NEWSLETTER APRIL 2020

NEWSLETTER
August 2020

CLINICAL TRIAL NEWS

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WEBINAR: COMPANION DIAGNOSTICS AND CLINICAL DEVELOPMENT IN ONCOLOGY: A STATISTICAL PERSPECTIVE
September 17, 2020: 11am EDT – 5:00 pm CET
This webinar will provide a discussion around the need for integration of biomarker and IVD validation in clinical development, with a focus in oncology and companion diagnostics. It will highlight how flawed analytical and/or clinical validation can jeopardize a biomarker’s and drug’s clinical utility and showcase why biomarkers deserve statistical rigor throughout the development and validation process. More info
 
PRESENTATION: Integration of biomarker validation in clinical development a statistical perspective

As statistical experts in validating IVDs based on single biomarkers and biomarkers panels, IDDI has presented on Biomarker validation at 5th Annual Biomarker and Companion Diagnostics Conference in San Diego.
Learn on

  • ‘Fit-for-purpose’ analytical validation
  • Clinical validation of (companion) diagnostics
  • Bridging for (follow-on) companion diagnostics

READ PRESENTATION HERE 

 

FDA and EMA Release Guidance on Conduct of Clinical Trials during Covid-19 Pandemic

On March 27th 2020, the FDA issued an updated ‘Guidance for Industry, Investigators, and Institutional Review Boards’ on ‘Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Similarly the EMA issues a Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

Please CLICK HERE if you want to discuss with IDDI experts whether these measures impact your trial and how to put in place a mitigation plan.

WE KEEP ON HIRING!

Tremendous opportunities in Belgium and in the US. Apply today!

VIEW OUR CAREER PAGE 

BUSINESS CONTINUES – Just tons more TCs than ever before!

Working great with our colleagues (consultants & Bus Ops) to deliver for our clients in these challenging times!

– Erik Falvey, Senior Director, Business Development Europe, erik.falvey@iddi.signalsuite.com

– Vicky Martin, Senior Director, US Business Development, vicky.martin@iddi.signalsuite.com

– Robert Whitaker, Director, Business Development, West Coast USA, robert.whitaker@iddi.signalsuite.com

CONTACT US 

WEBINARS & PRESENTATIONS

In this disruptive time, stay safe and take the opportunity to discover our complimentary expert webinars.

VIEW MORE ON-DEMAND WEBINARS 

COMBINING PASSION, SCIENCE AND EXPERIENCE
TO ENSURE YOUR CLINICAL DATA IS READY FOR SUBMISSION
 
IDDI is a biostatistical and eClinical services provider offering Trial DesignRandomizationData Management and Biostatistics services for Pharmaceutical and Biotech companies.