Approaches to Accommodate a Wide Range of Asthma Patients

Controlling exposure often helps patients with asthma, a common condition that is often managed with self-care and inhalers.

How to run successful eFate studies for industrial chemicals

Environmental fate (eFate) studies are well established for crop protection chemicals and pharmaceuticals and are becoming commonplace for industrial chemicals, but what are the key considerations for setting up and running them?

Incorporating the patient voice to improve ulcerative colitis recruitment

The exact cause of ulcerative colitis (UC) is still unknown, but approximately 700,000 people in the United States suffer from this chronic, life-long disease that causes inflammation in the large intestine. A wide range of treatment options are available, but drug development sponsors are seeking additional ways to control inflammation, achieve remission and address relapses.

K-REACH: how to register in 12 easy steps

In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. With an estimated 44,000 chemicals in use in South Korea and about 300 new chemicals marketed annually, registrants and regulators will be kept busy assessing the risk posed to humans, animals and the environment by these chemicals. Effective Jan 1, 2019, this legislation has been revised to impose stricter controls on a broader range of substances.

Precision imaging of antibody biodistribution in vivo with Zirconium-89 PET

Zirconium-89 (89Zr) has revolutionized discovery and translation of Ab (and Ab fragment) therapeutics via PET biodistribution imaging.  With standard, straightforward labeling chemistry, 89Zr provides unprecedented specificity and sensitivity of PET Ab detection (to pM levels).  We use 89Zr PET as a platform assay for in vivo quantification of:

Labcorp delivers unmatched COVID-19 diagnostic and therapeutic applications

We’re in this together: How they are delivering unmatched acceleration of COVID-19 diagnostic and therapeutic applications

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, we have been focused more than ever on understanding the patient perspective on clinical trial participation. As social distancing has become the new normal, the need to understand changes in preferences associated with interest in trial participation should be taken into account when developing protocols.

Speeding hand disinfectant products into the EU market in response to COVID-19

The COVID-19 pandemic has increased the demand for hand disinfectants, driven by recommendations from bodies such as the WHO. Handwashing is a vital measure for reducing the risk of contracting the virus. The WHO specifically recommends that all individuals “regularly and thoroughly clean (their) hands with an alcohol-based handrub or wash them with soap and water.”

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.