CRO Meeting

Working with a CRO – tips from the sponsor’s perspective

Congratulations! You’ve just selected the contract research organization (CRO) that best fits your goals, timeline, budget and philosophy. You’re confident that the project team, study and company will be successful! What’s next? Whether you are expecting a “turn-key” solution from your chosen CRO or are partnering with them for a …

EU MDR and IVDR implementation and deadlines – Proposal for EU MDR application delay

The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on 25 May 2017 replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD). As indicated in the regulations, from the date the regulations entered into force, …

GDPR_V1

GDPR: What is it and what does it mean for your clinical studies: Part II

This two-part blog serves to summarize Covance Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors.  It does not serve as legal advice; it is a summary of information gleaned by Covance Medical Device and Diagnostic Solutions through a review of the …

GDPR_V1

GDPR: What is it and what does it mean for your clinical studies: Part I

This two-part blog serves to summarize Covance Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by Covance Medical Device and Diagnostic Solutions through a review of the …

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Covance and LabCorp deliver unmatched COVID-19 diagnostic and therapeutic applications

We’re in this together: How Covance and LabCorp are delivering unmatched acceleration of COVID-19 diagnostic and therapeutic applications Accelerating much needed COVID-19 testing, vaccines and treatment options across the world can’t be done alone. We’re in this together and ready to apply our unique combination of solutions that blend Covance …

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ISO 14155 update: key risk management changes for medical device clinical investigations in 2019

The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year. According to the International Organization for Standards (ISO), the updated edition will focus on …

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How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies

How could a no-deal Brexit affect my medical device lifecycle? Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario. The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical …