Are your CERs ready for MDR?

Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex.

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

This two-part blog serves to summarize the 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 our Medical Device and Diagnostic Solutions through a review of the GDPR itself and publicly available resources on current interpretations of GDPR compliance. The Medical Device and Diagnostic Solutions recommends that sponsors obtain legal counsel on this important topic.

The simple steps to successful active substance renewal in the EU

In the EU, the renewal procedure for existing plant protection active substances (under the “AIR” program) requires advance planning and careful management to comply with ever-evolving regulatory requirements. Read below for practical advice on how to prepare your renewal applications and discover how Labcorp can support you.

Advancing the next generation of pluripotent and multipotent stem cell candidates

Cell therapy breakthroughs, such as chimeric antigen receptor T-cell (CAR-T) therapy, have made a significant impact on the oncology landscape, but many potential breakthrough cell-based therapies are emerging in other therapeutic areas, such as neurodegenerative diseases and macular degeneration.

Building efficiencies into decentralized long-term follow-up studies

As part of an ongoing effort to improve efficiencies and increase patient centricity, long-term follow up (LTFU) studies are increasingly using decentralized clinical trial (DCT) models and reducing the need for patients to visit physical investigator sites.

Immunogenicity studies for the coronavirus vaccines: How to stay on track and build testing capacity even during COVID-19

As the world waits for a vaccine to protect against COVID-19, the disease caused by the novel coronavirus, it will need not only scientific excellence but also business continuity excellence to keep vital research and immunogenicity studies running.

In vitro drug-drug interaction (DDI) regulation updates in the FDA’s 2020 guidance: A summary

In January 2020 the Food and Drug Administration (FDA) reviewed its 2017 draft content and published finalized guidance for in vitro and clinical drug interaction studies. We’ve summarized the the key changes and implications for in vitro drug-drug interactions (DDI) testing in this post, but if you would like more detail on specific changes, review our in-depth online whitepaper, comparing FDA, EMA and PMDA DDI regulations.

IND-Enabling programs for adoptive cell therapies

We presented on and discussed in a webinar the adoptive cell therapy preclinical program central to an IND/IMPD submission. The following is a brief summary, plus insightful Q&As from that event.

The COVID-19 road to recovery: coordinating clinical trial testing and central lab solutions

As COVID-19 was declared a pandemic, our Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs.

Clinical oversight during the COVID-19 pandemic: 5 reporting lessons learned

Clinical trial sponsors need the ability to monitor the health of their study or portfolio of studies on an ongoing basis.  In times of crises, this becomes a challenging task, as the rapidly evolving situation might render standard reporting tools inadequate and outdated. The Xcellerate® technology suite has been developed with the goal of accommodating the diverse reporting needs of sponsors that run trials with us, but the COVID-19 pandemic has been a unique situation.