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
Maximizing the Effectiveness of the Partnership with your CRO
FOCUSED. TRUSTED. GLOBAL.EXPERTS Maximizing the Effectiveness of the Partnership with your CRO Alita M Hassan, MPH Director, Proposal Feasibilities
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.
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
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
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
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
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
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
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
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
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
FOCUSED. TRUSTED. GLOBAL.EXPERTS 2009 Avoca Report The State of Clinical Outsourcing
FOCUSED. TRUSTED. GLOBAL. Demographics Service provider respondents: 15 CRO 4 Imaging 8 Laboratory 2 Consulting Other 71
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
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
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
FOCUSED. TRUSTED. GLOBAL. Have you Formed Strategic Partnerships? Sponsor responses: 12 Yes 10 No 43 Dont Know N/A 35
FOCUSED. TRUSTED. GLOBAL. Have you Formed Strategic Partnerships? Service provider responses: Service provider responses: 7 7 Yes 16 No Dont Know N/A 73
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
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
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
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
A well thought out strategic partnershipbetween a sponsor and a CRO results in the optimization of trial quality, time, and money