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Outsourcing in Clinical Trials New England

October 12, 2022
October 13, 2022
ET
The Westin Boston Seaport District, 425 Summer St, Boston, MA 02210

This event will open with Shaheen Lakhan and Laura Taraboanta from Click Therapeutics presenting on Enabling Innovation in Spite of Barriers. Audience members can get involved with numerous interactive sessions, such as a panel discussion on ‘What the clinical trial industry really wants from its service providers- reversing the conversation’.

Arena International is thrilled to welcome Craig Lipset (Advisor and Founder, Clinical Innovation Partners), who will be giving a Keynote presentation on Day 2, discussing Democratizing Decentralized Trials, including how innovative solutions can be accessible for all. Join us at 2pm EST for Craig’s insights!

Our Boston event boast 4 tracks, meaning there truly is something for everyone:

  • Clinical Operations & Outsourcing
  • Decentralized & Hybrid Trials
  • Rare Disease Trials
  • Technology, Innovation & Devices

The programme will, through a variety of interactive session formats, offer insight on promoting successful collaboration between the clinical trials community and once again offer attendees practical take-aways that they can apply to their own studies.

Come see us at booth #28!

Session Information:

Title: Training and Support in a Decentralized Clinical Trials (DCT) World

Date: Wednesday, October 12th, 2022

Time: 4:15 p.m. – 4:45 p.m. EDT

The emergence of DCTs has inspired a new way of thinking about clinical research. As the industry looked to solve the problems created by COVID-19, new technologies, approaches, and ways of thinking emerged. One of the areas that needed re-imagination was the training and support we provide for our patients.

Typically, in a traditional clinical trial site personnel are available to provide training and support for patients as they encounter the technologies and tests required to deliver the data for clinical trials. As DCTs became prevalent, our patients were left to manage these challenges on their own, often isolated in their houses.

This panel will discuss aspects of these challenges including:

  • Realities of patient-focused training and support in the decentralized trial environment
  • Best practices, common errors, and solutions that allow you to consider the support and training of your patients in your trial design
  • Considerations for monitoring the success of your training and support to proactively avoid issues resulting from patients misunderstanding proper trial participation

Speakers

Tim Kulbago headshot

Tim Kulbago

Senior Vice President of Integrated Customer Solutions and Trial Oversight at Clario

As Senior Vice President of Integrated Platforms and Trial Oversight at Clario, Tim is responsible for delivering solutions that bring together the Clario portfolio of products to provide exceptional experiences for patients, sites, and sponsors. His team focuses on minimizing the burden for patients and sites through the delivery of intuitive streamlined applications by uniquely combining traditional eCOA, Respiratory, Cardiac Safety and Imaging interactions in a harmonized ecosystem. Tim has 25 years’ experience of working in healthcare, with a focus on the medical imaging industry. He has held many executive positions, including Product Line Executive, CTO, CSO, and also as President and CEO at ImageIQ, where he led the company’s deployment of software engineering, high-resolution imaging and custom-tailored image analysis, to support the delivery of high-quality imaging data for clinical research

Anne F. Lewis, M.S.

Director, Strategic Initiatives at CorEvitas

Ms. Lewis is an experienced and versatile professional with over 25 years in the clinical research industry across a variety of therapeutic areas using a range of methodologies and strategies. Her experience includes the design and implementation of phase 3 and 4 studies as well as large-scale global safety and effectiveness registries, clinical trial simulations and digital app experience workshops. She has led numerous qualitative research projects involving patients, caregivers and healthcare professionals.  In addition, Ms. Lewis has spearheaded the development of educational materials and communications for patients and physicians, as well as oversight of several large-scale longitudinal survey-based projects. In addition, she has created content for and scripted multiple Investigator Meetings as well as Study Team launch meetings.  She has held positions within the healthcare sector, CROs and pharmaceutical industry, as Project Director, Director of Late Phase Research, Director of Health Economics and Outcomes Research, Senior Project Manager, and Senior Clinical Administrator for a research foundation.