Evolving to electronic learning and management for measurable impact
Clinical trial complexity has increased significantly over the last 10 years. The number of mandated procedures required to be executed by the site has increased on average by 50% and the number of data points that must be collected per trial has increased by 60%.
This complexity has increased the operational burden for sites participating in trials and the associated risk of protocol non-compliance, deviations and violations. However, the shift to on-line training and automated processes that would support sites in reducing administrative burden and improve efficiency has been slower than expected. The outbreak of COVID-19 has also accelerated the need to look at how digital solutions can reduce the risk of disruption when on-site training is not possible.
Join ICON to hear the site and sponsor perspective, explore the potential barriers in adopting an on-line learning solution and find out how to overcome the challenges in deployment. You will also learn how a site portal solution has been deployed to effectively manage training and supporting the continuity of site operations during the evolving environment of the COVID-19 pandemic.
Topics covered include:
- A day in the life of an investigative site - understanding the burden at site level
- Training and managing site communications - the sponsor perspective
- Moving to a digital learning management solution - overcoming the challenges and reaping the benefits
- Case studies demonstrating the value of integrated site learning management
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Amit Gulwadi
Amit is responsible for leading the transformation of Alexion’s clinical development operations and Quantitative sciences which involves use of several cutting edge technology, analytics, partnership programs with a variety of partners and process redesign with a goal to accelerate the execution of the portfolio, drive patient centricity into clinical development, unlock value of data& strengthen risk posture. Amit holds a Masters Degree in Neuropharmacology from Massachusetts College of Pharmacy in Boston, Masters in Pharmacognosy from University of Mumbai (India) and Bachelors in Pharmacy from University of Pune (India).
Dr. Jonathan P. Wilson
Dr. Wilson is board certified in Family Medicine. He has completed more than 200 trials as Principal Investigator, and has worked with PMG Research since 2006. He completed FDA’s Clinical Investigator Training in 2009. Areas of experience include but are not limited to Asthma, Device, Fibromyalgia, Gout, Hypercholesterolemia, Hypertension, Hypertriglyceridemia, Low Libido, Migraine, Obesity, Osteoarthritis, Smoking Cessation, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, and Vaccine. In addition to his work as a PI, Dr. Wilson serves as a Sub-I for other specialties including Dermatology, GI, and Urology.
Andrew Stebich
Andrew has a Bachelor of Science in Psychology. He joined PMG in October, 2014. His areas of expertise include: Migraine, Type II Diabetes, Weight Loss/Obesity, Fibromyalgia, Low Back Pain, Smoking Cessation, Influenza Vaccine, RSV Vaccine, Ulcerative Colitis, Crohn’s Disease, IBS-C, Hypercholesterolemia, hypogonadism, NASH, Hypertriglyceridemia. Andrew has experience with 15+ trials using.
Jessica Speece
Jessica has a B.S. in Exercise Science, and joined PMG Research of Winston Salem in 1999. She was a finalist for the Clinical Researcher of the year competition in 2013 and Site Team competition in 2017 & 2018. Areas of experience include Weight Loss/Obesity, Hypertension, Diabetes, Hypercholesterolemia, Pediatric Vaccine, Influenza Vaccine, Zoster Vaccine, Acne, Actinic Keratosis, Atopic Dermatitis, C-Diff, and Device trials.