This document discusses the challenges that banks face in managing large amounts of data for regulatory stress tests. It notes that stress tests require data from up to 100 different systems across a bank and analyzing this data at specific points in time is difficult. The large number of scenarios and environments needed for stress tests also contributes to data management challenges. Banks currently rely heavily on manual processes for stress testing which can lead to data issues and reduced productivity. The document introduces the concept of data virtualization as a potential solution to help banks address these problems by improving data access, reducing storage costs, and allowing for more automated processes.
In the past decade, there has been a significant increase in the use of Data Monitoring
Committees (DMC) and Adaptive Designs (AD) in clinical trials. While the monitoring of safety
data by a formal committee is not required for all clinical trials, it has become the norm to have
a formal DMC conduct periodic safety reviews for any controlled trial that evaluates treatments
intended to prolong life or reduce risk of major adverse health outcomes, or for trials that
compare rates of mortality or major morbidity. Confirmatory, pivotal, and adaptive design trials
have more complex operational issues requiring an external and independent DMC. The DMC
may have access to unblinded interim data, be required to make expert recommendations
about how the trial should continue, and then ensure that planned adaptations are
implemented as outlined in the protocol without involving the sponsor or exposing it to
unblinded data or results.
This added complexity creates a challenge and a question: how can the DMC, statisticians, and
sponsor effectively communicate, share blinded and unblinded data, perform analyses, and
implement adaptations without introducing operational bias or compromising the integrity of
the trial? One solution is to utilize a sophisticated computer system that can provide the
security and necessary firewalls to ensure that interim data is only accessible to those it is
intended for, that the rules and processes outlined in the protocol and DMC charter are
enforced, and that communication between the DMC and sponsor is effectively facilitated while
protecting the integrity of the trial and preventing the introduction of operational bias.
The system must also provide an audit trail that tracks “who saw what and when” providing
evidence to regulatory authorities that the protocol was strictly followed with a minimal
possibility of bias. This white paper describes the computer system, ACES, which Cytel has built,
that makes all of this possible. ACES (Access Control Execution System) has been purpose-built
to address the operational complexities inherent in adaptive design and pivotal clinical trials.
Shopping for a practice management solution can be a little overwhelming. You have lots of systems to choose from, so how do you decide which one will answer your total practice needs best? What is the difference between All-in-one platforms vs. Stand-alone programs. Or the difference between cloud based vs local server solutions. How do I know which type is best suited to my specific office situation and budget? This whitepaper explores it all.
Shedding Some Light on the Insights Lurking in the PMA DatabaseRevital (Tali) Hirsch
May 28, 2016 marked forty years of modern day federal authority over medical devices in the U.S. Not only is this period brief in and of itself, but it’s also shorter by half compared to the duration of federal authority over pharmaceuticals, which began with the Food, Drug and Cosmetics Act of 1938. In the past several years the FDA has been the target of much criticism with regards to the approval of high-risk medical devices. Some of that critique is likely merited, but it is important to keep in mind that the medical device arm of the FDA is a work-in-progress that has had considerably less time to invent itself in the larger context of history.
This paper compares and contrasts different stakeholders’ perspectives and takes a deeper dive into the data. In doing so, this paper outlines practical changes and enhancements to the PMA database that can be carried out in the immediate present to increase transparency between the FDA and Industry.
The deeper dive also identifies several potential avenues for follow-on research, including PMAs that do not reach a positive conclusion and PMAs that are sponsored by early-stage and/or inexperienced filers. Insights from such research may hold the key to longer-term regulatory process improvements within the existing framework to promote high-risk medical device innovation and shorten these devices’ time-to-market without compromising the higher standards of the domestic regulatory system or the safety of patients.
Improve Patient Care and Reduce IT Costs with Vendor Neutral Archiving and Cl...EMC
This paper illustrates how Vendor Neutral Archive combined Atmos cloud storage enable healthcare organizations to break down PACS silos to reduce storage and archive costs, and provide secure, anywhere access to medical images on any device at the point of care.
Data Center Critical Infrastructure Risk and Vulnerabilities- Impact to Capit...Vincent Pelly
We at Citihub believe in the importance of having an end-to-end Business Continuity solution that includes not only a tested and validated data center and infrastructure design, but also the ability to provide staff with remote access to the key applications needed to continue operations.
