Evolving your FSP relationships to achieve maximum returnMMS Holdings Inc.
To watch this webinar, please visit: https://bit.ly/3bUL4yO
The drug development lifecycle can be predictably unpredictable, as mergers and acquisitions, interim results, DSMB decisions, reorganization, and evolving technology can all change the course of any plan in short order. Sponsors rely on the ability of Clinical Research Organization (CRO) partners to provide scalability and global reach in support of their core teams. FSP relationships however, can go beyond the ability to quickly ramp up and down. Explore with us, as we discuss how Sponsors who leverage FSP partners across multiple interdependent functional lines achieve the maximum benefit and the increasing importance of the way that new innovations and technology continue to change the way we work and the future skill sets needed.
In this Expert Insights webinar, attendees will learn:
• How to achieve maximum benefit from FSP relationships
• The need for diversification in the vendor portfolio
• The potential for nimble adaptation and growth in long-term FSP partnerships
• Possibilities for investing and growing together with your FSP partner
• Implications and potential solutions for IR35 compliance
How to Use Machine Learning in Clinical Research Right NowMMS Holdings Inc.
To watch this webinar, please visit: https://bit.ly/3yUm5pw
In machine learning, there are usually one of two distinct objectives: inference or prediction. In analyses involving clinical trial data and/or real-world data, a machine learning solution can be used by data scientists to detect patterns that conventional analysis and statistical methods cannot. Thus, a machine learning practitioner can help to infer which subgroups that respond, either particularly well or poorly, to a treatment. Similarly, machine learning algorithms can be used to predict a discrete or time-to-event outcome. When knowledge increases of subgroups of interest and on outcomes before they occur, the impact on patient care and clinical research is very powerful.
In this Expert Insights webinar, attendees will learn:
• Why data science and the use of machine learning is essential to pharmaceutical, biotech, and medical device organizations
• How to use machine learning to understand outcomes before they occur
• Practical approaches for inference or prediction through machine learning
• Metrics to evaluate the performance of predictions made
Possibilities for the future of machine learning in clinical research
Partnership between CROs and Drug companiesKevin Lee
There is a new trend in the working relationships between CROs and Drug companies. The relationships evolve from the traditional transactional model to a partnership in the recent years. The partnership in the pharmaceutical industry is a new adventure to both CROs and Drug companies, and it also impacts programmers.
The partnerships will bring the new challenges and opportunities to programmers. We will work with not only our colleagues, but also employees from other vendors and clients. The partnership working environments will require the new set of rules and behaviors. The paper will discuss what kind of challenges and opportunities we will encounter and how we will resolve and succeed in the partnership working environments. The paper will specifically discuss the role of a project leader in CRO who are working directly with the clients and other vendors in the partnership environments. It will emphasize how important the culture is in the partnership environments and how the project leader helps to build the right cultures in the partnership environments.
Innovative Procurement Strategies for Thriving in a Networked EconomySAP Ariba
Building an agile procurement organization requires a focus on value, performance and capabilities.
Presented by Amy Fong – Senior Director, Procurement Executive Advisory - The Hackett Group
Evolving your FSP relationships to achieve maximum returnMMS Holdings Inc.
To watch this webinar, please visit: https://bit.ly/3bUL4yO
The drug development lifecycle can be predictably unpredictable, as mergers and acquisitions, interim results, DSMB decisions, reorganization, and evolving technology can all change the course of any plan in short order. Sponsors rely on the ability of Clinical Research Organization (CRO) partners to provide scalability and global reach in support of their core teams. FSP relationships however, can go beyond the ability to quickly ramp up and down. Explore with us, as we discuss how Sponsors who leverage FSP partners across multiple interdependent functional lines achieve the maximum benefit and the increasing importance of the way that new innovations and technology continue to change the way we work and the future skill sets needed.
In this Expert Insights webinar, attendees will learn:
• How to achieve maximum benefit from FSP relationships
• The need for diversification in the vendor portfolio
• The potential for nimble adaptation and growth in long-term FSP partnerships
• Possibilities for investing and growing together with your FSP partner
• Implications and potential solutions for IR35 compliance
How to Use Machine Learning in Clinical Research Right NowMMS Holdings Inc.
To watch this webinar, please visit: https://bit.ly/3yUm5pw
In machine learning, there are usually one of two distinct objectives: inference or prediction. In analyses involving clinical trial data and/or real-world data, a machine learning solution can be used by data scientists to detect patterns that conventional analysis and statistical methods cannot. Thus, a machine learning practitioner can help to infer which subgroups that respond, either particularly well or poorly, to a treatment. Similarly, machine learning algorithms can be used to predict a discrete or time-to-event outcome. When knowledge increases of subgroups of interest and on outcomes before they occur, the impact on patient care and clinical research is very powerful.
In this Expert Insights webinar, attendees will learn:
• Why data science and the use of machine learning is essential to pharmaceutical, biotech, and medical device organizations
• How to use machine learning to understand outcomes before they occur
• Practical approaches for inference or prediction through machine learning
• Metrics to evaluate the performance of predictions made
Possibilities for the future of machine learning in clinical research
Partnership between CROs and Drug companiesKevin Lee
There is a new trend in the working relationships between CROs and Drug companies. The relationships evolve from the traditional transactional model to a partnership in the recent years. The partnership in the pharmaceutical industry is a new adventure to both CROs and Drug companies, and it also impacts programmers.
The partnerships will bring the new challenges and opportunities to programmers. We will work with not only our colleagues, but also employees from other vendors and clients. The partnership working environments will require the new set of rules and behaviors. The paper will discuss what kind of challenges and opportunities we will encounter and how we will resolve and succeed in the partnership working environments. The paper will specifically discuss the role of a project leader in CRO who are working directly with the clients and other vendors in the partnership environments. It will emphasize how important the culture is in the partnership environments and how the project leader helps to build the right cultures in the partnership environments.
Innovative Procurement Strategies for Thriving in a Networked EconomySAP Ariba
Building an agile procurement organization requires a focus on value, performance and capabilities.
Presented by Amy Fong – Senior Director, Procurement Executive Advisory - The Hackett Group
Moving the intellectual competence and operational dynamics of a firm to the hall of excellence wherein every key player and work process fit into intelligence best practices.
Even with the maturity of outsourcing, one of the most important yet often overlooked or minimized aspect of an outsourcing transaction continues to be the relationship management and governance model. The objective of the relationship management model is to ensure the anticipated benefits of an outsourcing relationship are realized in the most efficient manner. It must be based on the terms of the agreement and link the management processes of the two parties in order to govern the working relationship and achieve results. This article highlights the governance and relationship management model developed and implemented to support a sourcing strategy is the single most important factor in the realization of success in an outsourcing relationship. It also shares WGroup’s experience in advising on the creation and management of outsourcing relationships and governance and guiding clients in the development and implementation of sourcing strategies for existing contracts.
Bid to Win workshop for Seedbed - October 2015Matt Spry
If your business is supplying services or products to other organisations, and you want to grow, it is almost certain that you will have to navigate the minefield of tendering for new work. When done well successful bidding can help to scale your financial performance and impact quickly, but done badly and you risk wasting huge amounts of time and money.
The Bid to Win masterclass will give you:
- an introduction to bidding
- key principles for bidding to win
- an approach to bidding that can be applied to any sector or opportunity - the bid canvas
The aim of the session was to introduce attendees to a flexible and powerful approach to bidding that will keep your bids focused on what really matters to the buyer, whilst helping to manage the risks inherent in the tendering process.
Reference models a case study for healthcareReal IRM
This presentation is focused on the Healthcare Reference Framework which The Norwegian Healthcare Authority is sponsoring. Sarina looks at the Healthcare vision and business motivation driving the development and adoption of industry reference models and includes the business case for increased South African participation.
Meet our speakers and download this presentation(and more) at http://www.realirm.com/about-us/speakers-forum
Benefits management: it works, so why isn’t everybody doing it?
APM Benefits Management SIG Webinar
Tuesday 10th May 2016
presented by Richard Breese and John Thorp
5 Best Practices in CRO Selection for BiotechSeuss+
Unveiling the answers to the most burning questions in the business of the life science industry. In this slide, you will learn about selecting the best-fit CRO for your biotech company. Here is what you’ll learn: how to create the vision of your ideal CRO, how to have a Structured Process, how to anticipate and mitigate risks, techniques to promote and maintain Team Alignment, and the ins and outs of RFP Creation.
Learn more about how Seuss+ can help you at our website www.seuss.plus
Moving the intellectual competence and operational dynamics of a firm to the hall of excellence wherein every key player and work process fit into intelligence best practices.
Even with the maturity of outsourcing, one of the most important yet often overlooked or minimized aspect of an outsourcing transaction continues to be the relationship management and governance model. The objective of the relationship management model is to ensure the anticipated benefits of an outsourcing relationship are realized in the most efficient manner. It must be based on the terms of the agreement and link the management processes of the two parties in order to govern the working relationship and achieve results. This article highlights the governance and relationship management model developed and implemented to support a sourcing strategy is the single most important factor in the realization of success in an outsourcing relationship. It also shares WGroup’s experience in advising on the creation and management of outsourcing relationships and governance and guiding clients in the development and implementation of sourcing strategies for existing contracts.
Bid to Win workshop for Seedbed - October 2015Matt Spry
If your business is supplying services or products to other organisations, and you want to grow, it is almost certain that you will have to navigate the minefield of tendering for new work. When done well successful bidding can help to scale your financial performance and impact quickly, but done badly and you risk wasting huge amounts of time and money.
The Bid to Win masterclass will give you:
- an introduction to bidding
- key principles for bidding to win
- an approach to bidding that can be applied to any sector or opportunity - the bid canvas
The aim of the session was to introduce attendees to a flexible and powerful approach to bidding that will keep your bids focused on what really matters to the buyer, whilst helping to manage the risks inherent in the tendering process.
Reference models a case study for healthcareReal IRM
This presentation is focused on the Healthcare Reference Framework which The Norwegian Healthcare Authority is sponsoring. Sarina looks at the Healthcare vision and business motivation driving the development and adoption of industry reference models and includes the business case for increased South African participation.
Meet our speakers and download this presentation(and more) at http://www.realirm.com/about-us/speakers-forum
Benefits management: it works, so why isn’t everybody doing it?
APM Benefits Management SIG Webinar
Tuesday 10th May 2016
presented by Richard Breese and John Thorp
5 Best Practices in CRO Selection for BiotechSeuss+
Unveiling the answers to the most burning questions in the business of the life science industry. In this slide, you will learn about selecting the best-fit CRO for your biotech company. Here is what you’ll learn: how to create the vision of your ideal CRO, how to have a Structured Process, how to anticipate and mitigate risks, techniques to promote and maintain Team Alignment, and the ins and outs of RFP Creation.
Learn more about how Seuss+ can help you at our website www.seuss.plus
The satisfaction survey and research result impact are two powerful tools showing how the organization is perceived by partners. These tools provide strong feedback to the organization facilitating it to stay aligned with the expectations and needs of its partners. Additionally, they provide an overview of how the organization is fitting into the economical and social environment of its influence region.
www.FITT-for-Innovation.eu
J&J: Transforming Study Start-up in a Global Environment Veeva Systems
In this presentation, Lisa Rakebrand, Director Clinical R&D at J&J, discusses her team's vision to transform the way study start-up is conducted globally by leveraging Vault Study Startup to improve site collaboration, streamline site activation, and speed study start-up.
