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Programme

The program for Outsourcing in Clinical Trials: Medical Devices USA 2018 Conference is underway. If you’d like to get involved we’d love to hear from you:

Email: Jisong.seo@arena-international.com
Telephone: +44 (0) 207 936 6607

Overview

    • 07:45 - 08:20
      • Registration and Refreshments

      • 08:20 - 08:30
        • Chair's Opening Remarks

        • 08:30 - 09:00
          • Speaker

            Frank Jaskulke – VP Members Services, Medical Alley Association

          Examining the state of Medical Alley - The Times, they are a changing?

          • Exploring changes in healthcare delivery and payment to be prepared in every facet of product commercialization including clinical research

          • Assessing the impact of new regulations in product registry – time, cost and outsourcing market

          • Investigating how Minnesota is doing given these changes and what adaptations companies are making to win in the emerging healthcare environment

        • 09:00 - 09:30
          • Speaker

            Royth Von Hahn – Vice President Medical and Health Services, TÜV SÜD America

          Mapping the new European Regulation – Adjusting studies for MDR compliance

          • Analysing documentation, process and governance needs to adjust for future requirements

          • Understanding the direction of regulatory changes within EU and the drive towards worldwide uniformity

          • Deconstructing compliance with data acquisition to avoid changes to your clinical study

          • Creating closer connections between Post Market Surveillance and your clinical study team to maximise your study outcomes

        • 09:30 - 10:00
          • Optimizing internal and outsourced trial staff for effective trial management

            • Inventorying overall personnel profiles and tech support needs

            • Mapping internal and outsourcing capabilities and personnel against requirements

            • Assessing budget and timelines associated with internal and outsourced options

            • Integrating post market studies and market support plans for transition from clinical to commercial phase

          • 10:00 - 10:30
          • Key to Trial Success: Don’t Underestimate the Role of the Clinical Trial Manager

            The Clinical Trial Manager (CTM) plays a critical role in advancing your clinical research. We’ll review five areas of execution that can impact clinical trial success:

            • Recruitment and Retention - faster enrollment with fewer dropouts

            • Vendor Management - ensure outside vendors are up to par

            • Functional Area Plans - integrate all areas of the trial

            • Risk Management - understand where risk could be and prepare

            • Communication - keep lines open for efficiency

          • 10:30 - 11:00
            • Morning refreshments and networking

            • 11:00 - 11:30
              • Speaker

                Rupa Dash – Director of Clinical Affairs, Global Kinetics Group

              Establishing communication protocols with your CROs for clinical, administrative and financial matters

              • Define communication channels and go-to personnel for both client and CRO in advance

              • For international studies, verify corporate and field language capabilities and materials are present

              • Conduct post study survey from both client and CRO perspectives assessing effectiveness of communication process noting successes and breakdowns

            • 11:30 - 12:00
              • Speaker

                Terry Noel – Sr Clinical Research Specialist, Medtronic

              Resolving Product Field Crisis, Poorly Performing Center or Client-CRO Tensions – What can happen and how to prepare in advance

              • How to address a product issue or patient injury - lines of responsibility and communication protocol

              • Managing a non-responding center or one with submitting partially completed reports – does Client or CRO address the situation and how and when

              • Resolving clinical differences of opinion or continuous issues between client and CRO

              • Interpreting trial performance by encouraging regular face-to-face discussions with your service provider

              • Working with vendors for precise budget management and for early warning if extra resources need to be found

            • 12:00 - 12:30
            • Clincial Trial Strategies on a Limited Budget: Keys to a Cost-Effective & Successful Trial

              • Completing entire product cycle analysis early to avoid the need for additional trials and clinical data gathering

              • Exploring new software systems to speed up data management

              • Considering investing in high-tech CROs who can multi-task from data management to medical writing

              • The benefits of working with Boutique CROs who can tailor their services to your needs compared with cheaper suppliers

            • 12:30 - 13:00
              • Session reserved for Syneos Health

              • 13:00 - 14:00
                • Lunch and networking

                • 14:00 - 14:30
                • [Case Study] Challenges in the Planning and Execution of Early Feasibility Studies

                  • Evaluating the FDA’s EFS program and the essential factors necessary for establishing protocols

                  • Underlining the considerations that need to be taken into account when deciding to conduct EFS studies outside of US to avoid delays during the study

                  • Investigating challenges for EFS studies done in multiple locations

                  • Including regulatory consultancy and data monitoring to ensure the trial stays on track

                • 14:30 - 15:00
                • [Case Study] How did we prepare pre-clin trials from funding to regulatory compliance

                  • TBC

                • 15:00 - 15:45
                • [Panel] Early stage product development: Large and small company Best Practices

                  • Funding clinical trials – large company versus start-up process and demands for funding clinical trials

                  • Scientific vs medical vs marketing vs reimbursement clinical trial goals

                  • VC approaches to clinical studies and importance in funding for start-ups

                  • How to present clinical trial plans to venture capitalists

                  • The role of angel investors in sponsoring early product trials

                • 15:45 - 16:15
                  • Afternoon refreshments and networking

                  • 16:15 - 17:45
                    • Speaker Hosted Roundtables

                      • Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practices and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts, the 2018 roundtable sessions will be focused on the overarching theme of ‘Utilising Data and New Tech in Medical Device Trials’. Each roundtable will focus on a specific aspect of exploring new technologies in clinical trials and enable you to discover best practices and overcome key challenges in clinical data management. Each roundtable session lasts for 45 minutes, and delegates may attend 1 roundtable

                      • Defining a global regulatory strategy to prepare for strengthened data privacy as a result of the GDPR regulation

                      • Developing best practices for communicating with international sites through communication technologies to ensure engagement

                      • Expecting artificial intelligences influence in trial execution and discussing how to prepare for it

                      • Exploring clinical data management systems to ensure accuracy and reliability of data

                      • Exploring the use of real world clinical evidence to support expanding claims for the FDA Laurie Lynch – Speaker

                      • Investigating EDC systems for your study to simplify your workflow

                    • 17:45 - 18:00
                      • Chair’s summary and close of conference

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