The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
Interactive Discussion Based on Data from Avoca’s 2013 Industry Research DIA Forum
June 24, 2013
Jane Tucker presents on risk management in clinical trials. She discusses the basic risk management methodology of identifying risks, analyzing them, prioritizing significant risks, and planning mitigation actions. Tucker also covers how to structure effective risk statements and documents risks in a log or register. Participants learn that risk management adds benefit by focusing resources on the greatest risks and ensuring key tasks are completed.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
This document discusses managing risk and ensuring effective oversight in outsourced clinical trials. It provides an overview of a forum on this topic, including background challenges in quality management where there is sometimes a disconnect between sponsor and CRO perceptions of quality. The document also covers sections on proactive quality management and effective oversight, risk-sharing between sponsors and providers, and risk assessment and management. Key themes discussed include operationalizing approaches to setting and communicating expectations, which can drive consistency and increase quality.
This Presentation is about why CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.
Topics covered:
1.Importance of CRO/Vendor oversight in clinical trial management.
2. Identify the ways to integrate a risk-based approaches to CRO/Vendor oversight.
3. Developing a CRO/Vendor oversight plan with appropriate KPIs/metrics to be measured.
4. Use of tools and technology for accurate and timely reporting.
Sponsor and provider perceptions on managing clinical development risk were surveyed. Key findings include:
- Risk assessment is typically a joint sponsor-provider process involving project management, operations, and quality assurance teams.
- Common risks assessed are patient enrollment, vendor performance, and data quality.
- Risk-based monitoring is used more frequently by top 20 sponsors than non-top 20, especially in late phases. Frequency of site visits and data monitoring are most adjusted.
- Risk approaches have yielded some efficiency and quality benefits, though sponsors report less satisfaction with CROs than CROs report with themselves.
Jane Tucker presents on risk management in clinical trials. She discusses the basic risk management methodology of identifying risks, analyzing them, prioritizing significant risks, and planning mitigation actions. Tucker also covers how to structure effective risk statements and documents risks in a log or register. Participants learn that risk management adds benefit by focusing resources on the greatest risks and ensuring key tasks are completed.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
This document discusses managing risk and ensuring effective oversight in outsourced clinical trials. It provides an overview of a forum on this topic, including background challenges in quality management where there is sometimes a disconnect between sponsor and CRO perceptions of quality. The document also covers sections on proactive quality management and effective oversight, risk-sharing between sponsors and providers, and risk assessment and management. Key themes discussed include operationalizing approaches to setting and communicating expectations, which can drive consistency and increase quality.
This Presentation is about why CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.
Topics covered:
1.Importance of CRO/Vendor oversight in clinical trial management.
2. Identify the ways to integrate a risk-based approaches to CRO/Vendor oversight.
3. Developing a CRO/Vendor oversight plan with appropriate KPIs/metrics to be measured.
4. Use of tools and technology for accurate and timely reporting.
Sponsor and provider perceptions on managing clinical development risk were surveyed. Key findings include:
- Risk assessment is typically a joint sponsor-provider process involving project management, operations, and quality assurance teams.
- Common risks assessed are patient enrollment, vendor performance, and data quality.
- Risk-based monitoring is used more frequently by top 20 sponsors than non-top 20, especially in late phases. Frequency of site visits and data monitoring are most adjusted.
- Risk approaches have yielded some efficiency and quality benefits, though sponsors report less satisfaction with CROs than CROs report with themselves.
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
This document summarizes a presentation on sponsor-CRO relationships given by David Selkirk. It outlines the pressures facing both pharmaceutical sponsors and CROs that are driving increased strategic partnerships between the two. These pressures include patent cliffs reducing drug revenues, increased competition, and the need for global clinical trial networks. The relationship has evolved from sponsors using CROs for occasional contract work to more long-term strategic alliances where both share planning and goal alignment. The future is expected to see continued outsourcing to large CRO strategic partners, more CRO specialization, and a focus on emerging markets, biosimilars, and patient-centered outcomes research.
The World Congress Summit on Risk-Based Monitoring and the Quality Risk Manag...WorldCongress
This Summit offers pharmaceutical and medical device delegates concrete examples of how to build a framework and methodology for a risk-based monitoring (RBM) program that is part of an overall risk management approach to study planning and oversight. One of the biggest challenges of implementation is overcoming resistance to change as no organization wants to be the first. For that reason, Summit faculty share change management strategies for people, processes, and technology that led to the effective implementation of their RBM programs. The Site’s perspective, assessing readiness for change and providing support during the change process must not be overlooked. Strategies to partner with Sites to achieve stronger connectivity will also be discussed.
This Risk Based Monitoring - Impact on Sites overview presentation, on targeted topics, was delivered to the ACRP Raleigh - Durham Chapter's Annual Conference in 2013.
The document discusses using gamification strategies to incentivize desired behaviors at clinical trial sites. It defines gamification as leveraging people's innate desire to compete and be recognized. The document outlines common behaviors to target, such as patient adherence and timeliness of data entry. It recommends using real-time reporting in an eClinical system to display metrics like leaderboards tracking performance. Finally, it provides some example gamification implementations, such as rewarding the clinical site with the highest patient compliance percentage or fastest data entry times.
Despite increased industry interest in risk-based monitoring (RBM) for clinical trials, most organizations have yet to develop standard operating procedures for its use. Those who have implemented RBM still face challenges related to resources, quality, and change management. As clinical research organizations play a central role in data monitoring, they are well-positioned to address barriers to RBM adoption and help standardize its application across stakeholders. Key factors for RBM success include early CRO involvement in trial planning, cross-functional collaboration, and use of advanced technology platforms to facilitate remote monitoring and risk assessment.
