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.
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
Effective risk management needs effective risk identification, assessment, planning, tracking and controlling in Clinical Trials. Considering the importance of risk management in efficient management of clinical trials, this webinar by DDismart will provide more insight on Clinical RBM.
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.
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
Effective risk management needs effective risk identification, assessment, planning, tracking and controlling in Clinical Trials. Considering the importance of risk management in efficient management of clinical trials, this webinar by DDismart will provide more insight on Clinical RBM.
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.
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 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.
Niki Kutac, Director Product Management, delivered this presentation at the ACRP 2014 Conference where it was rated the #1 Session of the Event. Learn how to implement gamification to produce the desired end result.
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.
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
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.
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.
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 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.
Niki Kutac, Director Product Management, delivered this presentation at the ACRP 2014 Conference where it was rated the #1 Session of the Event. Learn how to implement gamification to produce the desired end result.
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.
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
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.
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.
Top 5 tips for managing risks in your clinical studies - PepgraPEPGRA Healthcare
Fronting ever-increasing costs of running a clinical trial, sponsors must guarantee they are correctly directing their financial plan and resolving the highest risk areas while preserving patient safety and data reliability in Patient recruitment for clinical trials. In this blog, Pepgra provides five tips for significant risk levels in clinical studies like:
1. Outlining your levels of risks
2. Evaluating and categorizing risk
3. Concentrating on essential areas of risk
4. Observing and controlling risks
5. Estimating the efficiency of risk management
Read More: http://bit.ly/3bb4j6h
Youtube: https://youtu.be/EGH6WDsqSSw
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
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.
useful for pharmaceutical quality assurance students, MBA and all people including industry employee to improve knowledge about the quality risk management process
TRI was founded as a subsidiary of Triumph Consultancy Services in 2013, following 12 years of consulting to the clinical trial industry. TRI has been evaluating the specific challenges facing the industry when implementing a risk-based monitoring strategy and the various approaches and products being utilized by organizations as they move into the RBM arena. This paper aims to summarize our findings and provide guidance as to how the main challenges can be overcome.
18
MPM344 Project Risk Management
Medical Needs Risk Management
Connie Farris
11/21/2018
Table of Contents
Project Outline 3
Project Description 3
Method (Agile or Waterfall) 3
Risk Categories 4
Risk Register 6
Project Risk Analyses 9
Qualitative Risk Analysis 9
Project Risk Response Strategy TB 11
Risk Response Strategy 11
Plan for Reviewing Risk Responses 12
Identification of New Risks 14
Project Risk Communications Plan TB 15
Communications Matrix 15
Memo to the Project Sponsor 16
References 17
Project OutlineProject Description
The quality gauges of therapeutic devices contain numerous viewpoints, for example, plan control, Risk management, vendor management etc. (Singh, 2017) In this paper we are going to discuss the importance of Risk management for medical devices and steps to perform during the product development stage. Risk management is a critical part of the medical device product development lifecycle. (Singh, 2017) It enables medical device engineers to guarantee that the item is dependable, functions obviously and will be no damage to the patients, administrators or the earth. In other words, the main purpose of the Risk management cycle is to lessen or curb the odds of disappointment in the item.
Medical Needs is a company that designs and manufactures medical devices and will be opening a new company and would like for us to do the risk management involved with the materials used for these devices and the design to ensure the devices are compliant to all regulations during production. There are many areas we will cover during this project to ensure that a quality product is available for the public consumer. We are looking at completing this project in less than six months before the manufacturing process commences. We will look at everything from vendor, mechanical and that everything planned before the company is open will be as risk free as possible.
Method (Agile or Waterfall)
. We will be using an Agile Method to conduct this risk assessment. The agile methodology with more checkpoints, gives you a chance to refine what you are working for the client, and what they are at last given. (Tan, 2016) Agile gives the chance to take what you made, offer it to a customer, and bring out criticism. Considering the input, you can decide if you are going the correct way. (Tan, 2016) If changes are required, you give yourself the chance to adjust and alter. When creating medicinal devices, numerous sources of info that must be contemplated. Distinguish the requirements of the end client however comprehend the potential dangers that the item may present to end clients and guarantee that your item is adequately protected and powerful by structuring risk adjustment into your medical device.
When using the agile process, you must understand how the Risk management process fits in, and then consolidate that approach into the project development plan. (Tan, 2016) By using t.
