The focus on delivering patient-centric practices to improve clinical trial participation by reducing the burden on patients is the cornerstone of clinical research excellence. Over the last few years, there has been a shift to bring the clinical trial to the patient’s home, an evident disruption of historical clinical trial conduct practices. While adoption has not been widespread, the COVID-19 pandemic has rapidly turned this ideology into a necessary reality.

Veristat understands how challenging it is to pivot to virtual and hybrid clinical trials successfully. With multiple virtual trials running right now, the company has designed a customized virtual/hybrid trial ecosystem that satisfies regulators, sponsors and the patients’ needs.

Join this webinar to hear panelists share lessons learned and recommendations for designing protocols that enable flexibility in your virtual trials’ conduct.

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Speakers

Shaheen Limbada, Executive Vice President, Global Clinical Operations, Veristat

Shaheen Limbada has over 20 years of experience conducting clinical trials in both the sponsor and CRO setting. He is a pioneer in rapidly implementing virtual clinical trial strategies into risk management, project management, patient recruitment, clinical study conduct and governance. Mr. Limbada believes that the cornerstone of clinical research excellence lies in delivering patient-centric practices to improve clinical trial participation by reducing patient burden. Mr. Limbada graduated from the University of Toronto and quickly began his career running clinical trials with AstraZeneca Canada Inc.

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Brenda Muskat, Global Clinical Project Director, Veristat

Brenda brings expertise from over 15 years of managing global phase I-IV and NIS clinical trials at both large pharma and CROs. She is passionate and innovative at implementing novel approaches to maximize country-level patient/site commitment, and minimizing start-up times, costs and patient retention rates. Brenda was a lead on the clinical trials for three FDA approved therapies for Cardiovascular Disease, Cancer and Diabetes. She completed MSc. level coursework in Bioinformatics at the University of Manchester in Great Britain and earned her Honors Bachelors of Science (BSc) in Human Biology/Genetics at the University of Toronto, in Canada.

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Amy Bossons, Senior Project Manager, Veristat

Amy is an established Senior Project Manager with 10 years of experience in the CRO setting and CTU setting managing academic-led clinical trials. Additionally, Amy has experience from a Research Network perspective and has spent many years at site level coordinating the delivery of trials directly to the patient, managing a large portfolio of trials. Amy has project managed global clinical trials in various therapeutic areas including Rare Disease (Endocrinology, Hypoparathyroidism); Neurology (Parkinson’s Disease); Enzyme Replacement Therapy (Mitochondrial Disease); Immunology (Paediatric Gene Therapy); Surgical, Medical Device; Mental Health; and her most extensive experience is in Oncology. She graduated from Manchester Metropolitan University in the UK.

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Who Should Attend?

Clinical operations titles (Heads, VPs, Directors) at biopharmaceutical firms
Project managers (Heads, VPs, Directors) at biopharmaceutical firms
Data management, statisticians/programmers (Heads, VPs, Directors at biopharmaceutical firms)
Regulatory affairs titles (Heads, VPs, Directors) at biotech firms
Emerging small and mid-tier biotech firms – CEO, CMO, COO or any regulatory titles
Procurement titles at mid-size to larger biopharmaceuticals

What You Will Learn

In this webinar, participants will learn about:

Lessons learned with examples from ongoing trials that went virtual and those planned with virtual/hybrid components right from the start
The importance of protocol design up-front to enable flexible virtual trials, combining a customized mix of at-home, local and on-site activities
Understand the pros and cons of different virtual technologies and strategies

Xtalks Partner

Veristat

Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years’ experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared nearly 100 marketing applications for approval with global regulatory authorities in the last ten years.

Veristat’s focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. We apply this knowledge base every day to solve any clinical program’s challenges, from the simplest to the complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives.