Newsletter | May 18, 2020

05.18.20 -- Adjusting To Clinical Trial Remote Monitoring During COVID-19: Working Smarter & Safer

 
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The Golden Retriever Lifetime Study: 5 Years Of Progress In Veterinary Health And Biobanking

An overview of a prospective cohort study of some 3,000 young Golden Retrievers, and how extensive data and biological samples will be used for future analyses of major diseases, disorders, or conditions.

How Calibrated Are Your Trial Measurement Tools?

Every person participating in a clinical trial creates inherent variability in the way they perform. A patient’s ability to report their symptoms accurately will impact trial data, as will a site staff’s verbal and nonverbal communication cues. But what if you could train people to reduce measurement error — and even decrease the placebo response? Read the article to find out how.

Study Activation: A Complex Process That Doesn’t Have To Be Painful

Long activation timelines are a familiar concept in the clinical trial landscape. How can your site improve its study activation timelines?

Five Frequently Asked Questions (And Answers) About eConsent During The COVID-19 Crisis

For the clinical research industry, COVID-19 poses immediate and longer-term challenges. Sharing experiences is vital to our industry, now more than ever. Here I share the most frequently asked questions about eConsent technology, along with our responses, since ithey may be of value to your organization at this time.

Immunogenicity Assessment: As FDA Guidance Shifts, How Can You Reduce Clinical Hold Risks?

Biotechnology entrepreneurs face many challenges as they push to bring potential new drugs into the clinic, whether that means raising the necessary funds for a clinical trial or conducting adequate assessments that ensure drug safety and efficacy. One main concern is often challenging: keeping up with ever-evolving regulatory guidance.

ANNEX 13 Investigational Medicinal Products: Labeling Requirements Explained

Can you imagine working for months to ensure your clinical supply strategy is in place for your European studies, only to have them be delayed because labeling requirements were out of compliance and the qualified person (QP) or the site(s) rejected the materials you wanted to use in a trial? The purpose of this guide is to walk U.S.-based clinical supply professionals through the labeling requirements laid out in Annex 13 of the EU GMP guidelines.

COVID-19 Guidance For eCOA From The Critical Path Institute ePRO And PRO Consortiums

COVID-19 has forced a reckoning in how we conduct all aspects of our lives, and clinical trials are no exception. The Critical Path Institute ePRO and PRO Consortiums — precompetitive, collaborative groups of eCOA providers and sponsors who work together to advance the science of electronic data capture — recently released a joint assessment and guidance for those using eCOA in clinical trials.

Keeping A Focus On Rare Disease

The last day of February is always Rare Disease Day, the biggest day of the year for the rare disease community. Read some highlights from this year's event attended by researchers, physicians, regulators, and patient advocates.

U.S. Clinical Labels 101: Steps To Ensure Accuracy

Determining a drug candidate’s probability of commercial success is a most significant phase in the drug development process. There is no room for error.

Infectious Disease Teams

A not-for-profit sponsor requested assistance with monitoring in an Ebola hot spot at trial naïve sites with little experience. Ultimately, the study required rapidly deploying solutions across diverse geographies. Read how the quick response and the geographic alignment of the team enabled the study to be completed.

Clinical Ink And CRO Partner To Create A Disease-Specific Solution To Facilitate Lupus Clinical Trials

For sponsors and CROs, clinical trials for systemic lupus erythematosus (SLE or, more commonly, lupus) present a specific set of challenges that can impact the recruitment of investigators and patients and inhibit the ability to collect accurate data. This white paper discusses the challenges of diagnosing lupus, the unique difficulties lupus clinical trials face, and how the innovative eLAS platform helps meet these challenges.

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