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NEWSLETTER APRIL 2020

NEWSLETTER
APRIL 2020

CLINICAL TRIAL NEWS

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	IDDI and COVID-19 – A Message from Damien Tremolet, IDDI CEO As a result of the outbreak of COVID-19, IDDI has implemented strict measures to preserve the health and safety of our employees and their families. In consistency with our Business Continuity Plan, IDDI has moved to work primarily from home since March 16th, 2020. We do not anticipate any direct impact on projects or timelines. IDDI’s commitment to its clients remains unaffected during this challenging time. Our management team is constantly monitoring the situation and is available to answer any question you might have.
	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 27^th 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. Data Driven eTMF and Clinical Data Management – An Integrated Approach Validating Surrogate Endpoints in Oncology: From Theory to Practice! Bayesian Outcome-Adaptive Designs: A promise not without Peril Expansion Cohorts in Early Development of Anticancer Agents Assessing Treatment Benefit in Immuno-Oncology A New Statistical Method: Generalized Pairwise Comparisons Treatment Allocations in Randomized Trials: Challenges and Best Practices 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 Design – Randomization – Data Management and Biostatistics services for Pharmaceutical and Biotech companies.