What Does it Take to Successfully Execute Large, Global, Phase III Programs?

Clinical Trials, Life Sciences, Patient Recruitment and Retention, Pharmaceutical,
  • October 03, 2017

INC Research/inVentiv Health leaders reveal a proven method to thrive in this complex environment

Each year, the process of developing new drugs and new therapies for market becomes more and more complex. A diverse group of stakeholders including sponsors, CROs, regulatory bodies, patients, physicians & hospitals, ethics committees, vendors, etc., each have their own specific needs and requirements which need to be considered. A constantly changing environment with new regulations, new treatment options and competing investigational therapies compounds the issues further.

In addition, the complexity of managing a trial goes up exponentially when considering a large global study where geopolitics, differing regulatory requirements, cultural and language differences, variances in standards of care, socioeconomics and much more must be taken into consideration. It’s a challenge many clinical developers face in today’s global marketplace, but one that many times must be undertaken to access the limited patients available to meet enrollment targets.

So, what does it take to successfully execute a program of this nature? Clifford McIntosh, Vice President, Strategic Alliance Management, INC Research/inVentiv Health and Alexandria Wise-Rankovic, Ph.D., Senior Vice President, Clinical Development, CNS, INC Research/inVentiv Health, will break down some of the best practices and crucial elements for executing programs in this challenging environment.

Speakers

Clifford McIntosh, Vice President, Strategic Alliance Management, INC Research/inVentiv Health

Cliff has nearly two decades of clinical research experience, including seven years of senior level roles in operational delivery and oversight of clinical trials. He has managed the operational execution of multiple global Phase I – III trials in a variety of indications; provided operational oversight for more than 30 large Phase III global studies and programs, and overseen strategic development and launch of successful partnerships with large pharma and mid-size biotech companies. Cliff is committed to developing innovative solutions to mitigate risk and bring valuable therapies to patients.

Alexandria Wise-Rankovic, Ph.D., Senior Vice President, Clinical Development, CNS, INC Research/inVentiv Health

Dr. Alexandria Wise-Rankovic is Senior Vice President of CNS Clinical Development at INC Research/inVentiv Health. Dr. Wise-Rankovic is an executive leader who has worked in clinical research for more than 25 years and brings a broad base of both industry and academic experience to her role. She is a licensed clinical psychologist with doctoral specialization in clinical neuropsychology. Alex’s clinical training and work history spans all ages and most indications in neurology, psychiatry, analgesia, and peri-operative procedure. She serves as a consultant to the scientific and pharmaceutical community, having served on advisory boards as a subject matter expert in schizophrenia.She has extensive clinical trial experience with the severe psychiatric population. In her current role, she represents INC Research/inVentiv Health’s CNS Business Unit as Customer Relation Executive (CRE) as a collaborator with pharmaceutical companies on program designs, strategic development, and governance. She provides operational oversight and direction to large, international, pivotal programs.

Who Should Attend?

  • Project leads
  • Pharma/biotech operations executives
  • Clinical research professionals planning to conduct or currently conducting large phase III clinical programs

Xtalks Partners

INC Research/inVentiv Health

INC Research/inVentiv Health (Nasdaq:INCR) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to address new market realities where clinical and commercial share expertise, data and insights to accelerate biopharmaceutical performance. With more than 22,000 employees and the ability to support customers in more than 110 countries, our global scale and deep therapeutic alignment enables INC Research/inVentiv Health to help customers successfully navigate an increasingly complex environment. For more information on our Raleigh, N.C.-based company, visit incresearch.com or inventivhealth.com.

The company was ranked a “Top CRO to Work With” among the top 10 global CROs in the 2017 CenterWatch Global Investigative Site Relationship Survey. Our purpose is Shortening the Distance From Lab to Life™ – creating better, smarter, faster ways to speed important therapies to market.

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