The Business Case: Evaluating Employee Engagement and Alignment with Organisa...The HR Observer
• Understanding the correlation between engagement levels and business performance
• How to establish employee engagement as a critical driver of business success
• Ensuring alignment throughout different phases and layers within the business
• Moving engagement from an add-on activity to core business driver
Rebecca Jeffs, Head of Talent and Reward, Serco
Benchmarking is the continuous process of comparing one’s business processes and performance metrics to industry bests and/or best practices from other industries. Dimensions typically measured are quality, time, and cost.
Improvements from learning mean doing things better, faster, and cheaper.
Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Di...Medpace
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Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
Our experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. Our team will walk you through the delays associated with these pitfalls and how to avoid them.
Considerations for the Next Wave of COVID-19 DevelopmentMedpace
What did we learn from the first wave of COVID-specific studies that can be applied to those studies that will follow? Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.
COVID-19 Product Development and Clinical Trials: Considerations from Europea...Medpace
Join experts from Medpace’s regulatory and operational teams in this webinar as they provide insights and considerations on how to accelerate product development for COVID-19 during different stages
Part 3: Rare Disease Clinical Development – Strategies for Ensuring Endpoint ...Medpace
n this free webinar, Medpace partners with Michelle Eagle of ATOM International, a provider of CE training for clinical trials across the world, to discuss approaches and steps that can be taken to ensure quality and integrity.
Getting Ahead of the Evolving Landscape in RadiopharmaceuticalsMedpace
In this webinar devoted to radiopharmaceuticals, the featured speakers will explore the scientific, operational and regulatory considerations for radiopharmaceuticals. With a focus on oncology, they will discuss the current regulatory landscape and how this impacts overall development programs. The speakers will explore the challenges of conducting radiopharmaceutical trials, offering insights into trial start-up, site selection and operational aspects to seamlessly execute these studies as part of clinical development plans.
Challenges and Considerations in Clinical Development of "Targeted Therapies"...Medpace
In this webinar, Medpace experts discuss key clinical, operational and laboratory considerations, lessons-learned, and best practices for accelerating the global development of safe and effective targeted therapeutics, using acute myeloid leukemia (AML) to highlight the complexities.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
Identifying High Performing Sites and Engaging PatientsMedpace
One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.
Challenges and Considerations in Designing and Conducting Immuno-Oncology Cli...Medpace
Given the accelerating pace of immuno-oncology clinical research, awareness of the specific challenges and considerations in designing and conducting successful trials for these new agents is critical.
Webinar: Oncology Trial Recruitment: Challenging Indications and Challenging ...Medpace
Medpace experts discuss how to overcome oncology recruitment challenges for clinical trials for specific populations, indications, and challenging studies.
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
Kseniya Leshchenko: Shared development support service model as the way to make small projects with small budgets profitable for the company (UA)
Kyiv PMDay 2024 Summer
Website – www.pmday.org
Youtube – https://www.youtube.com/startuplviv
FB – https://www.facebook.com/pmdayconference
VAT Registration Outlined In UAE: Benefits and Requirementsuae taxgpt
Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
https://viralsocialtrends.com/vat-registration-outlined-in-uae/
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
What are the main advantages of using HR recruiter services.pdf
Maximizing the Effectiveness of the Partnership with your CRO
1. FOCUSED. TRUSTED. GLOBAL.
EXPERTS
Maximizing the Effectiveness of the
Partnership with your CRO
Alita M Hassan, MPH
Director, Proposal Feasibilities
2. FOCUSED. TRUSTED. GLOBAL.
Drug Development over the past 13+ years
o 1996 – CRA – fully integrated teams – very efficient
and effective
Team collaboration
Autonomy
Execution
Strong Site Relations
o 2000 – Pfizer acquires Parke Davis
Monitors De-centralized
Start of outsourcing utilizing Functional Service Provider
model
o 2002 – all operations de-centralized and centralized
to New London, CT
Site selections, budgets, PM’s etc.
3. FOCUSED. TRUSTED. GLOBAL.
Drug Development over the past 13+ years
o Strategic Teams
Discovery
Early Clinical Development Teams
Similar to the model followed by industry today
o 2004 – Director on one of the Strategy Teams
left in Ann Arbor –utilized Full Service Provider –
as the continuity for the development of the
compound was of great importance
o 2008 – Ann Arbor site closure
4. FOCUSED. TRUSTED. GLOBAL.
Current State of Affairs
o Industry under tremendous pressure
International competition
Increased Regulatory Oversight
Issues around pricing
Investigational Product – Pipeline
o Pressures to make the right decision
Scientifically, Clinically, Regulatory and Commercial
o Pressures to execute correctly on those decisions
Selecting the right CRO – organizing
people, resources, and timelines
Getting things done on time, within budget, and with
quality
5. FOCUSED. TRUSTED. GLOBAL.
Different Outsourcing Models
o Full service
Integrated companies with global capabilities
Handling all aspects of operations
Advantage of integration
o Functional service provider
Focused on best in class
Research team with coordination internally or by a
lead CRO
Advantage that if done well it provides best in class
performance
6. FOCUSED. TRUSTED. GLOBAL.
Matching Your Needs
o Know the needs of your organization
Global CRO/niche CRO
Full service/functional service provider/combination
o Ensure matching synergistic organizational
systems
Internal expertise
Resources
Knowledge
Experience
7. FOCUSED. TRUSTED. GLOBAL.
Effective Outsourcing via Partnering
o Partnering on therapeutic basis with integration
of strategic consulting and operations
o Full service model preserves clear
accountability and avoids inefficient hand-off
between groups
8. FOCUSED. TRUSTED. GLOBAL.
Strategic Alliance
o Relationship between sponsor and CRO that is
managed by an executive team and not by the
study team directly involved in the project
o Two committees are identified:
An Operations Committee consisting of director level
management from each functional area. Responsible for
oversight of key performance metrics, process
improvement and first point of escalation for project teams
An Executive Committee consisting of senior managers
with responsibility for oversight of the Operations
Committee and development of strategic direction of
each organization and how it fits into the relationship
9. FOCUSED. TRUSTED. GLOBAL.
Alliance Operational Benefits
o Ensures that proper communication,
transparency of operational performance, and
timely escalation of essential decision making is
executed for achievement of success as
measured by the Sponsor
o Minimizes miscommunication, delays in decision
making, and distracting political agendas from
frustrating the project progress or setting the
wrong priorities
10. FOCUSED. TRUSTED. GLOBAL.
Alliance Operational Benefits
o Allows operational staff to focus on their primary
responsibilities and avoids micromanagement
of processes by Sponsor staff with limited
knowledge of processes and personnel at the
CRO
o Results in cost savings by avoiding cumbersome
reporting and management through multiple
study teams and resulting redundancy of effort
11. FOCUSED. TRUSTED. GLOBAL.
Alliance Operational Benefits
o Dramatically reduces costs in many instances
by providing a framework in which the CRO
can use appropriate risk management analysis
to collaboratively identify labor (cost) saving
processes tailored to the program
o Reduces costs by minimizing CRO business
development activities and Sponsor
management of multiple vendors
14. FOCUSED. TRUSTED. GLOBAL.
Demographics
Service provider respondents:
15
CRO
4
Imaging
8 Laboratory
2 Consulting
Other
71
15. FOCUSED. TRUSTED. GLOBAL.
Highlights of Study
Relationships, Relationships, Relationships…
o Achieve greater levels of efficacy in
outsourcing relationships
o Maintain higher standards for service provider
evaluation
o Utilize performance and relationship
management mechanisms
o Form strategic relationships to curtail
development and “to market” timelines
16. FOCUSED. TRUSTED. GLOBAL.
Increased Efficacy in Outsourcing
o Intensify delineation of expectations at study
inception phase
o Smaller budget + reduced headcount = bigger
results
o Performance/metric reporting
o Implement functional “Lessons Learned”
o Increase technology platforms for communication
* Better measurement of provider performance and
the use of preferred providers were ranked as the
highest priority for sponsors’ future work
17. FOCUSED. TRUSTED. GLOBAL.
Measurement Mechanisms
o Modify current KPIs to adequately evaluate the
service provider activity and performance
o Adjust to account for quality of deliverables
rather than strictly timing and quantity
o Set rigorous standards for justifying work as
“quality”
o Capture relationship metrics/KRIs to increase
efficiency
18. FOCUSED. TRUSTED. GLOBAL.
Have you Formed Strategic Partnerships?