Pharma-CRO Relationships Managing Risk A Lawyer\'s Viewalbinpaul
The document discusses sponsor-CRO relationships and managing risks when outsourcing clinical trials to contract research organizations (CROs). It defines CROs and site management organizations (SMOs) and their roles. It also discusses selecting CROs, establishing metrics to measure performance, managing personnel changes and communications, and proactively avoiding and resolving disputes. The key aspects are selecting the right CRO based on expertise and compatibility, establishing metrics for accountability and continuous improvement, and clear communications and dispute resolution processes to facilitate the relationship.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
Risk based monitoring presentation into what Risk Based Monitoring (RBM) is all about. The value of getting it right, and the risks of getting it wrong. We look at the Triumph Research Intelligence (TRI) approach to RBM, and the TRI solution to RBM. An insight into the Future of Visual OPRA is given.
The Risk-Based Monitoring (RBM) discussion is moving away from one focused on changing monitoring methods and reducing source document verification (SDV) to 'intelligent monitoring.' Learn why here!
How are you doing your risk management in QMS? Or risk management in NPD (new product design) process? Here are simple 5 steps in this presentation.
More detailed information and templates are available at:
https://www.qualcy.com/blog/quality-risk-management-qms/
How much does it cost to launch and commercialize a companion diagnostic test?Diaceutics Group
We ask four senior executives to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. View the infographic to see what they came up with.
We defined low end as a follow on diagnostic product where a similar test exists in the market and a high end test which is a new biomarker (needing to establish novel clinical utility), or a new platform likely to be in oncology, a chronic disease like rheumatoid arthritis or a range of infectious markers requiring panel performance.
Source http://www.diaceutics.com/mystery-solved-what-cost-develop-and-launch-diagnostic#sthash.ryk5zoEa.dpuf
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
White Paper: From Here to Risk-Based MonitoringFreedom Monk
This white paper discusses risk-based monitoring approaches for clinical trials. It provides a framework for comparing different risk-based monitoring solutions, focusing on tailoring the approach for each individual study, looking backward to correct past errors, monitoring in real-time, ensuring future success through error prediction and prevention, and planning a successful transition. The paper emphasizes the importance of individualizing monitoring plans for each specific study based on risks, adjusting plans as needed during the study based on observed circumstances, and using metrics and indicators to proactively manage quality and performance in real-time rather than just focusing on detecting errors after the fact.
Dr. Ralf Kaiser discusses challenges and the future of risk-based monitoring in clinical trials. Some key challenges include getting approval from pharmaceutical companies and investigator sites for the new paradigm, training site personnel on new technical approaches, and ensuring compatible systems between CROs and sponsors. Over time, Dr. Kaiser envisions a transition to a common global database managed by regulatory authorities where most clinical trials are informed by big data rather than conducted de novo, with only confirmation studies involving limited subjects.
This document provides an overview of ICH Q9 Quality Risk Management. It defines key terms like quality, risk, risk management, and quality risk management. It describes the quality risk management process, which includes risk identification, analysis, evaluation, control, communication, and review. Various risk management tools are also discussed, as well as potential applications of quality risk management in industry and regulatory operations. Challenges of implementing quality risk management concepts are also acknowledged.
Integrating Trial Data Processes Across Functional Areas using Electronic Dat...www.datatrak.com
The document discusses how integrating an electronic data capture (EDC) system across functional areas like clinical monitoring, project management, investigator sites, and clinical data management (CDM) requires changes to processes, roles, and communication. It describes how data collection, recording, monitoring, and cleaning processes need to be re-engineered when transitioning from paper to an electronic system. Implementing an EDC system successfully requires redefining responsibilities and adjusting workflows between these groups to maximize benefits.
Use this template to create your Risk Based Monitoring guideline. Make sure you review this in conjunction with the Risk Based Monitoring in Practice presentation for the best possible result.
The survey found that risk sharing between sponsors and clinical service providers is common, with bonuses and penalties being the most prevalent models. Bonuses and penalties typically range from 2-10% of the contract value. While experiences with risk sharing have been mixed, most respondents found it primarily or generally positive.
Most sponsors and providers reported conducting systematic risk assessments for the majority of their clinical trials. Assessments focus on risks like patient enrollment, vendors, and data quality. They are usually qualitative but sometimes include quantitative elements. Providers are often involved in the assessments.
Assessments frequently lead to risk management measures like reviewing performance plans, capturing additional data, adjusting site numbers or locations, and adding
The document discusses the results of a 2014 survey on the use of data-driven approaches in clinical trials. It finds that while many respondents believe their use of such approaches has advanced in recent years, there is still significant room for improvement. Outsourcing relationships were seen as both promoting and potentially inhibiting their use, by increasing access to data and expertise but also sometimes creating challenges for change management and planning. Overall, the survey highlights opportunities to further apply analytical techniques to optimize clinical development processes and outcomes.
This document summarizes the results of a 2013 survey on managing risk in outsourced clinical trials partnerships. The survey explored different risk-sharing models sponsors and clinical service providers use, how risk is assessed, and whether risk-based management approaches have been successful. Most respondents reported using systematic risk assessments that evaluate risks like enrollment, vendors, data quality, and safety. While risk-based approaches have sometimes increased quality, responses on efficiency were mixed. Sponsors tend to be more satisfied with in-house teams for risk identification and communication compared to service providers like CROs. The document concludes that while executives reported strong understanding of risk management, operational teams could benefit from more training.
