• Definitions
• Recommendations from experts and regulators
• Risk based monitoring in practice
• Organization and people
• Processes
• Tools
• Governance

Speaker:

Isabelle Naëije
Assoc. Global Trial Director, GDO Trial Management Oncology
Novartis Pharma AG

One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.

Key topics for discussion will include:

• Understanding and addressing the needs of the patient during protocol design is a critical first step
• Data-driven recruitment strategies and precautions. An abundance of de-identified healthcare data can lead to spurious conclusions; data-driven recruitment requires an analysis of trends, historical metrics, global practices, and anomalies to identify the best performers.
• Relationships with site staff and Key Opinion Leaders are essential to facilitate patient recruitment strategies
• Insight into internal site dynamics, standard of care and country-specific regulatory and cultural limitations are critical to inform a sound recruitment strategy.

Speakers:

Catherine Palmer
Senior Clinical Trial Manager
Medpace

Miaesha Campbell
Associate Director, Patient Recruitment
Medpace

• Shared CTMS data from 13-member companies was analyzed
• The focus was to identify trends in site activation and enrollment across countries and therapeutic areas
• Key questions included:
  • What does the site activation curve look like?
  • What is the time from site activated to first patient consented?
  • What percentage of sites don’t enroll at all?
  • What is the variation by country and therapeutic area?

Speaker:

Lorena R. Gomez
Director, Global Study Start Up & Essential Documents, Global Site Management Operations
Allergan PLC

With drug development facing unprecedented challenges from increasing cost pressures and international competition, organizations are grasping for ways to do more with less. The savviest among today’s researchers are those that invest in developing a thorough understanding of the most common sources of clinical trial costs today, so they can better form a plan to reduce them. eClinical software plays a major role in this endeavor.

Join our webinar on May 15th and learn how sponsors, CROs, and site staff can gain the cost- and time-efficiency necessary to succeed in today’s clinical trial environment.

Key takeaways:

• Compare your clinical trial cost structure to industry benchmarks to understand where savings are possible
• Learn how to leverage modern clinical trial technology to reduce costs by eliminating fees, shortening timelines, reducing source data verification, and increasing trial volume
• Become an expert at projecting the return on investment of your eClinical software

Speakers:

Mike Novotny
Founder and CEO
Medrio

Johannes Hoech
Vice President of Marketing
Medrio

This presentation will review innovations expected to change the landscape of clinical trial supply and conduct in the years to come, and the efforts within and across industry to support their installation. This includes:

• Use of mobile healthcare technology to enable siteless clinical trials, improved patient monitoring, and reduced patient burden
• Use of electronic and digital labeling to improve supply chain flexibility
• Opportunities for use of Blockchain and digital platforms to enable secure data capture and sharing
• The potential for social robotics to play a role in patient engagement.

Speaker:

Matthew Moyer
Director, Clinical Supply Technology
MSD, USA

There are differing schools of thought when it comes to data capture, verification, and management. Some prefer paper based studies along with a manual verification process. While others prefer a purely electronic "intelligence" based method with fully automated error checking and verification. Others still, want a hybrid approach. Which school are you enrolled in and how do you fully leverage the myriad of technology options available to you today to achieve your goals?

Join our webinar on May 15th and learn how to employ the use of electronic data capture technology to streamline your clinical trials and still have it your way.

Key takeaways:

• Learn how to leverage technology while still conducting a paper-based trial.
• Learn how to implement intelligent data capture to streamline your trial and reduce or eliminate queries.
• Learn how to have the best of both worlds (paper and electronic).

Speakers:

Donna Hudi
Chief Marketing Officer
Phoenix Software International

John Brayman
Director, Domestic Business Development
Phoenix Software International

• The sad truth about Alzheimer’s Dementia
• EPAD (Early Prevention of Alzheimer’s Disease)– A New Era for Performing Prevention studies using a platform approach
• EPAD Consortium joining forces - Framework and Scene setting
• Building a Platform
• What are the operational challenges?
• What is the added value for pharma companies?

Speaker:

Katrin Haeverans
Clinical Scientist and External Affairs Director
Janssen (EMEA)