Cell Therapy

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. “What we see in the cell-based therapeutic research area today represents …

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 …

pharmacovigilance

Transforming pharmacovigilance operations through automation and cognitive technologies

Traditionally the pharmacovigilance (PV) function has been responsible for collecting, assessing and reporting adverse events (AEs) and related drug safety information to regulators. Because PV is so process driven, companies have had to invest in safety systems to organize data and optimize efficiency. Yet these closed systems, including home-grown systems, …

Patient Centricity

Inflammatory Bowel Disease clinical studies and the importance of patient centricity

In today’s exceptionally crowded clinical trial environment of inflammatory bowel disease (IBD), patient-centric practices can help your study of Crohn’s disease (CD) or ulcerative colitis (UC) stand out to both patients and sites. Learn about your options to increase your trial’s patient centricity, encourage recruitment and promote ongoing patient retention. …

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 …