Sponsor and provider perceptions differ on satisfaction levels. Sponsors reported lower satisfaction than providers in several areas, including quality. This suggests providers may overestimate the quality of their services from sponsors' perspectives. Risk-sharing models are used more often in strategic relationships than transactional ones. Both sponsors and providers have had primarily positive experiences with guaranteed revenue streams in exchange for commitments. Penalties have drawn more negative responses. Bonuses and penalties tend to be low percentages, under 10%, of contract value.
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
This document summarizes a presentation on sponsor-CRO relationships given by David Selkirk. It outlines the pressures facing both pharmaceutical sponsors and CROs that are driving increased strategic partnerships between the two. These pressures include patent cliffs reducing drug revenues, increased competition, and the need for global clinical trial networks. The relationship has evolved from sponsors using CROs for occasional contract work to more long-term strategic alliances where both share planning and goal alignment. The future is expected to see continued outsourcing to large CRO strategic partners, more CRO specialization, and a focus on emerging markets, biosimilars, and patient-centered outcomes research.
The World Congress Summit on Risk-Based Monitoring and the Quality Risk Manag...WorldCongress
This Summit offers pharmaceutical and medical device delegates concrete examples of how to build a framework and methodology for a risk-based monitoring (RBM) program that is part of an overall risk management approach to study planning and oversight. One of the biggest challenges of implementation is overcoming resistance to change as no organization wants to be the first. For that reason, Summit faculty share change management strategies for people, processes, and technology that led to the effective implementation of their RBM programs. The Site’s perspective, assessing readiness for change and providing support during the change process must not be overlooked. Strategies to partner with Sites to achieve stronger connectivity will also be discussed.
This Risk Based Monitoring - Impact on Sites overview presentation, on targeted topics, was delivered to the ACRP Raleigh - Durham Chapter's Annual Conference in 2013.
The document discusses using gamification strategies to incentivize desired behaviors at clinical trial sites. It defines gamification as leveraging people's innate desire to compete and be recognized. The document outlines common behaviors to target, such as patient adherence and timeliness of data entry. It recommends using real-time reporting in an eClinical system to display metrics like leaderboards tracking performance. Finally, it provides some example gamification implementations, such as rewarding the clinical site with the highest patient compliance percentage or fastest data entry times.
Despite increased industry interest in risk-based monitoring (RBM) for clinical trials, most organizations have yet to develop standard operating procedures for its use. Those who have implemented RBM still face challenges related to resources, quality, and change management. As clinical research organizations play a central role in data monitoring, they are well-positioned to address barriers to RBM adoption and help standardize its application across stakeholders. Key factors for RBM success include early CRO involvement in trial planning, cross-functional collaboration, and use of advanced technology platforms to facilitate remote monitoring and risk assessment.
Pharma-CRO Relationships Managing Risk A Lawyer\'s Viewalbinpaul
The document discusses sponsor-CRO relationships and managing risks when outsourcing clinical trials to contract research organizations (CROs). It defines CROs and site management organizations (SMOs) and their roles. It also discusses selecting CROs, establishing metrics to measure performance, managing personnel changes and communications, and proactively avoiding and resolving disputes. The key aspects are selecting the right CRO based on expertise and compatibility, establishing metrics for accountability and continuous improvement, and clear communications and dispute resolution processes to facilitate the relationship.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
Risk based monitoring presentation into what Risk Based Monitoring (RBM) is all about. The value of getting it right, and the risks of getting it wrong. We look at the Triumph Research Intelligence (TRI) approach to RBM, and the TRI solution to RBM. An insight into the Future of Visual OPRA is given.
The Risk-Based Monitoring (RBM) discussion is moving away from one focused on changing monitoring methods and reducing source document verification (SDV) to 'intelligent monitoring.' Learn why here!
How are you doing your risk management in QMS? Or risk management in NPD (new product design) process? Here are simple 5 steps in this presentation.
More detailed information and templates are available at:
https://www.qualcy.com/blog/quality-risk-management-qms/
How much does it cost to launch and commercialize a companion diagnostic test?Diaceutics Group
We ask four senior executives to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. View the infographic to see what they came up with.
We defined low end as a follow on diagnostic product where a similar test exists in the market and a high end test which is a new biomarker (needing to establish novel clinical utility), or a new platform likely to be in oncology, a chronic disease like rheumatoid arthritis or a range of infectious markers requiring panel performance.
Source http://www.diaceutics.com/mystery-solved-what-cost-develop-and-launch-diagnostic#sthash.ryk5zoEa.dpuf
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
White Paper: From Here to Risk-Based MonitoringFreedom Monk
This white paper discusses risk-based monitoring approaches for clinical trials. It provides a framework for comparing different risk-based monitoring solutions, focusing on tailoring the approach for each individual study, looking backward to correct past errors, monitoring in real-time, ensuring future success through error prediction and prevention, and planning a successful transition. The paper emphasizes the importance of individualizing monitoring plans for each specific study based on risks, adjusting plans as needed during the study based on observed circumstances, and using metrics and indicators to proactively manage quality and performance in real-time rather than just focusing on detecting errors after the fact.
Dr. Ralf Kaiser discusses challenges and the future of risk-based monitoring in clinical trials. Some key challenges include getting approval from pharmaceutical companies and investigator sites for the new paradigm, training site personnel on new technical approaches, and ensuring compatible systems between CROs and sponsors. Over time, Dr. Kaiser envisions a transition to a common global database managed by regulatory authorities where most clinical trials are informed by big data rather than conducted de novo, with only confirmation studies involving limited subjects.
This document provides an overview of ICH Q9 Quality Risk Management. It defines key terms like quality, risk, risk management, and quality risk management. It describes the quality risk management process, which includes risk identification, analysis, evaluation, control, communication, and review. Various risk management tools are also discussed, as well as potential applications of quality risk management in industry and regulatory operations. Challenges of implementing quality risk management concepts are also acknowledged.
Integrating Trial Data Processes Across Functional Areas using Electronic Dat...www.datatrak.com
The document discusses how integrating an electronic data capture (EDC) system across functional areas like clinical monitoring, project management, investigator sites, and clinical data management (CDM) requires changes to processes, roles, and communication. It describes how data collection, recording, monitoring, and cleaning processes need to be re-engineered when transitioning from paper to an electronic system. Implementing an EDC system successfully requires redefining responsibilities and adjusting workflows between these groups to maximize benefits.
Use this template to create your Risk Based Monitoring guideline. Make sure you review this in conjunction with the Risk Based Monitoring in Practice presentation for the best possible result.
The survey found that risk sharing between sponsors and clinical service providers is common, with bonuses and penalties being the most prevalent models. Bonuses and penalties typically range from 2-10% of the contract value. While experiences with risk sharing have been mixed, most respondents found it primarily or generally positive.
Most sponsors and providers reported conducting systematic risk assessments for the majority of their clinical trials. Assessments focus on risks like patient enrollment, vendors, and data quality. They are usually qualitative but sometimes include quantitative elements. Providers are often involved in the assessments.
Assessments frequently lead to risk management measures like reviewing performance plans, capturing additional data, adjusting site numbers or locations, and adding
The document discusses the results of a 2014 survey on the use of data-driven approaches in clinical trials. It finds that while many respondents believe their use of such approaches has advanced in recent years, there is still significant room for improvement. Outsourcing relationships were seen as both promoting and potentially inhibiting their use, by increasing access to data and expertise but also sometimes creating challenges for change management and planning. Overall, the survey highlights opportunities to further apply analytical techniques to optimize clinical development processes and outcomes.
This document summarizes the results of a 2013 survey on managing risk in outsourced clinical trials partnerships. The survey explored different risk-sharing models sponsors and clinical service providers use, how risk is assessed, and whether risk-based management approaches have been successful. Most respondents reported using systematic risk assessments that evaluate risks like enrollment, vendors, data quality, and safety. While risk-based approaches have sometimes increased quality, responses on efficiency were mixed. Sponsors tend to be more satisfied with in-house teams for risk identification and communication compared to service providers like CROs. The document concludes that while executives reported strong understanding of risk management, operational teams could benefit from more training.
Sponsor and provider perceptions differ on satisfaction levels. Sponsors reported lower satisfaction than providers in several areas, including quality. This suggests providers may overestimate the quality of their services from sponsors' perspectives. Risk-sharing models are used more often in strategic relationships than transactional ones. Both sponsors and providers have had primarily positive experiences with guaranteed revenue streams in exchange for commitments. Penalties have drawn more negative responses. Bonuses and penalties tend to be low percentages, under 10%, of contract value.
This survey summarizes workers' compensation issues for approximately 600 respondents from various industries and company sizes. It finds that the top three most effective methods for controlling workers' compensation costs are instilling a safety-minded culture, having a light duty return to work policy, and providing an overall return to work policy. Additionally, over 75% of respondents have a written safety manual, with 85% reviewing them at least every two years. Respondents' greatest insurance concerns for 2016 are cost control, increasing exposures, and risk control.
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Renown Health (Reno, NV), now ranks among the best in the country for physician communication with patients, a key indicator of overall patient satisfaction. Learn how Suzanne Hendery and Dr. Rahul Mediwala and team used transparency, group inspection, adaptation and a change in data collection methods led to significant improvements in social media reviews, patient satisfaction and CG-CAPHS scores for Renown providers.
Partnerships in Clinical Trials Co-presentation with Alan Morgan The Avoca Group
This document discusses industry efforts to ensure effective oversight of outsourced clinical trials. It summarizes research conducted by the Avoca Quality Consortium on oversight practices. The research found that most sponsors and CROs are satisfied with the quality of work, though sponsors often hold CROs to higher standards than internal teams. It also identified challenges with oversight, including lack of role clarity, duplication of work, and inefficient use of resources. Recommendations include improving communication, transparency, planning and use of technology to enhance oversight.
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This document summarizes the results of a compensation communication practices survey conducted in February-March 2016 across Canadian companies. Key findings include: two-thirds of participants have a salary structure but communication practices vary; nearly 80% have short-term incentive plans but target bonuses are not always communicated; half calculate total compensation value but employees' understanding is limited; over 50% plan to increase communication efforts but most lack a formal plan. The survey highlights opportunities to improve transparency and better align practices with engagement and business goals.
Benchmarking Quality: How Medical Device and Diagnostics Companies Manage Cos...Best Practices
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Quality leaders can use the evidence-based metrics and insights for Quality spending, staffing, change request levels, outsourcing, software quality, inspections, lab testing, complaint management, trend insights and more.
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Adverse Event or Near Miss Analysis DetailsAt.docxcoubroughcosta
Adverse Event or Near Miss Analysis
Details
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Overview
Write a 5–7-page a comprehensive analysis on an adverse event or near miss from your professional nursing experience. Integrate research and data on the event and use as a basis to propose a quality improvement (QI) initiative in your current organization.
Health care organizations strive for a culture of safety. Yet despite technological advances, quality care initiatives, oversight, ongoing education and training, laws, legislation and regulations, medical errors continue to occur. Some are small and easily remedied with the patient unaware of the infraction. Others can be catastrophic and irreversible, altering the lives of patients and their caregivers and unleashing massive reforms and costly litigation.
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Context
The purpose of the report is to assess whether specific quality indicators point to improved patient safety, quality of care, cost and efficiency goals, and other desired metrics. Nurses and other health professionals with specializations and/or interest in the condition, disease, or the selected issue are your target audience.
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Questions to Consider
As you prepare to complete this assessment, you may want to think about other related issues to deepen your understanding or broaden your viewpoint. You are encouraged to consider the questions below and discuss them with a fellow learner, a work associate, an interested friend, or a member of your professional community. Note that these questions are for your own development and exploration and do not need to be completed or submitted as part of your assessment.
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Resources
Required Resources
MSN Program Journey
The following is a useful map that will guide you as you continue your MSN program. This map gives you an overview of all the steps required to prepare for your practicum and to complete your degree. It also outlines the support that will be available to you along the way.
MSN Program Journey
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Transcript
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Assessment Instructions
Preparation
Prepare a comprehensive analysis on an adverse event or near-miss from your professional nursing experience that you or a peer experienced. Integrate research and data on the event and use as a basis to propose a Quality Improvement (QI) initiative in your current organization.
Note
: Remember, you can submit all, or a portion of, your draft to Smarthinking for feedback, before you submit the final version of your analysis for this assessment. However, be mindful of the turnaround time for receiving feedback, if you plan on using this free service.
The numbered points below correspond to grading criteria in the scoring guide. The bullets below each grading criterion further delineate tasks to fulfill the assessment requirements. Be s.
Avoca Quality Consortium Associate Membership OverviewThe Avoca Group
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2014 Avoca Industry Report Executive Summary The Avoca Group
The document discusses a 2014 report from Avoca Group on the use of "intelligent" or data-driven approaches in clinical development. It found that both sponsors and providers apply these approaches most frequently to region and site selection. Providers reported greater advancement than sponsors in applying intelligent approaches across various clinical trial activities over the past two years. Sponsors viewed providers as making the most significant contributions to intelligent approaches for site selection, region selection, monitoring, and patient recruitment.
This document provides the agenda for the Fall 2014 Consortium Members' Meeting. The agenda includes:
- Case studies from member organizations on their experiences implementing Consortium best practices and tools
- Updates on 2014 initiatives and progress executing projects
- Interactive sessions for members to provide feedback on new quality agreement templates and prequalification standards for technical service providers
- Discussion of potential focus areas and initiatives for 2015, including leveraging the Consortium for knowledge sharing and transforming quality practices
The Avoca Quality Consortium Welcomes Takeda Pharmaceuticals The Avoca Group
Takeda Pharmaceuticals has joined The Avoca Quality Consortium, a collaborative of 36 member companies representing over half of the top pharmaceutical companies and CROs. The consortium aims to improve quality and efficiency in clinical trials through developing best practices, tools, and industry standards. Takeda's membership will help further the consortium's efforts to transform clinical trials and get new medicines to patients faster through collaboration.
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The Avoca Quality Consortium Summit 2014 Executive SummaryThe Avoca Group
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The document discusses challenges and solutions for implementing Quality by Design (QbD) when working with outsourced partners. It provides an overview of the Avoca Group and Avoca Quality Consortium, which help companies optimize quality management approaches. The document outlines a quality oversight framework and includes various tools and best practices for processes like quality management planning, supplier assessment, and change control when applying QbD principles with external partners.
The document provides an overview of the Avoca Quality Consortium, which was formed to develop best practices for proactive quality management of outsourced clinical trials. It discusses the state of the clinical trials industry that led to the Consortium's formation, including increased outsourcing and globalization. It then outlines the Consortium's approach, deliverables produced to date like Quality Agreements and metrics, and areas of ongoing focus such as guidelines for effective quality oversight and operationalizing proactive quality management. The overall goal is to improve quality and efficiency in clinical trials through collaboration and standardization.
The document provides an overview of Avoca's award decision programs. Avoca helps pharmaceutical companies and service providers understand what drives clients' award decisions through in-depth interviews. The interviews uncover perceptions of the bidding process and relationships. Avoca analyzes feedback on various aspects such as proposals, interactions, and defense meetings. They provide metrics comparing wins versus losses. The goal is to improve customer loyalty and profitability by helping clients understand what differentiates winning bids.
Training to Improve Relationships with Teams and Outsourced PartnersThe Avoca Group
The Avoca Group and Team Builders Plus have partnered to provide a customized team building program based on DISC behavioral styles. The program teaches participants to identify their own behavioral style as well as those of colleagues using metaphors of four birds: the Office Eagle, Office Parrot, Office Dove, and Office Owl. Attendees learn communication strategies to improve working relationships within teams and with partners. The interactive training enables teams to develop strong rapport and productivity. Feedback from clients finds the session engaging and useful for connecting training to individual needs.
The document describes Avoca's approach to conducting client feedback and customer satisfaction surveys for CROs. Avoca's surveys are designed to measure customer perceptions, identify strengths and weaknesses, gather information to improve satisfaction and retention, and inform strategic decisions. Avoca will collaborate with the CRO to design the survey, achieve a high response rate, provide real-time access to results, and offer recommendations based on the feedback.
Avoca 'Team Builder's Plus' training to improve relationships with teams and ...The Avoca Group
The Avoca Group and Team Builders Plus have partnered to provide a customized team building program based on DISC behavioral styles. The program teaches participants to identify their own behavioral style as well as those of colleagues using metaphors of four birds: the Office Eagle, Office Parrot, Office Dove, and Office Owl. Attendees learn communication strategies to improve working relationships within teams and with partners. The interactive training enables teams to develop strong rapport and productivity. Feedback from a client indicates that the engaging session helps participants understand themselves and connect with the material on an individual level.
Avoca Quality Consortium 2014 Summit Bio BookletThe Avoca Group
The document summarizes the 2014 Avoca Quality Consortium Summit, which brought together quality and operations professionals from pharmaceutical, biotechnology, and clinical research organizations. The goal was to accelerate the development of best practices for proactive quality management in clinical trials. Key topics included breaking down silos, advancing technology, and building bridges to patients. Guest speakers addressed transforming clinical trial execution to improve quality. The summit provided a forum for open discussion and new ideas to emerge.
Avoca Quality Consortium Meeting Topics Day 2, May 7The Avoca Group
The document outlines the agenda for the Avoca Quality Summit on May 7, 2014. The overall theme is "Progress through Collaboration – Breaking Down Silos, Advancing Technology, and Building Bridges to Patient". The agenda includes sessions on quality by design, the clinical research sites' perspective, a keynote on patient-centered research, crowdsourcing solutions, and clinical trial optimization. Speakers will discuss incorporating quality principles into outsourced programs, effective site engagement, an investigator databank, treating patients as equal partners, and applying "out of industry" technology approaches.
Avoca Quality Consortium Meeting Topics, Day 1 May 6 The Avoca Group
The document provides an agenda for the Avoca Quality Summit on May 6, 2014. The overall theme is "Progress through Collaboration – Breaking Down Silos, Advancing Technology, and Building Bridges to Patients". The agenda includes sessions on reducing risk and improving quality in clinical trials through prequalification of third parties, presenting results from a member assessment survey, breakout groups to discuss quality guidelines and tools, enhancing quality metrics and benchmarking, and a discussion on using big data to inform clinical trial execution.
The document discusses services provided by The Avoca Group to help companies build, measure, manage, and improve critical business relationships, particularly strategic partnerships between biopharmaceutical sponsors and clinical research organizations (CROs). Avoca has extensive experience consulting on strategic partnerships in clinical outsourcing. They developed the Art and Science of Partnering framework to help manage these relationships. Services include partnership assessments through surveys, consulting on implementation and change management, and training on best practices for strategic partnerships.
Avoca Group was founded in 1999 and has since established several programs and initiatives focused on improving relationships and quality in clinical outsourcing. Some key events include Avoca launching the first comprehensive Relationship Management Program for a CRO in 2004, developing a system for measuring key relationship indicators in 2000, and CEO Patricia Leuchten being named one of the most inspiring individuals in the life sciences industry in 2012.
PATRICIA LEUCHTEN WINS BRONZE STEVIE® AWARD IN 2013 STEVIE AWARDS FOR WOMEN I...The Avoca Group
Patricia Leuchten, founder and CEO of pharmaceutical consulting and survey research firm The Avoca Group, has been named the winner of a Bronze Stevie® Award in the ‘Maverick of the Year’ category. Leuchten accepted the award at the 10th annual Stevie Awards for Women in Business held in New York City.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
1. The State of Clinical Outsourcing
Managing Risk in Outsourced Clinical Trials
Interactive Discussion Based on Data from
Avoca’s 2013 Industry Research
DIA Forum
June 24, 2013
2. 2
Panel Members
Denise Calaprice-Whitty (Forum Chair)
Senior Consultant, The Avoca Group
Andy Lee
Senior VP, Deputy Head of CSO Platform,
Genzyme, a Sanofi Company
Mitchell Katz
Executive Director, Medical Research Operations,
Purdue Pharma L.P.
Alistair Macdonald
Chief Operating Officer, INC Research
3. 3
Today’s Discussion
Presentation of Data Highlights from Avoca 2013 Industry
Survey, and Interactive Discussion
Avoca 2013 Industry Survey Topic:
Management of Risk in Outsourced Clinical Trials
• Part One: Risk Sharing Models
• Part Two: Risk Assessment
• Part Three: Risk Management
4. 4
2013 Avoca Research: Questions Explored
• Risk-sharing models: What kinds of models are most often used? Under
what circumstances? What are the magnitudes of the incentives/
penalties? Have they been successful? In what ways? What have been
the downsides?
• Risk assessments: How often are these conducted, and by whom? Are
they just qualitative, or also quantitative? On what types of risks do they
focus? Do stakeholders generally agree about risks? Have these
approaches been successful? In what ways?
• Risk-based management approaches: To what tasks have such
approaches been applied? Have they been successful? In what ways?
What have been the downsides? How has this work been viewed by
regulators?
