Mitigating Risk, Improving Results: A Better Approach to Protocol Deviations
Webinars
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Accelerating Clinical Research
Clinical research has been continually transforming through the adoption of new pathways, tools, technologies and techniques. Events like Covid have accelerated the adoption of decentralized clinical trials (DCTs) substantially as per the research report published by GlobalData on “Clinical Trials: The Movement Towards Decentralized Clinical Trials” from 250 trials in 2012 to 1425 trials in 2022 (by Sep 2022). Another report by the Institute of Medicine (US) RoundTable on R&D found that an average clinical trial generates up to three million data points and counting. Such developments are increasing the complexity of data collection, cleanup, aggregation and analysis.
Clinical Research Organizations (CROs) and Functional Service Providers (FSPs) play substantial and unique roles in the conduct of clinical trials. These organizations are typically contracted to support hundreds, if not thousands of studies by pharma, biotech, med device, vaccine and consumer health organizations. They are posed with the challenge of reviewing clinical and operational data during the study, identifying any problems and addressing them sooner rather than later to continue to keep the study running. The increase in the 5 Vs (volume, velocity, variety, veracity and variability) of data calls for the adoption of modern technology to rein in the complexity and make the data available to drive real-time or near real-time decision making.
CROs and FSPs need technology platforms that meet certain criteria that are uniquely different from the typical sponsor needs. For example, ability to support multiple sponsors and their studies across diverse therapeutic areas and geographies, need for availability of data not only for internal users but to their sponsors, a highly interoperable platform to connect with diverse clinical ecosystems that their sponsors would have etc. Also, adoption of processes like RBQM/RBM is on the rise creating opportunities for these service providers to expand their offerings like central monitoring, risk-based data management etc. These evolving needs require agile technology platforms that can be configured to make the data and insights available for real-time decision making.
Many CROs and FSPs have successfully met these challenges, created opportunities for growth in the marketplace and are advancing clinical research. In this webinar brings together a diverse set of leaders representing large and small CROs as well as large and small FSP service providers.
Register now and discover the featured speakers’ perspectives and experiences in selecting and adopting a data and analytics infrastructure that brings faster time to insights managing multiple data sources.
Who Should Attend
- Clinical Data Management
- Biostatistics
- Statistical Computing/SAS Programming
- Data Science
- Central Monitors/Risk-Based Monitoring
- Data Review
- Medical Coding
- Clinical Safety
What You Will Learn
Attendees will:
- Understand the complexity involved in modern clinical trials, from a CRO and FSP perspective
- Learn from industry leaders on how they are meeting these challenges and creating opportunities for their respective organizations to succeed in the marketplace
- Explore the unique needs of CROs and FSPs, from a technology perspective, to gain access to data in real-time for making timely scientific and operational decisions
- Gain insights into the decision-making process in selecting the right platform for their clinical trial needs
- Identify outcomes/benefits that these companies have achieved in cycle time reduction, operational efficiency, cost competitiveness and faster time to market for drugs and therapies for their sponsors
Presenters
Ex Vice President, GDO Innovation Lead and Head, GDO India, Parexel
Mahesh Iyer currently heads the Innovation and Technology function for Parexel, and is also India Head for Global Data Operations. Mahesh Iyer has over 25 years of experience in research and development in healthcare and has been responsible for guiding many products through the development life-cycle throughout his career at Novartis, Bristol Myers Squibb and Boehringer-Ingelheim.
Prior to his current role at Parexel, Mahesh was a co-founder of Sineflex Solutions LLP, a consulting firm focused on enabling and accelerating innovation in the healthcare space. He was also the head of the BIRAC funded med-tech accelerator located at the Centre for Innovation and Entrepreneurship, IIIT Hyderabad. Mahesh continues to be responsible for mentoring startups in the medtech space, and helping them scale their products and solutions.
Mahesh brings a strong analytical mind-set, deep insights into healthcare development and a proven record of implementing innovative solutions in the healthcare domain. Mahesh is passionate about enhancing industry academia collaboration; he set up one of the first part-time Ph.D. program in Statistics for Novartis associates, teaches at a number of Indian universities and has chaired multiple conferences over the years. He is Past-President of the Indian Association for Statistics in Clinical Trials and Past-President of the International Indian Statistical Association, India Chapter. He was recently featured in the Top-100 AI leaders in India.
Apart from his functional activities, Mahesh has led various organizational developmental activities and trainings. He is a certified coach in the areas of emotional intelligence, assessment centers, and psychometric evaluations. Mahesh has completed his Ph.D. in Statistics from Temple University, Philadelphia.
Chief Operating Officer, LumaBridge
Lori McDermott RN, BSN, MSc, PMP is a driven and passionate clinical operations and drug development executive with nearly 25 years of industry experience. Ms. McDermott is currently the Chief Operating Officer of LumaBridge, a growing and cutting edge Clinical Research Organization specializing in the conduct of clinical trials in oncology. In this role, she leads the workforce and business strategies to support growth and profitability of the company while engaging with biotech and pharmaceutical clients to deliver their drug development programs.
Before joining LumaBridge, Ms. McDermott held the position of vice president of clinical development and regulatory affairs at Heat Biologics and Pelican Therapeutics, where she was responsible for building out a full clinical operations department to drive forward the clinical development of 4 novel oncology assets. In the years preceding her work there, Ms. McDermott held Director and Management roles across biotech, pharma, and CRO settings and developed expertise in creating and leading high performing teams.
Ms. McDermott began her career in the hospital, providing bedside care as a registered nurse before transitioning into the clinical research industry. Ms. McDermott is PMP® certified and holds a bachelor’s degree in nursing from Neumann College as well as a Master of Science from Drexel University School of Medicine.
Chief Delivery Officer, Biometrics Services, eClinical Solutions
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 25 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much at home scaling operations as she is in developing strategies that drive revenue growth. At eClinical Solutions, Katrina was recently promoted from Executive Vice President of Professional Services to Chief Delivery Officer. She has previously held various technical roles at Lockheed Martin Energy Group and Bayer. Katrina holds a Bachelor of Science degree in Computer Science from Alabama Agricultural and Mechanical University and a Master of Science degree in Computer Science with Advanced Applications from the University of New Haven. In her free time, Katrina is an active participant of Chief, a private network for women in senior leadership roles, Treasurer in her church where she oversees all financial aspects and a Member of the Delta Sigma Theta Sorority Incorporated, a not-for-profit organization dedicated to public service with an emphasis on programs that assist the African American community.
Executive Vice President, Global Operations, eClinical Solutions
Venu Mallarapu is a digital innovation leader with over two decades of experience in business and IT advisory, strategic consulting, relationship, and delivery management to global life sciences organizations. As eClinical Solutions’ Executive Vice President, Global Operations, Venu is responsible for strategic development to meet global demand for the company’s platform and service offerings. He brings his expertise in collaboration and building teams to drive adoption, market expansion and innovation of the elluminate Clinical Data Cloud and eClinical’s Biometrics Services, ensuring current and future clients recognize value as industry needs evolve. Venu is a subject matter expert in Clinical, Regulatory, Quality and Safety & Pharmacovigilance functions, and has delivered Strategy & Transformation Advisory Consulting to top global Pharma, Biotech, Vaccine, and Medical Devices clients. He has spoken at various Life Sciences and Tech industry events and is a recognized thought leader in R&D with published articles.
