Take a New Perspective on Compliance

ON DEMAND

Site Perspective — What Sites Really Think of Your Study Processes

Learn how to include local site reality in how you design your study. In this session, you will get the chance to hear from experienced site coordinators about what sites really think of your study processes. This will include how to keep your study moving during the COVID-19 pandemic.

Sites are highly motivated by the needs of their patients, and relationships with Sponsors work best when these needs can match study processes and objectives. Participating in clinical trials can be difficult, but sites are open to collaboration and new ideas and recognize that they are part of a larger team.

Make sure you join our webinar to hear new and eye-opening insights that will help you better understand and appreciate the site perspective, and ultimately contribute to improving study outcomes.  

JOIN US TO LEARN ABOUT:
  • The gap between your study protocol and my clinical practice reality
  • What is good (or bad) about operational practices during the pandemic
  • Examples of poor study processes - and how to avoid them yourself

HELENA ROCHA, MSc., Study Coordinator,
Instituto Português de Oncologia do Porto

ERIN SILVERMAN, Ph.D. CCC-SLP, CCRC, Research Coordinator and Adjunct Assistant Professor,
University of Florida

ON DEMAND

ClinOps Perspective — So, Oversight When You Can't Visit Sites, Eh?

So, Clinical Operations when you can't actually visit your sites! As if running international GCP trials wasn't complex enough suddenly we can't visit sites like we are used to.

Learn about how to still fulfill your common GCP obligations during a global pandemic:

  • Tips from the field on how to bring these obligations under control
  • Why generating evidence of Oversight shouldn't break you
  • Benefits of a living TMF
  • Dangers of leaving the eTMF to your CRO or a separate team
  • Oversight during the COVID-19 outbreak
  • Monitoring with an inspection in mind

COLLEEN PELLEGRINI, Senior Clinical Operation Consultant, Clinical Leader
for Rare Genetic Disease Study

JENNIFER GROVE, Senior Clinical Operations Consultant, Country Manager
for UK Cardiology Study

Inspection Perspective — Tales From a Recent FDA Inspection

The expectations of regulatory inspectors are rising over time - requirements are getting tighter and sponsors are expected to make better use of their systems and data. Our speaker has very relevant experience from hosting an FDA inspection (2019) where this reality was clearly illustrated.

Learn about:

  • How this sponsor overcame a rough monitoring and documentation situation.
  • What inspectors are seeking about Oversight evidence
  • Their thoughts on the processes and systems used for the Trial Master File and the Investigator Study File (ISF)
  • Practical steps you can take to protect your study / clinical asset even if things go awry
  • Why myClin played a crucial role in "documenting the story of the study" and aiding successful navigation of that inspection.
30 MINUTES + Q&A THURSDAY, SEPTEMBER 10th 5pm CEST | 4pm BST | 11am EDT | 8am PDT

LORNE CHEESEMAN, Senior Director Quality,
Various Biopharma

Follow-up Demo

30 MINUTES + Q&A
TUESDAY, SEPTEMBER 15th
5pm CEST | 4pm BST | 11am EDT | 8am PDT

ADAM WOOD, VP Business Development,
myClin

JOE KALINOSKI, Business Development Manager,
myClin