Our recently published white paper provides senior executives with an overview of Disaster Recovery preparedness as well as outlining the potential risks and vulnerabilities that exist in critical infrastructure, specifically in the New York metropolitan area. Read the technical white paper “Data Center Infrastructure Risk and Vulnerabilities” to become aware of critical details that may not be covered in your business Disaster Recovery plans.
In the past decade, there has been a significant increase in the use of Data Monitoring
Committees (DMC) and Adaptive Designs (AD) in clinical trials. While the monitoring of safety
data by a formal committee is not required for all clinical trials, it has become the norm to have
a formal DMC conduct periodic safety reviews for any controlled trial that evaluates treatments
intended to prolong life or reduce risk of major adverse health outcomes, or for trials that
compare rates of mortality or major morbidity. Confirmatory, pivotal, and adaptive design trials
have more complex operational issues requiring an external and independent DMC. The DMC
may have access to unblinded interim data, be required to make expert recommendations
about how the trial should continue, and then ensure that planned adaptations are
implemented as outlined in the protocol without involving the sponsor or exposing it to
unblinded data or results.
This added complexity creates a challenge and a question: how can the DMC, statisticians, and
sponsor effectively communicate, share blinded and unblinded data, perform analyses, and
implement adaptations without introducing operational bias or compromising the integrity of
the trial? One solution is to utilize a sophisticated computer system that can provide the
security and necessary firewalls to ensure that interim data is only accessible to those it is
intended for, that the rules and processes outlined in the protocol and DMC charter are
enforced, and that communication between the DMC and sponsor is effectively facilitated while
protecting the integrity of the trial and preventing the introduction of operational bias.
The system must also provide an audit trail that tracks “who saw what and when” providing
evidence to regulatory authorities that the protocol was strictly followed with a minimal
possibility of bias. This white paper describes the computer system, ACES, which Cytel has built,
that makes all of this possible. ACES (Access Control Execution System) has been purpose-built
to address the operational complexities inherent in adaptive design and pivotal clinical trials.
Shopping for a practice management solution can be a little overwhelming. You have lots of systems to choose from, so how do you decide which one will answer your total practice needs best? What is the difference between All-in-one platforms vs. Stand-alone programs. Or the difference between cloud based vs local server solutions. How do I know which type is best suited to my specific office situation and budget? This whitepaper explores it all.
Shedding Some Light on the Insights Lurking in the PMA DatabaseRevital (Tali) Hirsch
May 28, 2016 marked forty years of modern day federal authority over medical devices in the U.S. Not only is this period brief in and of itself, but it’s also shorter by half compared to the duration of federal authority over pharmaceuticals, which began with the Food, Drug and Cosmetics Act of 1938. In the past several years the FDA has been the target of much criticism with regards to the approval of high-risk medical devices. Some of that critique is likely merited, but it is important to keep in mind that the medical device arm of the FDA is a work-in-progress that has had considerably less time to invent itself in the larger context of history.
This paper compares and contrasts different stakeholders’ perspectives and takes a deeper dive into the data. In doing so, this paper outlines practical changes and enhancements to the PMA database that can be carried out in the immediate present to increase transparency between the FDA and Industry.
The deeper dive also identifies several potential avenues for follow-on research, including PMAs that do not reach a positive conclusion and PMAs that are sponsored by early-stage and/or inexperienced filers. Insights from such research may hold the key to longer-term regulatory process improvements within the existing framework to promote high-risk medical device innovation and shorten these devices’ time-to-market without compromising the higher standards of the domestic regulatory system or the safety of patients.
Improve Patient Care and Reduce IT Costs with Vendor Neutral Archiving and Cl...EMC
This paper illustrates how Vendor Neutral Archive combined Atmos cloud storage enable healthcare organizations to break down PACS silos to reduce storage and archive costs, and provide secure, anywhere access to medical images on any device at the point of care.
Data Center Critical Infrastructure Risk and Vulnerabilities- Impact to Capit...Vincent Pelly
We at Citihub believe in the importance of having an end-to-end Business Continuity solution that includes not only a tested and validated data center and infrastructure design, but also the ability to provide staff with remote access to the key applications needed to continue operations.
Our recently published white paper provides senior executives with an overview of Disaster Recovery preparedness as well as outlining the potential risks and vulnerabilities that exist in critical infrastructure, specifically in the New York metropolitan area. Read the technical white paper “Data Center Infrastructure Risk and Vulnerabilities” to become aware of critical details that may not be covered in your business Disaster Recovery plans.
EMC Isilon: A Scalable Storage Platform for Big DataEMC
This white paper provides insights into EMC Isilon's shared storage approach, covering a wide range of desired characteristics including increased efficiency and reduced total cost.
White paper: Functional Requirements for Enterprise Clinical Data Management:...Carestream
As healthcare organizations plan for the future growth and integration of clinical
data into their IT ecosystems, it’s crucial to clearly define the functional requirements spanning the needs of users across the enterprise. This white paper provides an overview of the key functional requirements. To learn more visit carestream.com/clinical-collaboration
Maintaining Credit Quality in Banks and Credit UnionsLibby Bierman
In this session, Sageworks presented different ways that people in the bank can curb credit risk in an effort to maintain and improve credit quality of the portfolio.
Whitepaper : Building a disaster ready infrastructureJake Weaver
It’s not just hurricanes, fire or other natureal disasters that can bring a business to its knees. Everyday problems such as bad software, misconfigured networks, hardware failures or power outages are much more common. In fact, power failures accounted for nearly half of the declared disasters reported in a recent survey conducted by Forrester
The elements of the development plan
Elements of the quality plan
Development and quality plans for small and for internal projects
Software development risks a
Legal Firms and the Struggle to Protect Sensitive DataBluelock
Survey results from the 2016 IT Disaster Recovery Planning and Preparedness Survey | Bluelock commissioned with ALM to asses the current state of the legal industry's IT disaster recovery (DR) preparedness, pressures and confidence.
Legal Firms and the Struggle to Protect Sensitive DataKayla Catron
Survey results from the 2016 IT Disaster Recovery Planning and Preparedness Survey | Bluelock commissioned with ALM to asses the current state of the legal industry's IT disaster recovery (DR) preparedness, pressures and confidence.
A systematic characterization and a non-systematic examination of risk & outcome in clinical trial outsourcing:
1. Technical Risk
2. Regulatory Risk
3. Commercial Risk
4. Decision Risk
A decision risk challenge is posed: if you were presented with a foolproof way to half your investment and get the same outcome would you take it? The answer is no you wouldn’t … or more specifically you don’t. At least until you’ve finished my talk and then you'll change ... maybe!
Best Practices and Points to Consider for Small-Medium Bio-Pharma CompaniesCovance
Small to medium sized companies face a host of unique challenges in the management of drug safety as they prepare to launch and sustain their products. Lack of clinical, safety and regulatory resources and expertise, along with inadequate technology infrastructure can create significant challenges and risks when advancing products through the life cycle. Find out how you can help your organizations overcome some common obstacles, learn from best practices and efficiently comply with global pharmacovigilance requirements.
The EU's Circular Economy Package is a big opportunity to capture the value of recyclable European metals. But what needs to happen? We explain our 5 recommendations here.
NEW FRONTIERS Building Blocks of the Future SeminarNEW FRONTIERS
NEW FRONTIERS Building Blocks of the Future seminar held on 23rd September 2010 at CUBE, Manchester.
Bringing together diverse elements of the "built environment supply chain", from material chemists to architects and designers, the seminar explored new and evolving chemistry solutions and materials for the future of sustainable buildings.
The speakers were Dr. Richard Miller, Head of Sustainability at the Technology Strategy Board, Phil Green of BASF and Dr. Troy Manning of NSG Group, Pilkington.
For further information visit www.NEWFRONTIERS.uk.com
EMC Isilon: A Scalable Storage Platform for Big DataEMC
This white paper provides insights into EMC Isilon's shared storage approach, covering a wide range of desired characteristics including increased efficiency and reduced total cost.
White paper: Functional Requirements for Enterprise Clinical Data Management:...Carestream
As healthcare organizations plan for the future growth and integration of clinical
data into their IT ecosystems, it’s crucial to clearly define the functional requirements spanning the needs of users across the enterprise. This white paper provides an overview of the key functional requirements. To learn more visit carestream.com/clinical-collaboration
Maintaining Credit Quality in Banks and Credit UnionsLibby Bierman
In this session, Sageworks presented different ways that people in the bank can curb credit risk in an effort to maintain and improve credit quality of the portfolio.
