Argus and Argus-J activated), the symbols next to the report name indicate if the
report is a global report or one specific to the local Japanese agency
This functionality allows the stabilization of the case data and finalization of all global
reports without negatively affecting the reporting obligations specific to Japan
CASE REPORTING
32. 32
The following is taken from the Oracle User Guide directly:
CASE REPORTING
33. 33
E2B(R3)
Unlike the ICH E2B(R2) standard, the E2B(R3) standard is an HL7 formatted file for
electronic submission
Argus uses the same Interchange/ESM functionality to generate the E2B(R3) file as it does
for E2B(R2)
A considerable change has been introduced for importing E2B(R3) data into Argus. This
technical solution first translates the R3 data into an R2 format before using the same
Interchange/ESM functionality to import the E2B(R3) file as it does for E2B(R2)
NOTE: The use of both E2B(R2) and R3 simultaneously may mean some case entry work
instructions are required to maintain consistent data transmitted
34. 34
To facilitate data
migrations or complex
integrations or perhaps
even placeholders used in
letter templates, new
custom codelists can be
created and maintained
here.
E2B(R3)
35. 35
To accommodate value differences between R2 and R3, the flexible re-categorization area
has been used to map the values between new R3 fields and existing R2
E2B(R3)
36. 36
Once generated, the E2B report can be viewed from within the application using the E2B
viewer (XML, Decoded or HL7 view)
E2B(R3)
37. 37
eVAERS
Similar to E2B(R3), the CBER required eVAERS report is also available in Argus 8.0; uses
the XML viewer as described above
38. 38
In Argus 8.0.1 the introduction of the Electronic Medical Device Report (eMDR) in HL7
format has been introduced!
eMDR
39. 39
E2B REPORT DISTRIBUTION
The E2B(R2)/R3 and VAERS files are transmitted using the
standard E2B submission mechanism (WorklistBulk E2B
Transmit)
40. 40
Throughout the life of the case, the responsibilities can be shared with various case
processors/managers using the routing and workflow features of Argus
CASE MANAGEMENT
41. 41
You can pass the case through the workflow using the forward
and return buttons as needed…
Bookin
Case
Processing
Review
Reporting
Archive
/Close
F/U
CASE MANAGEMENT
42. 42
Each pass to the next step, places the case into a New Case Worklist so
that case processors/managers can accept the cases into their Open Case
Worklists
CASE MANAGEMENT
43. 43
In general, all of the worklists allow for certain completion of tasks using the sub-menu
from the screen that is contextually sensitive to the worklist being accessed
Worklist New and Open Worklist Action Worklist Reports
CASE MANAGEMENT
44. 44
The Coding Review screen summarizes all of the medical or drug coding required in the
case in a single screen to allow the coder to perform all work without navigating through
the case entry tabs
CASE MANAGEMENT
45. 45
The Medical Review screen summarizes all of the clinically relevant data that is often
used in the formal medical review process. The data is displayed as entry points or…
CASE MANAGEMENT
50. 50
Expedited Reports display in an interactive form and allow easy review of reports and
their statuses
CASE MANAGEMENT
51. 51
You can get a visual representation of where cases are in the workflow using the
dashboard
CASE MANAGEMENT
52. 52
Case Workload status and distribution can be displayed in the system or exported to
Excel
CASE MANAGEMENT
53. 53
AD-HOC REPORTING
Argus has a built-in ad hoc reporting tool that facilitates the generation of line listing and
tabulation reports with relative ease
54. 54
The CDA report allows for the selection of case entered data points to generate tabulated
data
AD-HOC REPORTING
55. 55
The reports can be displayed, memorized or transmitted to others. The data format of the
report can be exported to Excel as well
AD-HOC REPORTING
57. 57
The Line Listing Report allows for the selection of case data to display in linear form
which facilitates tasks like reconciliation
AD-HOC REPORTING
58. 58
Line listing reports
have a major limitation
though, in the display
of multiple rows of data
even when the logic of
the report wishes the
data to be eliminated
from the display.
For example, if my listing wants to display all serious events and a given case has two events (1
serious and 1 non), then both rows display on the report even when I try to restrict it.
However, even with this limitation, the ability to easily generate your own ad hoc reports with
little to no IT assistance is likely worth it!
AD-HOC REPORTING
59. 59
Argus allows for the generation of the listings and tabulations
required in several global periodic reports
You can create “templates” and reuse them or copy from an
old report
PERIODIC REPORTING
60. 60
The report allows for naming, categorization and selection of the agencies to which the
information will be submitted
PERIODIC REPORTING
62. 62
Options for inclusion criteria allow you to tightly focus on the data responsible for the
report
PERIODIC REPORTING
63. 63
The system
allows for the
indication of AEs
of Special Interest
on the report
PERIODIC REPORTING
64. 64
A user can decide what additional fields of information should display on the listing
sections of the report
PERIODIC REPORTING
65. 65
The report also allows for the grouping of the data by certain fields
PERIODIC REPORTING
66. 66
The PBRER tables are also included in the PSUR report as well as a number of summary
tabulations
PERIODIC REPORTING
67. 67
Users can also create their own user defined listings and tabulations using the Case
Listing and Case Data Analysis reports from Argus and then include them in the periodic
report
PERIODIC REPORTING
68. 68
Once developed, the report can be drafted, reviewed and submitted through the interface
but the work of the drafting is the report is offset to the transactional server thus freeing
processing speed for the application server
PERIODIC REPORTING
69. 69
Once printed in FINAL mode, all cases included in the periodic report receive a
submission record in their case for clear inclusion in the report and its tracking
PERIODIC REPORTING
70. 70
In Argus 8.0, the system is integrated to the BI Publisher aspect of Oracle OBIEE
Out of the box, three BI reports are given and available for full modification:
DSUR
PSUR
PMAR
BI PUBLISHER PERIODIC REPORTING
71. 71
The data models are fully available in the BI Publisher tool
BI PUBLISHER PERIODIC REPORTING
72. 72
The reports that make up the final DSUR report are all
available for viewing/modification as well
BI PUBLISHER PERIODIC REPORTING
73. 73
SUMMARY
• Argus provides a sleek interface allowing for the rapid entry, management and
reporting of individual case safety data.
• HL7 file reporting
– E2B(R3)
– eVAERS
– Argus 8.0.1 includes eMDR reports
• Integrated to BI Publisher
• Argus provides interfaces for the generation of ad hoc listings and tabulations with
little IT support
• Periodic reports are relatively easy to build and track within the system
• Dashboards allow for the comfortable display of case, report and management
information to help your safety team stay organized
74. 74
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