Developing Strong Partnerships to Ensure Success With Global Medical Device Trials 23-February-2017, OCT Burlingame www.genae.com With you, for you
Agenda 01 02 Identify the core group of stakeholders who will evolve throughout the course of the trial 03 04 Ensure that the infrastructure is adapted to deliver on the ambition of a global study Understand the landscape of a global medical device trial within the different regions Continuously measure of project progress and instigate pro-active adaptability based on experience and data analytics
Identify The Core Group of Stakeholders Who Will Evolve Throughout The Course Of The Trial Effective and open communication from the study start up Set up of frequent team meetings to discuss study progress. Define clear and realistic expectations from all stakeholders. Communicate any changes to the study plan that can affect study outcome.
Identify The Core Group of Stakeholders Who Will Evolve Throughout The Course Of The Trial The Sponsor or CRO identifies the team leaders involved in the study. Define and delegate the responsibilities of each of the stakeholders and the steps for escalating study related issues. Understand that the core group of stakeholders will evolve throughout the trial but through effective communication the impact on the trial can be quickly addressed.
Identify The Core Group of Stakeholders Who Will Evolve Throughout The Course Of The Trial Sponsor CRO Clinical Research Sites Project Management Monitoring Safety EDC Regulatory Stakeholders: Who s views and decisions will affect the outcome of the trial.
Identify The Core Group of Stakeholders Who Will Evolve Throughout The Course Of The Trial Pro-activeness Core Group of Stakeholders Effective Communication Delegation of Responsibilities
Understand the Landscape of a Global Medical Device Trial Within the Different Regions Regulators USA: FDA regulations (21CRF, FDA guidance) Europe EU - ISO 14155 clinical investigations of medical devices in human subjects (Council) Directives MEDDEV guidelines National requirements Worldwide: ICH-GCP: ICH topic E6 Guideline for good clinical practice, version published 2002
Understand the Landscape of a Global Medical Device Trial Within the Different Regions Clinical Research Sites Development of site selection qualifications Selection of sites sponsor has working relationships with Recommendation of sites that CROs have experience working with Contract negotiation timelines IRB/EC Approval timelines Addressing language barriers and cultural differences Site Selection Contract Negotiations IRB/EC Approval Site Initiation Enrollment
Understand the Landscape of a Global Medical Device Trial Within the Different Regions Time zones Global trials require proper oversight for the different time zones. Ensuring adequate coverage and availability of the team leaders for the different phases of the trial (from contract negotiation through study closure). Coordinating team meetings within the different time zones to ensure effective communication of study progress and or issue resolution. Considering time zones for site initiation and enrollment (during summer time enrollment might be slower due to vacations; summer time varies depending on the time zone of that region).
Ensure That The Infrastructure Is Adapted To Deliver On The Ambition Of a Global Study Communication plan Objectives To effectively provide study updates and study progress. To define appropriate escalation of issue resolution Stakeholders Define each of their roles in communication during the trial Describe way of communication (ex. Via email, fax) Global Ensure that the communication plan covers the different regions Communication plan will change as the trial progresses
Ensure That The Infrastructure Is Adapted To Deliver On The Ambition Of a Global Study Quality Management System Should effectively manage all of the documents, and activities that must be administered and controlled throughout the life of a clinical trial. Facilitates crossfunctional activities through the trial. It is a framework for defining and delivering quality outcomes, managing risk and continuous improvement on a global level.
Ensure That The Infrastructure Is Adapted To Deliver On The Ambition Of a Global Study Project plan Objectives Timelines Resources Associated Risks What is the desired outcome of the trial? Define projected study startup timeframe Deadline for IRB reviews and approvals Study team and delegated responsibilities EDC systems to be used Define the risk associated with conducting the protocol. Mitigation plan for any problems that arise.
Ensure That The Infrastructure Is Adapted To Deliver On The Ambition Of a Global Study Budget Regular review of study budget with project management team is key to ensure that the project is staying on budget, and to address any issues that could affect the study budget. Clinical Development Data Management Biostatistical Regulatory Clinical Study Site Subject Reimbursement
Continuously Measure Of Project Progress And Instigate Pro- Active Adaptability Based On Experience & Data Analytics Continuous Review of Key Performance Indicators (KPI) Dashboard 250 200 150 100 111 90 127 113 50 33 60 60 25 0 Sep'16 Oct'16 Nov'16 Dec'16 Patient Enrolled Subjects in EDC Total SDV
Continuously Measure Of Project Progress And Instigate Pro- Active Adaptability Based On Experience & Data Analytics Strategic Data Review and Discussion of Action Plans Will provide accurate measure of project progress allowing the project team to: Address early on enrollment issues that can be addressed either by additional follow-up with study sites, or review enrollment criteria on the study protocol. Evaluate low enrolling or poor performing sites to determine if they can continue in the study. Focus of monitoring activities based on the study data available. Continuous review and discussion with management team of study progress and escalate as appropriate to pro-actively address any issues.
US experience With experience of studies involving 200+ US sites, genae has the expertise you need to conduct trials of all sizes and complexity worldwide.
genae can support your global and local project. With you, for you. genae Americas Inc Cleveland, OH genae associates Antwerp, Belgium genae International AG Zürich, Switzerland genae Japan GK Tokyo, Japan genae NY New York, NY genae SF San Francisco, CA genae UK Ltd London, UK genae Germany GmbH Frankfurt, Germany genae Poland Warsaw, Poland genae Gulf FZ LLC Dubai, UAE genae CoreMed - Strategic Alliance Beijing, China
Q&A
www.genae.com thelma.bueno@genae.com Accelerating innovation through collaborative insights & global expertise with results that matter Dedicated to Medical Devices, delivering what is promised With you, for you