Whitepaper : Building a disaster ready infrastructureJake Weaver
It’s not just hurricanes, fire or other natureal disasters that can bring a business to its knees. Everyday problems such as bad software, misconfigured networks, hardware failures or power outages are much more common. In fact, power failures accounted for nearly half of the declared disasters reported in a recent survey conducted by Forrester
The elements of the development plan
Elements of the quality plan
Development and quality plans for small and for internal projects
Software development risks a
Legal Firms and the Struggle to Protect Sensitive DataBluelock
Survey results from the 2016 IT Disaster Recovery Planning and Preparedness Survey | Bluelock commissioned with ALM to asses the current state of the legal industry's IT disaster recovery (DR) preparedness, pressures and confidence.
Legal Firms and the Struggle to Protect Sensitive DataKayla Catron
Survey results from the 2016 IT Disaster Recovery Planning and Preparedness Survey | Bluelock commissioned with ALM to asses the current state of the legal industry's IT disaster recovery (DR) preparedness, pressures and confidence.
A systematic characterization and a non-systematic examination of risk & outcome in clinical trial outsourcing:
1. Technical Risk
2. Regulatory Risk
3. Commercial Risk
4. Decision Risk
A decision risk challenge is posed: if you were presented with a foolproof way to half your investment and get the same outcome would you take it? The answer is no you wouldn’t … or more specifically you don’t. At least until you’ve finished my talk and then you'll change ... maybe!
Best Practices and Points to Consider for Small-Medium Bio-Pharma CompaniesCovance
Small to medium sized companies face a host of unique challenges in the management of drug safety as they prepare to launch and sustain their products. Lack of clinical, safety and regulatory resources and expertise, along with inadequate technology infrastructure can create significant challenges and risks when advancing products through the life cycle. Find out how you can help your organizations overcome some common obstacles, learn from best practices and efficiently comply with global pharmacovigilance requirements.
The EU's Circular Economy Package is a big opportunity to capture the value of recyclable European metals. But what needs to happen? We explain our 5 recommendations here.
NEW FRONTIERS Building Blocks of the Future SeminarNEW FRONTIERS
NEW FRONTIERS Building Blocks of the Future seminar held on 23rd September 2010 at CUBE, Manchester.
Bringing together diverse elements of the "built environment supply chain", from material chemists to architects and designers, the seminar explored new and evolving chemistry solutions and materials for the future of sustainable buildings.
The speakers were Dr. Richard Miller, Head of Sustainability at the Technology Strategy Board, Phil Green of BASF and Dr. Troy Manning of NSG Group, Pilkington.
For further information visit www.NEWFRONTIERS.uk.com
In process improvement, a SIPOC (sometimes COPIS) is a tool that summarizes the inputs and outputs of one or more processes in table form. The acronym SIPOC stands for Suppliers, Inputs, Process, Outputs, and Customers which form the columns of the table.
Whitepaper des Herstellers zum Thema Collect, Transform,Generate and Test
MetaSuite and HP Quality Center Enterprise, generating Test Data
from any data source from any platform, including mainframe
Kontakt: http://www.Minerva-SoftCare.de
Rate of Return for Stocks and BondsFIN571Running he.docxmakdul
Rate of Return for Stocks and Bonds
FIN/571
Running head: RATE OF RETURN FOR STOCKS AND BONDS
1
RATE OF RETURN FOR STOCKS AND BONDS
2
Rate of Return for Stocks and Bonds
This paper will discuss how capital asset pricing model (CAPM), weighted average capital cost (WACC) and flotation costs influence the financial decision making with the capital budgeting process. Through these calculations, a company can better understand how the impact of debt and equity has on their capital structure. These concepts will also allow financial managers within an organization to make sound investment decisions when determining whether or not to invest in a particular project during the capital budgeting process. As a part of this assignment, calculations of the problems involving stock valuation, total return, CAPM, WACC, and flotation costs listed in a separate document under "Calculations – Rate of Returns for Stocks and Bonds."