Sponsor responses:
12
Yes
10
No
43
Don't Know
N/A
35
19. FOCUSED. TRUSTED. GLOBAL.
Have you Formed Strategic Partnerships?
Service provider responses:
Service provider responses:
7
7
Yes
16
No
Don't Know
N/A
73
20. FOCUSED. TRUSTED. GLOBAL.
Case Study in Partnership
o Partnering with the Sponsor, what went right?
Proposal
• Thorough review of protocol (protocol considerations)
• Study feasibility
• Realistic timeline estimates
Award
• Expectations
• Responsibilities
Execution
• Study start-up
• Site relations
• Recruitment process
• Adhere to timelines
Outcome
21. FOCUSED. TRUSTED. GLOBAL.
Case Study in Partnership
o Introduction of Sponsor and relationship
Roles and responsibilities
Empowerment and trust in team
Responsible and collaborative oversight of Sponsor
22. FOCUSED. TRUSTED. GLOBAL.
Case Study in Partnership
o Best practices from study
Study start-up
• Timelines meet initial deliverables
Recruitment
• Pre-screen at time of feasibility to ensure strong site
selection
• Initiate priority sites prior to investigator’s meeting
– Encourages healthy competition
• Relationship with sites
o Lessons learned
Study start-up
23. FOCUSED. TRUSTED. GLOBAL.
Case Study in Partnership
o Benefits to Sponsor in alliance model
Continuity and knowledge of processes
Efficiencies in costs
Reputation in industry
Competitive advantage in development timeline
24. A well thought out
strategic partnership
between a sponsor and
a CRO results in the
optimization of trial
quality, time, and
money
Many of times these things are in place because of previous positive relationships.
See astella presentation -
Description of the report – Dr. Katz was part of the executive committee
Who all did they reach out to- include number of each ?
Curtail development by initiating discussions on the next phase of development Phase I – II or II- IIIto fu etc. Filing of NDA all data in one place.. Easy build the application and pull all data together.
What does KPI/ KRI mean.
Based on the organziations internal review of their needs they decided to build an alliance with Medpace as they needed not only full service capabilities with global presence but medical and regulatory expertise as well. At time of RFP – internal medical review of the protocol and provides considerations. A feasibility is performed. Each one of these steps are crucial to a successfl partnership.
This relationship is no different than a marriage, things are never constant therefore the two parties must continually evolve to become better partners and communicate, communicate and communicate. One side does not take blame but both sidesa work together in solving the problem because at the end of the day we are both here to improve patient health by improving patient outcome.
With the extensive experiencein ROW submissions, medace was able to meet and come ahead of schedule in getting sites up and running. As medpace has built strong relationships with investigational sites we were able to work with these sites to pre-screen patients at the time of site feasibility. This allowed Medpace to select top tier sites in addition, allowed sites to pre-screen patients so once the trial was up and running all they needed to do was to line the patients up for Informed consenting and first patient visit. As we all know that investigator’s like to be over-optimistic with their enrollment numbers however investigator’s are realizing that the competitiion for trials is becoming harder and harder therefore it is no advantaget o them to overestimate and underperform as we will not go back to them. Our investigator’s seem to perform very well for us. Initiate 5 to priority site prior to IM to have these sites startrecruiting. This provides two advantages. 1. encourages healthy competition but also allows for these 5 investigators to discuss learnings and how to recruit for such a trial.
So in the end these are the benefits to a sponsor in an alliance model. Points above