Purple DNA Strand

Immuno-Oncology Studies: Optimizing Design, Recruitment and Execution

The rise of immunotherapy has been meteoric — there are now well more than 1,000 immuno-oncology (IO) trials ongoing according to clinicaltrials.gov. Finding and enrolling the appropriate patients for these potentially revolutionary treatments has presented a profound challenge, one that was recently covered in the aptly titled New York Times …

Can We Expand Companion Diagnostics Beyond Oncology?

The majority of today’s approved companion (and complementary) diagnostics (CDx) support personalized medicine efforts in oncology, a testament to researchers’ growing knowledge regarding the genetic pathways impacted in various cancers. That understanding increases our ability to convert such knowledge of biology into treatments that specifically target disease based on a …

Covance Central Laboratory Services in Shanghai Helps Clients Navigate Chinese Regulatory Reform

Following the rebrand and restructure of the Chinese regulatory body, the China Food and Drug Administration (CFDA), in 2013, the regulation process now includes inspections for all multi-national and local pharmaceutical companies with drug filings in China. As a continued commitment to meet clients’ needs and conform to local Chinese …

ELISPOT Assay: A Powerful Tool in Vaccine Development and Immune Monitoring

Over the past several years, the scientific community has made tremendous progress in advancing our understanding of the immune system, from the basic functions of its various components to molecular pathways that operate within those components. With new, state-of-the-art tools and technologies, immunologists now have the ability to better understand the …

TQT Waivers: One Year Later

Overcoming Design Challenges ICH E14 REGULATORY GUIDANCE 2005 AND 2015 It has been one year since the International Conference on Harmonisation (ICH) updated its 2005 cardiac safety guidelines. The 2015 update allows for specific QT interval analysis based upon concentration effect modeling up to supratherapeutic during Phase I as a …

Kits & Logistics for Vaccine Studies

Behind the Scenes with Kits & Logistics for Vaccine Studies

Whether large or small, vaccine studies differ from standard drug development in many ways. Sarah Slette, Sr. Study Manager, Vaccines & Novel Immunotherapeutics at Covance, explains the unique challenges her team faces and their solutions to rapidly deliver customized vaccine kits to sponsors’ sites across the globe.

Covance Mobile Health Blog

Developing a Successful Regulatory Strategy for Mobile Health Devices and Applications

For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The guidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas. To make progress in this rapidly changing field, …