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Programme

The program for the Outsourcing in Clinical Trials: Medical Devices USA 2017 Conference is underway. If you have a case study, or key message to deliver to this audience, please contact the Programme Director below with your proposal.

nadia.kim@arena-international.com
Telephone: +44 0207 936 6626

Overview

    • 08:50 - 09:20
      • Registration and refreshments

      • 09:20 - 09:30
        • Chairman’s opening speech

        • 09:30 - 10:00
          • Speaker

            Barathi Sethuraman – Vice President, Clinical Science and Study Management, ST. JUDE MEDICAL

          Developing a seamless protocol to avoid delays by accommodating the right requirements and expectations

          • Which portions of clinical strategy can companies outsource?

          •What are the appropriate inputs for study design?

          •When and how to make decisions about outsourcing?

          •What requirements and expectations should I keep in mind to ensure a seamless protocol?

        • 10:00 - 10:30
        • How to leverage expert oversight and management in critical areas to avoid hidden costs in conducting clinical trials

          •Trial Design – Too many companies hurry through trial design without critical and collaborative input from medical, regulatory and operational experts. If you don’t invest early you will likely pay later

          • Site Selection – Poor decisions can lead to lengthy start-up, lack-luster recruitment, and quality issues – all leading to time delays and higher costs

          • Data management/biometrics/medical writing – Ensure your data is processed expeditiously and reports are generated without delays; if not, it could lead to lost revenue for you

        • 10:30 - 11:00
          • Speaker

            Nagesh Uppuluri – Sr. Director – Global Professional Affairs and Clinical Education, MEDTRONIC NEUROVASCULAR

          Determining the destination for your global trial based on your business goals to balance quality, time and cost

          •Conducting in Europe first to learn about your product easier, faster and cheaper before US application

          •Starting from an English speaking country to minimize time spent on distribution set up and approval

          •Prioritizing countries which require local studies to sell the products in the countries to plan a study there

          •Prioritizing countries which FDA has highest regards as the first choices to obtain study data to support US application

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

          • 11:30 - 12:00
          • Considering challenges with executing a medical device trial to develop a study design to avoid them

            •Highlighting the difficulties with site selection to fine the niche area to find a site

            •Continuously working closely with health authorities to interpret the regulation well and meet the requirements

            •Starting a collaboration with CROs early to plan a smooth trial operation

            •Working with the right expert who can tailor their service to your needs and design a protocol that is unique to your study, size and method

          • 12:00 - 12:30
            • Speaker

              Rebecca McMillian – VP Clinical Development | Medical Device and Diagnostics, INC RESEARCH

            How to be Successful Transitioning Ongoing Clinical Trials to a CRO

            •Considering if you need to transfer the trial to a (new) CRO when facing overpromised delivery, requiring more resources or reached primary endpoint

            •Making the decision to transition to rescue the trial to meet expectations

            •Building a successful roadmap for transition to execute the process smoothly

            •Delivering a successful result with a good transition process execution

          • 12:30 - 13:00
            • Speaker

              Judy Skroback – Director of Clinical Research, SYNCARDIA SYSTEMS

            Choosing and implementing study and company appropriate EDC and eTMF systems to support safety and integrity

            •Assessing complexity of study design and matching to systems based on efficiency and cost-effectiveness

            •Evaluating needs and available in-house resources for managing data and regulatory documentation

            •Testing usability for investigational site staff and sponsor data/regulatory documentation management

            •EDC builds: Outsourcing or use of in-house resources (impacted by study complexity, system capabilities and costs)

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

            • 14:00 - 14:30
              • Speaker

                Al Pacino – President/CoFounder, BlueCloud® by HealthCarePoint

              Increasing the industry Sustainability by using patient inspired solutions with over 1.2 Million HCP Members

              •Learning why patients can no longer wait for the establishment or the culture to modernize the industry

              •Minimizing redundancy, waste and abuse Costs for Sites to reduce costs on regulatory requirements competencies, Sunshine Act – Value Transfer by creating a common global network for standardization including but not limited to clinical Scales -NIHSS, Rankin, and many others

              •Learning how patient inspired solutions are globally connecting healthcare and clinical research by empowering and enabling connectivity between sites, sponsors, CROs, IRBs and other industry stakeholders

            • 14:30 - 15:00
              • Speaker

                Nela Gonzales – Vice President of Regulatory Affairs and Quality Assurance, PRESBIA

              Strategically planning a PMA trial approach to run it economically for a smaller medical device company

              •Accomplishing quality study data to improve reimbursements and increase market access

              •Planning a global trial to gather study data faster to obtain a quick approval

              •Discussing the financial challenge to run a PMA study and how to manage budget better

              •Providing sufficient trainings and information to investigators to avoid data quality failures

            • 15:00 - 15:30
              • Afternoon refreshments and networking

              • 15:30 - 16:00
                • Speaker

                  Luis Vargas – VP Medical Affairs/Medical Director, REVISION OPTICS

                Medical Affairs approach to developing and implementing clinical studies (Phase I to IV)

                • Priming sites and surgeons for success with Training and Education

                • Strategic alignment of study objectives and endpoints to drive value and fill data gaps

                • Data delivery: collect, analyze and package data for success

              • 16:00 - 16:30
                • Speaker

                  Song Liu – Director, Clinical Trial Operations, NATERA

                Designing and executing clinical trials for screening tests in prenatal and oncology fields

                •Understanding the challenges in designing and executing clinical trials for screening tests

                •Comparing the difference between clinical trials for screening tests and clinical trials for traditional medical devices/in-vitro diagnostic tests

                •Running smooth trials for screening tests

                •Managing clinical trials with limited resources and budget

              • 16:30 - 16:40
                • Chairman’s Closing Remarks and End of Day one

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