Capital Asset Pricing Model (CAPM)
CAPM typically measures the association between the risk and expected return of a stock portfolio. In this paper, we will discuss how CAPM is used to estimate the cost of equity capital and the expected rate of return. There is a particular type of symmetry when we are looking at the cost of capital to a company compared to the expected return on a stock. Companies may use this measure in determining how much equity they will use to fund a capital budget project. In the calculation assignment, we calculate the expected rate of return through CAPM. The expected rate of return equals the risk-free rate plus the beta times the difference of the expected market rate and the risk-free rate. We can also use the formula to estimate the cost of equity. The cost of equity can then be used to the beta risk of the project and what the discount rate on the cash flow of the project show be.
Weighted Average Capital Cost (WACC)
"The weighted average cost of capital (WACC) is the rate of return that the providers of a company's capital require, weighted according to the proportion each element bears to the total pool of capital." (Qatar Financial Center, 2014) It provides a measure similar to the CAPM, which the correct discount rate on cash flow and it also provides the rate of interest of capital. Many financial managers used this measure to make investment decisions while finding the correct capital structure for their company. In the WACC portion of the calculation assignment, we were asked to find the WACC which is the weight of equity within the capital structure multiply by the cost of equity times the inverse of the tax rate plus the weight of debt within the capital structure multiply by the cost of debt. By determining WACC, financial managers can analyze the value the project. The expected rate of return of WACC can be used to determine the risk and the capital structure of the company’s existing assets. This expected rate of return can then be used to calculate NPV to either ...
Change has always been a constant in the financial industry but the recent financial crisis triggered an unprecedented rise in that rate of change. Today, increased regulation, greater demands for transparency, and new business channels require financial institutions to constantly be in reactive mode.
Financial institution executives realize the increasing pace of change is not temporary. They understand that this is a “new normal” that they must plan and prepare for. And they know that proactively developing a sound strategy for dealing with constant change begins with an honest look at the institution’s ability to deal with change.
The only way to improve change capacity is to build a strong foundation based in technology that is specifically designed to manage constant transformation.
Planning and implementing a VMware disaster recovery (DR) plan is not a task to be taken lightly. Download this new white paper that will function as a checklist, that can guide you on the creation of a top-notch VMware disaster recovery plan.
Ch cie gra - stress-test-diffusion-model-and-scoring-performanceC Louiza
The 2008 crisis has demonstrated the importance of conducting stress tests to prevent banking failure. This exercise has also a significant impact on banks’ capital, organization and image.
This paper aims to provide a methodology that diffuses the stress applied on a credit portfolio while taking into account risk and performance for each rating category.
The content is structured in three parts:
The importance of stress testing and the impacts on reputation
Methodology for a dynamic stress diffusion model
Study on a real SME portfolio showing that the model designed in this paper captures relationship between Gini index and the stress diffusion
The Management of Critical Spares in the Electric & Gas Utility IndustryScottMadden, Inc.
The subject of “How to Manage Critical Spares” has been of interest to members of the ScottMadden-led Utility Materials Management Benchmarking Consortium for several years. However, no common, industry-wide accepted definition of “Critical Spares” exists at this time. This report provides a sample of the results of a survey conducted by ScottMadden, Inc., regarding the management of Critical Spares by electric & gas utilities in North America.
Predictive Maintenance - A Smart Solution to Maintain your Equipment!AndySmith774959
Manufacturing industries strive for maximizing asset availability but face lots of challenges while implementing. Ineffective maintenance strategies can cause reductions, ranging from 5% to 20%, in the overall productive capacity of plants. The same study also suggested that unplanned downtime causes companies to incur around $50 billion annually. Companies worldwide are trying to figure out the optimum frequency of servicing their equipment.
Microsoft India - Total Economic Impact of Microsoft SQL Server 2008 Upgrade ...Microsoft Private Cloud
Conducting in-depth interviews with an existing SQL customer that upgraded to SQL Server 2008, Forrester found that the organization achieved benefits, some easily measured for this ROI study and others, equally as valuable, that could not be quantified. Specifically, the benefits fall into the following categories: 1) avoided adding SQL Server 2008 servers – license and hardware savings; 2) avoided adding storage; 3) eliminated third-party software; 4) avoided hiring additional IT employees; 5) increased user productivity – business and IT; 6) improved database performance
and provided enhanced features; 7) improved data security; and 8) improved working experience for the database administration team. Only the first five benefits were quantified as part of the ROI
analysis. To fully understand the potential effect on their organizations, readers should consider all benefits, whether or not they could be quantified for this study.