Delays in the launch and execution of critical market research projects can slow down the decision-making process, resulting in missed opportunities and increased costs. Therefore, it is absolutely critical for bio-pharmaceutical companies to develop a tactical approach to expedite the market research approval process for quicker and more meaningful insights.
According to recent research by Best Practices, LLC, nearly three-quarters of the benchmarked study participants use review cycle time as a metric for determining if the market research approval process is functioning at an acceptable level. One tip that participants gave on how to control processes and to ensure high performance is to create checklists. Begin with checklists in pinch points that are most problematic, and then extend to entire process and operations. This report will help leaders to gain critical insights they need to compete successfully in a fast-changing market.
Download Full Report: http://bit.ly/2bfAhOc
Current Trends in Data Protection for Integrated Health, Centralized Peer Rev...PYA, P.C.
A webinar hosted by PYA and the Alliance for Quality Improvement (AQIPS) explored “Current Trends in Data Protection for Integrated Health, Centralized Peer Review Systems, and Other Innovative Programs.” PYA Principal Martie Ross participated in the webinar, which focused on how patient safety organization (PSO) protections can bring value to accountable care organizations and other integrated health systems.
In addition, the webinar provided instruction for using:
Patient Safety and Quality Improvement Act (PSQIA) protections in Medicare Shared Savings Programs, centralized peer review programs, and other collaboratives.
PSQIA protections for new types of clinical analysis, clinical quality reports, and performance tools that contain information that may not be protected under existing state peer review privilege or are shared among an integrated network.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Vendor Management - Compliance Checklist Manifesto SeriesContinuity Control
Regulatory examiners are expecting to see and review your financial institution's vendor management program, which is to include a process for assessing specific vendor risk, vendor selection, contracting, and ongoing oversight. This webinar will demonstrate that implementing a repeatable process will provide consistency and reduce your institution's Compliance Tax by saving you time and resources, including helping to ensure your valuable dollars are spent wisely.
Objectives:
- Understanding of the regulatory requirements for the vendor management program
- High level overview of the key elements
- Provide guidance in developing your program
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.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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.
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
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
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
1. Sponsor and Provider
Perceptions on Managing
Clinical Development Risk
ICR
Event
Enhancing
the
risk
based
approach
to
clinical
trials
2. 2
The Avoca Group
The Avoca Group helps pharmaceutical and biotech companies and
service providers build, measure, and manage critical business
relationships.
Why Avoca?
● Avoca works exclusively in the pharmaceutical industry, focusing on clinical
outsourcing, strategic alliances and alliance/relationship management.
● Avoca has a deep understanding of sponsor preferences, leading practices
and the health of relationships gained through nearly 15 years of collecting
and analyzing quantitative and qualitative data on behalf of both sponsors
and CROs.
● Avoca’s Senior Consultants possess both process improvement and change
management expertise as well as significant industry experience.
● Avoca has unique perspectives of competing organizations’ practices and
approaches for alliance management. We understand areas that competitors
struggle with and can provide guidance to support effective differentiation.
3. 3
2013 Avoca Research Overview
Introduction
● Each year The Avoca Group surveys industry executives and managers to
understand trends in clinical development, with a particular focus on
outsourcing dynamics and relationships between research sponsors and
providers.
● Over the past several years we have participated in numerous conversations
with biopharmaceutical companies and providers on the topic of risk
reduction in the clinical development process.
● According to various sources and published metrics, the industry remains
challenged by relatively low success rates for compounds in clinical
development, and this has prompted many organizations to explore ways
of reducing the risk associated with the clinical development process.
● With this in mind, Avoca chose to perform a comprehensive assessment of
the methods used to evaluate and manage risk in outsourced clinical trials
for our 2013 Industry Survey, with a focus on risk sharing models, risk
assessment, risk management and risk-based monitoring.
● This report serves as an Executive Summary of key findings from the research.
4. 4
2013 Avoca Research Overview
Questions Explored
● Risk-sharing models: What types of models are used most often? Under
what circumstances? What is the magnitude of incentives/penalties? Have
the incentives/penalties been successful? Is success realized predominantly
by improvements in time, cost, or quality? What have been the downsides?
● Risk assessment: Is it formally done? How is it done? To what extent are
assessments qualitative vs. quantitative? Have they been successful? In
what ways have they worked and in what ways have they not?
● Risk-based management approaches: To which tasks have such
approaches been applied (e.g. monitoring, CRO management)? Have the
approaches used formal quantitative modeling, or have they been
qualitative? Have they been successful? Is success realized predominantly
by improvements in time, cost, or quality? What have been the downsides?
Are there any issues related to regulatory acceptance?
5. 5
Systematic Risk Assessment Contributors
Involvement in Conducting
Systematic Risk Assessment
Both Sponsor and Provider respondents often reported that risk assessment was performed
jointly; however, those who felt that it was performed primarily by one party were much more
likely to report their company was primarily conducting the assessment than the other party.
A variety of functional groups were reported to be involved in the process.
A joint CRO/Sponsor process
Performed primarily by my company
Conducted primarily by the other party
It depends
Functional Groups Involved in
Risk Assessment
Risk assessment is generally: 0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Project/Program Management
Operational team members
Functional Management
Quality Assurance
Outsourcing/Procurement
Senior/Executive Management
Business Development/Alliance Management
Legal/Finance
Sponsor (N=69) Provider (N=79)
32%
48%
47%
39%
16% 5%
5% 8%
Sponsors Providers
N=63 N=66
Q (Sponsor): For outsourced clinical trials, to what extent is the CRO generally involved in the systematic risk
assessment? Q (CRO): To what extent is your company generally involved in the systematic risk assessment?
Q; What functional groups and roles are generally involved in the risk assessment process?
6. 6
Systematic Risk Assessment Components
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Patient enrollment risks
Vendor performance risks
Data quality risks
Other timeline risks
Site compliance risks
Cost risks
Clinical trial subject safety risks
Drug/device supply-related risks
Risks to rights of clinical trial subjects/ethics
Sponsor (N=70) Provider (N=75)
Multiple risks are typically included in systematic assessments, with patient enrollment as
the one most frequently cited by respondents. Regarding the features of each risk that
are assessed, both groups reported evaluating risk probability, severity, ability to
proactively reduce risk and ability to remediate risks as common elements.
Types of Risks Assessed During Formal Reviews
Q: When a systematic risk assessment is performed for projects conducted by your company, which of the following risks are typically formally assessed?
Q: When a systematic risk assessment is performed, what features of each risk are generally assessed?
7. 7
Systematic Risk Assessment Results
In general, have your risk assessment and management approaches resulted in…
14%
23%
32%
45%
38%
56%
34%
39%
23%
3%
6%
25%
18%
28%
15%
N=65
Yes Sometimes No Don’t Know / Too
Soon to Tell
Risk management approaches appear to be yielding some benefits,
particularly with respect to increased quality, but most respondents were not
willing to provide a definitive “yes” to the questions, particularly those from
Sponsor organizations.
More efficient use of resources for your company and/or sponsor partner?
Increased quality?
Sponsors
Providers
Sponsors
Providers
N=66
N=65
N=66
8. 8
Risk-Based Monitoring Frequency
17% 13% 14% 18% 18%
30%
13%
36%
8%
21%
17%
13%
5%
15%
26%
19%
27%
26%
29%
9%
42%
23%
44%
18%
Top 20 Non Top 20 Top 20 Non Top 20 CROs
Usage Frequency of Risk Based Monitoring of Investigative Sites
As a group, Sponsor respondents from Top 20 firms were more likely to report frequent
use of risk-based monitoring of investigative sites than were those from Non-Top 20 firms,
for both in-house and outsourced trials. The distribution of frequency of RBM use
among CROs seems to be intermediate between the two sponsor groups.
N
51-75% of trials
>75% of trials
25-50% of trials
1-24% of trials
Never
SPONSORS CROs
In-House Trials Outsourced Trials
23 31 22 39 34
Q: How often does your company use a risk-based approach to the monitoring of Investigative Sites for clinical trials managed and conducted by in-house
teams? Q:How often do your project/program teams (including the CRO partners) use a risk-based approach to the monitoring of Investigative Sites for
outsourced clinical trials? Q (CROs):How often does your company use a risk-based approach to the monitoring of Investigative Sites?
9. 9
Risk-Based Monitoring by Phase
15%
37%
60%
50%
38%22%
43%
72% 70%
78%
Phase I Phase II Phase III Phase IIIb Phase IV
Sponsors Providers
Use of Risk-Based Monitoring by Clinical Study Phase
% of Respondents that Have Used RBM
A greater proportion of Provider respondents reported having used risk-based
monitoring of sites for each phases of clinical development compared to Sponsor
respondents. The difference is particularly pronounced in later phases of development.
Sponsor N 39 46 48 46 37
Provider N 37 42 46 43 41
Q: For what phases of clinical studies have you used, or would you consider using, a risk-based approach to investigative site monitoring? (only “have used”
shown)
10. 10
Risk-Based Monitoring Implications
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Frequency of site visits
Data elements for which Source Data Verification is performed
Centralized monitoring of data
Duration of site visits
Visits to site by staff other than the CRA
Seniority of CRA assigned to monitor site
Sponsor (N=58) Provider (N=45)
Across the samples, various adjustments were reported when using risk-based
approaches to monitoring sites. The frequency of site visits and aggressiveness of data
monitoring of data were adjusted by the greatest percentages of respondents.
Trial Elements Adjusted According to Risk-Based Monitoring Approach
Q: When you use a risk-based approach to monitoring, which of the following do you adjust depending on the level of assessed risk?
11. 11
Conclusions and Takeaways
● There appears to be a disconnect between Sponsors and Providers
regarding perceptions of the overall quality of service that is being
delivered, as 87% of Provider respondents reported being “very satisfied” or
“generally satisfied” vs. 53% of Sponsor respondents.
● As a group, Sponsor respondents from Top 20 firms were more likely to report
frequent use of systematic risk assessment processes for clinical trials than
were those from Non-Top 20 firms, for both in-house and outsourced trials.
● A majority of respondents from both Sponsor and Provider organizations
reported that their companies had used at least one type of risk-sharing
model. Respondents from both groups were much more likely to report
having had positive experiences using guaranteed revenue streams in
exchange for provider commitments than using penalties for failing to
achieve milestones/targets.
● Based on respondents’ answers to open-ended questions, investing time to
ensure that both Sponsors and Providers have a clear understanding of
expectations at the beginning of a risk-sharing relationship and establishing/
implementing effective Communication Plans appear to be critical
elements of success in risk sharing.
12. 12
Conclusions and Takeaways
● While respondents from Top 20 firms were more likely to report frequent use
of systematic risk assessment processes by their companies, respondents
from Non-Top 20 firms were more likely to report frequent utilization of the
information to drive the level of CRO oversight.
● Multiple risks are typically included in systematic assessments, with patient
enrollment as the most frequently cited by respondents. Regarding the
features of each risk that are assessed, both Sponsors and Providers reported
evaluating risk probability, severity, ability to proactively reduce risk and
ability to remediate risks as common elements
● The vast majority of respondents reported at least sometimes changing
aspects of clinical trial design, execution, or management based upon
information gathered from risk assessments, but most of the possible
changes addressed by the survey were made by most respondents for only
a minority of clinical trials.
● Sponsor respondents expressed higher levels of satisfaction with their in-
house teams than with their CROs and other service providers on every risk
assessment attribute evaluated. CRO respondents provided higher ratings of
their own performance than Sponsors did, suggesting a perception gap with
respect to CRO performance.
13. 13
Conclusions and Takeaways
● Risk management approaches appear to be yielding some benefits,
particularly with respect to quality, as one-third of Sponsor respondents
confirmed that quality had increased and another one-third reported that
quality had increased some of the time.
● As a group, Sponsor respondents from Top 20 firms were more likely to report
frequent use of risk-based monitoring of investigative sites than were those
from Non-Top 20 firms, for both in-house and outsourced trials. The
distribution of frequency of RBM use among CROs seems to be intermediate
between the two sponsor groups.
● Across the samples, various adjustments were reported when using risk-
based approaches to monitoring sites. The frequency of site visits and
aggressiveness of data monitoring of data were adjusted by the greatest
percentages of respondents.
● Satisfaction among Sponsor respondents with their CRO partners’ RBM
expertise and ability to deliver quality studies using an RBM approach was
below the satisfaction ratings CRO respondents awarded their own
companies. This is consistent with other findings on overall quality and the
ability to successfully perform risk assessments, suggesting that some CRO
respondents may overestimate the extent to which they are meeting
Sponsors’ needs.
14. Thank you
Contact Avoca at:
(609) 252-9020
www.theavocagroup.com
info@theavocagroup.com
179 Nassau Street
Suite 3A
Princeton, NJ 08542