Moving Beyond 10 Steps to Clinical Study Startup

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Drug Discovery & Development,
  • Tuesday, November 30, 2021

Until recently, the study startup portion of clinical trials has not benefited from innovation, essentially remaining manual or heavily rooted in Excel spreadsheets, causing this complex process to seriously underperform. The 10 steps to clinical study startup eBook, based on the directives in ICH E6(R1), helped define the site-specific activities at the outset of a clinical trial and to this day remains a very popular download.

Today, study startup functions and job roles are more commonplace at sponsor and CRO organizations, but despite this, clinical operations teams are drowning in data but starving for information at a time of intense pressure to speed up clinical trials and restrain costs.

The average cost of drug R&D is now estimated to be $2.9B by Tufts CSDD — this is unsustainable. Globalization (multi-country studies), the changing regulatory landscape (ICH E6(R2)/(R3), EU 536/2014, etc.), matrix organizational changes and non-traditional trial designs (e.g., decentralized clinical trials) have forced the industry to rethink their approach to study startup. These traditional steps need to be expanded upon, collapsed and fit for purpose. But, how?

In this webinar, featured speakers will explore:

  • Understanding the operationalization of ICH E6(R1)
  • The limitations of only 10 steps in multi-site and multi-country trials
  • Why the 10 steps will not solve the current $2.9B problem or align with ICH E6(R3) efficiency objectives
  • The benefits of proactive upfront planning in the clinical development plan prior to financially approving the protocol
  • How new techniques and technology (e.g., quality by design, parallelization, machine learning, etc.) can help improve the operational efficiencies of study startup

Register for this webinar to learn about a modern approach to study startup that addresses today’s drug development challenges.

Speakers

http://Gareth%20Milborrow,%20ICON;%20ACRO%20Committee%20Member

Gareth Milborrow, SVP of Feasibility, Site ID & Start-Up, ICON; ACRO member company

Dr. Gareth Milborrow is SVP of Feasibility, Site ID and Site Activation at ICON. He is also a medical doctor and data expert with over 15 years of clinical trial experience, including several years as an investigator in cardiovascular clinical trials. Dr. Milborrow’s combined clinical, data and operational experience is enabling ICON’s accelerated start-up timelines and Site Intelligence strategy.

Message Presenter
http://Lorena%20Gomez,%20AbbVie

Lorena Gomez, Senior Director, Global Study Start Up, PRO Management and Digital Implementation, AbbVie

Lorena has over 25 years of experience in clinical research, with more than 8 years specializing in Study Start Up. She began her career as a Phase I study coordinator and went on to hold monitoring and project management positions at Parexel and AstraZeneca, clinical operations and start up leadership roles at Abbott and AbbVie and was the Director of Study Start Up at Allergan before returning to AbbVie in 2020 as Sr. Director of Global Study Start Up, PRO Management and Digital Implementation. Lorena holds a BS in Microbiology, a BA in Molecular Biology, and was an NIH fellow in the University of Texas at Austin Pharmaceutics PhD program.

Message Presenter
http://Andrea%20Ochoa,%20Premier%20Research;%20CRO%20Forum%20Committee%20Member

Andrea Ochoa, VP of Global Study Start Up, Premier Research; CRO Forum member company

Andrea Ochoa is Vice President, Global Study Start-Up at Premier Research. Ms. Ochoa has more than 19 years of clinical operations experience in a variety of roles, specializing in study start-up for the past 10 years. In her current role, she oversees Premier Research’s start-up function while providing expert advice and strategies to operationalize and navigate the complex global regulatory and start-up environment.

Prior to joining Premier Research, Ms. Ochoa held several positions of increasing responsibility at MDS Pharma Services and INC Research. She has a master’s degree in cognitive behavioral therapy from the Luria Institute in Madrid, Spain, and bachelor’s degrees in psychology (National Distance Education University, Madrid) and law (Complutense University of Madrid). Ms. Ochoa is certified as Lean Sigma Green Belt since 2009.

Message Presenter
http://Kirill%20S.%20Soldatov,%20PSI%20CRO

Kirill S. Soldatov, Director of Process Improvement, PSI CRO

Kirill Soldatov holds a Medical Degree in Cardiology, and before joining PSI in 2003, he worked as a cardiologist and a sub-investigator at the St. Petersburg Institute of Cardiology. At PSI, Kirill has worked in clinical operations and project management and is now leading the PSI process improvement department. In this capacity, he spearheaded the development and implementation of a risk-based monitoring strategy as part of the integration of ICH E6(R2) into PSI business practices.

Message Presenter
http://Tina%20Karunaratne,%20Orum%20Therapeutics

Tina Karunaratne, Head of Global Clinical Operations, Orum Therapeutics

Tina Karunaratne has over 20 years of leadership experience in clinical operations and project/program management at small (Ocata), mid-sized (Organogenesis, EUSA) and large (Vertex, Astellas) companies. She is currently the Head of Global Clinical Operations at Orum Therapeutics. She has presented at several major conferences on clinical project management, including planning for study startup. She was also an adjunct professor of project management at Regis College, Weston, MA. Tina has a Doctoral degree in Law and Policy from Northeastern University and a Master of Science in Regulatory Affairs (Drugs, Devices, and Biologics) from Regis College.

Message Presenter
http://Jennifer%20Peterson,%20Syneos%20Health;%20ACRO%20Committee%20Member

Jennifer Peterson, Executive Director, SSU & Regulatory, Syneos Health; ACRO member company

Jennifer Peterson has over 20 years’ experience in the CRO industry. Jennifer joined Syneos Health in 2013 and currently serves as Executive Director, overseeing the Americas Site Start-Up Team. In this role, Jennifer leads a team of over 200 regulatory specialists and managers in successfully activating ~3,000 clinical sites annually in support of the organization’s mission to accelerate the delivery of therapies that impact health worldwide. Prior to joining Syneos Health, she held leadership positions with three large CRO/AROs all within site start up business units, with a concentration in contract/budget negotiations and regulatory compliance for participating physicians and researchers in clinical trials.

Message Presenter
http://Elvin%20Thalund,%20Oracle%20Health%20Sciences

Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences, ACRO member company

Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect at Oracle Health Sciences, supporting their effort to optimize study start up. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.

Message Presenter

Who Should Attend?

Sponsor and CRO roles who are responsible for:

  • Country and site identification, feasibility assessment, selection, and activation
  • Clinical data management, collecting and evaluating trial metrics
  • Project management of studies, process optimization, and operational excellence

What You Will Learn

In this webinar, featured speakers will explore:

  • Understanding the operationalization of ICH E6(R1)
  • The limitations of only 10 steps in multi-site and multi-country trials
  • Why the 10 steps will not solve the current $2.9B problem or align with ICH E6(R3) efficiency objectives
  • The benefits of proactive upfront planning in the clinical development plan prior to financially approving the protocol
  • How new techniques and technology (e.g., quality by design, parallelization, machine learning, etc.) can help improve the operational efficiencies of study startup

Xtalks Partner

Oracle Health Sciences

As a leader in Life Sciences cloud technology, Oracle Health Sciences’ Clinical One and Safety One are trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance. With over 20 years’ experience, Oracle Health Sciences is committed to supporting clinical development, delivering innovation to accelerate advancements, and empowering the Life Sciences industry to improve patient outcomes. Oracle Health Sciences. For life.

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