5. 5
2013 Avoca Research Respondents
237 Respondents
• Sponsors: 113 Respondents from 70 companies
– Approximately half in top 20 in terms of revenue
• 66% Pharma
• 26% Biotech
• 5% Device
• 3% Combination/Other
• Clinical Service Providers: 124 Respondents from 66 companies
– 60% in top 20 in terms of revenue
• 86% CROs
• 11% Niche
• 3% Laboratories
7. 7
Types of Risk-sharing Between
Sponsors and Providers
• Provider bonuses for achieving milestones or targets
• Provider penalties for missing milestones or targets
• Guarantees of continued work/revenue stream in exchange
for provider commitments
• Provider stake in outcome of study (e.g., company stock)
8. 8
Prevalence of Risk Sharing: Sponsors
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Strategicpartnerships/
alliances(N=28)
Preferredprovider
relationships(N=43)
Trasactional
relationships(N=37)
Bonuses Penalties Guarantees of continued work/revenue Provider stake in outcome
For each of the types of outsourcing relationships listed, which of the risk-sharing
models listed has your company used?
9. 9
N=33
Magnitude of Bonuses and Penalties
3%3%
27%
61%
6% >20% of
contract value
11-20% of
contract value
6-10% of
contract value
2-5% of
contract value
<2% of
contract value
Sponsor Data:
When bonuses are used, what is
generally the magnitude of the
maximum possible bonus?
3%3%
26%
61%
7% >20% of
contract value
11-20% of
contract value
6-10% of
contract value
2-5% of
contract value
<2% of
contract value
Sponsor Data:
When penalties are used, what is
generally the magnitude of the
maximum possible penalty?
N=31
10. 10
Experience with Risk-sharing by Sponsors
54%
35%
14%
41%
56%
41%
6%
9%
45%
0% 20% 40% 60% 80% 100%
Guarantee of continued work/revenue stream
in exchange for provider commitments
Provider bonuses for achievement of
milestones/targets
Provider penalties for failure to achieve
milestones/targets
Primarily positive A mix of positive and negative Primarily negative
N
54
57
58
To date, my experience with each of the below risk-sharing outsourcing models
has been…
11. 11
Experience with Risk-sharing by CROs
58%
46%
24%
40%
48%
47%
2%
7%
29%
0% 20% 40% 60% 80% 100%
Guarantee of continued work/revenue stream
in exchange for provider commitments
Provider bonuses for achievement of
milestones/targets
Provider penalties for failure to achieve
milestones/targets
Primarily positive A mix of positive and negative Primarily negative
N
61
51
53
To date, my experience with each of the below risk-sharing outsourcing models
has been…
12. 12
Sponsor Data: All Respondents
Overall, how satisfied are you with the work that has been done for you by Clinical
Service Providers (including but not limited to CROs)?
5%
50%
60%
71%
100%
50%
30%
24%
10%
0% 20% 40% 60% 80% 100%
>10% of contract value
6-10% of contract value
2-5% of contract value
<2% of contract value
Very satisfied Generally satisfied
Neither satisfied nor dissatisfied Generally dissatisfied
Very dissatisfied
N
2
10
21
2
Magnitude of the maximum
possible penalty
13. 13
Comments on Experiences
• “These relationships require absolute clarity in roles and
responsibilities and up-front planning assumptions that we
have not always had, which has caused difficulties along
the way.”
• “The inclusion of provider bonuses and penalties has had a
detrimental affect on study team morale. OK when the
target has been reached outright, but
lots of 'extra' negotiating when a
negative outcome.”
14. 14
Comments on Experiences
• “In my opinion a CRO doesn't perform better only because
they have a bonus or a penalty. The bonus is a way to show
them appreciation at the end but never a motivational
factor. Aligning with the CRO at the beginning on
deliverables and sharing risks and pitfalls before signing the
contract will increase the trust level and consequently the
commitment.”
15. 15
Comments on Experiences
• “CRO must have complete decision-making authority on the
operational aspects of trial execution (minimal handoffs/
decisions by sponsor). CRO must be compensated for a
thorough feasibility assessment and allowed to select the
suppliers they believe will deliver (without sponsor imposing
non-producing investigators in the mix). Also, sponsor
company must be willing to provide both the penalty as well
as the reward. In my experience, penalties were never
applied because there were always mitigating factors
(sponsor impacted operational success due to slow
response or non-response to needs or due to sponsor
mandate of key requirements- such as SOPs, KOLs, etc.).”
17. 17
39%
19%
26%
13%
3%
N=31
Prevalence of Systematic, Formal Risk
Assessments in Outsourced Trials
38%
18%
16%
14%
14%
For >75% of
outsourced
clinical trials
For 51% - 75% of
outsourced
clinical trials
For 25% - 50% of
outsourced
clinical trials
For 1% - 24% of
outsourced
clinical trials
Never
N=50
Sponsors CROs
Most sponsors and clinical service providers reported that a
systematic risk assessment process was used for the majority of
their clinical trials.
18. 18
Sponsor Use of Systematic Risk Assessment Processes:
Is there a difference based on size of company?
50%
32%
13%
21%
19%
15%
13%
15%
6%
18%
0% 20% 40% 60% 80% 100%
Yes
No
For >75% of clinical trials For 51% - 75% of clinical trials For 25% - 50% of clinical trials
For 1% - 24% of clinical trials Never
N
16
34
Top 20?
19. 19
N=63
CRO Involvement in Systematic Risk Assessment
32%
47%
16%
5%
Sponsor Data:
For outsourced clinical trials, to what
extent is the CRO generally involved in
the systematic risk assessment?
Provider Data:
To what extent is your company
generally involved in the systematic risk
assessment?
48%
39%
5%
8%
N=66
20. 20
What Risks are Assessed?
