Patient Intelligence: designing clinical trials in the COVID-19 era

In the age of COVID-19, patients can’t wait for new vaccines and therapies to come to the market. That is why even in these challenging times, Covance has been focused more than ever on understanding the patient perspective on clinical trial participation. As social distancing has become the new normal, …

Addressing the challenges of data management for pharmaceutical and biotechnology companies: introducing Laboratory FSPx

Data currency management for clinical trial laboratory results can be a point of frustration for today’s pharmaceutical and biotechnology companies. Whether data is coming from a contract research organization (CRO), a central laboratory or third-party laboratories, fulfilling the need for timely availability of clean data based on unique sponsor format/industry …

Expediting SEND datasets for an international regulatory submission

A case study with Peg Biomedical Co., Ltd Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.   While business between Peg Bio and Covance first started in 2014, the strength and …

Fixing the patient recruitment “leaky funnel”: blending data with a patient and site-centric approach to address the challenge

Most people in our industry are familiar with the “Leaky Funnel” analogy that describes the model where we approach a large number of patients for inclusion in a study, but they leak out of the pipe at every juncture. The loss of patients through planning, screening and execution of the …

What’s changing in SEND 3.1?

The SEND [Standard for Exchange of Nonclinical Data] Implementation Guide v3.1, “SEND 3.1,” changes the model for the reporting of cardiovascular and respiratory endpoints. SEND 3.1 became effective 15 March 2019 for NDA/BLA submissions; and it will become effective 15 March 2020 for IND submissions, overlapping with the effective period of the previous version, …

Empowering CRAs with mobile tech to improve site quality through monitoring efficiency

Clinical research associates (CRAs) need immediate access to relevant and accurate site performance metrics, but information is often isolated within multiple databases and spread across different tracking systems. To deliver key site performance data to CRAs via mobile and web applications – quickly and conveniently – Covance has created a …

Achieving Compliance with E6: Exploring the Workflow Challenges

Most sponsors are well aware of the recent revision (R2) of ICH GCP E6, which outlines recommendations to unify standards across the EU, Japan and the U.S. with defined requirements for sponsors regarding the role of monitoring and risk management, there are many factors to consider for a successful implementation. …