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Patientenrollmentrisks
Vendorperformance
risks
Dataqualityrisks
Othertimelinerisks
Sitecompliancerisks
Costrisks
Clinicaltrialsubject
safetyrisks
Drug/devicesupply-
relatedrisks
Riskstorightsof
clinicaltrialsubjects/
ethics
Other
Sponsor (N=70) Provider (N=75)
When a systematic risk assessment is performed for projects conducted by your
company, which of the following risks are typically formally assessed?
21. 21
N=68
Risk Assessment:
Qualitative or Quantitative?
43%
9%
41%
7% Primarily
qualitative
Primarily
quantitative
Approximately
equal mix
across trials
It depends
Is the risk assessment process primarily qualitative (e.g. risks identified and
discussed), or quantitative (e.g. probabilities and consequences of specific risks
estimated quantitatively)?
32%
15%
53%
Primarily
qualitative
Primarily
quantitative
Approximately
equal mix
across trials
N=66
Sponsors CROs
23. 23
How often does your risk assessment
process lead to the introduction or
refinement of proactive measures designed
to reduce risk?
24. 24
Reducing Risk: Sponsor Data
51%
50%
34%
34%
31%
29%
29%
28%
28%
24%
12%
15%
31%
28%
19%
20%
31%
21%
12%
22%
26%
25%
27%
34%
40%
39%
36%
32%
47%
41%
12%
10%
8%
4%
10%
11%
4%
19%
12%
13%
0% 20% 40% 60% 80% 100%
Review plan for performance data
Capture of performance data (i.e. not clinical trial data)
Changes in numbers of sites selected
Training additions/enhancements
Personnel additions/enhancements
Protocol amendments
Procedural additions/enhancements
Changes in locations of sites selected
Decisions regarding CROs/other vendors used
Addition or removal of specific sites
For >50% of clinical trials For 25% - 50% of clinical trials For 1%-24% of clinical trials Never
N
43
48
49
50
42
44
45
47
49
46
How often does your risk assessment process lead to the introduction or
refinement of each of the following proactive measures designed to reduce risk?
25. 25
Reducing Risk: Provider Data
How often does your risk assessment process lead to the introduction or
refinement of each of the following proactive measures designed to reduce risk?
47%
45%
38%
34%
31%
23%
21%
18%
16%
14%
22%
19%
32%
36%
35%
33%
27%
33%
19%
13%
26%
30%
30%
23%
33%
35%
48%
43%
56%
50%
4%
6%
7%
2%
9%
5%
8%
9%
24%
0% 20% 40% 60% 80% 100%
Review plan for performance data
Capture of performance data (i.e. not clinical trial data)
Procedural additions/enhancements
Changes in numbers of sites selected
Training additions/enhancements
Changes in locations of sites selected
Addition or removal of specific sites
Personnel additions/enhancements
Protocol amendments
Decisions regarding CROs/other vendors used
For >50% of clinical trials For 25% - 50% of clinical trials For 1%-24% of clinical trials Never
N
46
47
44
44
46
43
44
40
43
38
26. 26
N=50
Use of Risk-related Information to Determine
Oversight of CROs
24%
22%
20%
14%
20%
For >75% of
clinical trials
For 51% - 75% of
clinical trials
For 25% - 50% of
clinical trials
For 1% - 24% of
clinical trials
Never
Sponsor Data
27. 27
Satisfaction with CROs
9% 73%
56%
9%
41%
9%
4%
0% 20% 40% 60% 80% 100%
For >50%
For <50%
Very satisfied Generally satisfied
Neither satisfied nor dissatisfied Generally dissatisfied
Very dissatisfied
How often do your
teams use risk-related
information to
determine the level
and/or type of sponsor
oversight that you will
employ for your CRO
partners?
N
23
27
by Use of Risk-related Information
to Determine Oversight
28. 28
Satisfaction with Risk Assessment and
Management Performance
Scale of 1 to 5; 1=Very dissatisfied, 5=Very satisfied
29. 29
Opportunities to Enhance Understanding
38%
13%
9%
23%
54%
36%
31%
23%
45%
8%
10%
9%
0% 20% 40% 60% 80% 100%
Executive
Management
Middle
Management
Project
Management
Very strong understanding Good understanding
Fair understanding Poor understanding
N
13
39
11
How would you rate your understanding of best practices in risk assessment
and management in clinical trials? (Sponsor Data)
While executives generally reported a strong understanding,
operational teams may benefit from more training.
30. 30
Are risk-based approaches leading to greater
efficiency and higher quality?
14%
32%
38%
34%
23%
6%
25%
28%
0% 20% 40% 60% 80% 100%
more efficient use of resources
for your company and/or
your CRO partner?
increased quality?
Yes Sometimes No Don't know/too soon to tell
N
65
65
In general, have your risk assessment and management approaches resulted in…
32. 32
Definitions Included in Avoca Survey
Risk is defined as "the combination of the probability of occurrence of harm and the
severity of that harm" (ISO/IEC Guide 51).
RISK ASSESSMENT AND MANAGEMENT (taken from FDA Guidance for Industry Q9:
Quality Risk Management).
Risk assessment: A systematic process of organizing information to support a risk
decision to be made within a risk management process. It consists of the identification of
hazards and the analysis and evaluation of risks associated with exposure to those
hazards.
Risk management: The systematic application of quality management policies,
procedures, and practices to the tasks of assessing, controlling, communicating, and
reviewing risk.