Newsletter | February 12, 2020

02.12.20 -- A New AI Collaboration Eliminates Tedious Research Reviews

  Pharmacovigilance Market Dynamics And Service Provider Benchmarking (2nd edition)

This report delves into the pharmacovigilance market and outsourcing dynamics, provider selection, provider perceptions and user experience, and provider and software performance. Sponsors can use it to understand trends in technology use for pharmacovigilance activities, how decision makers select providers, and how said providers performed. CROs, pharmacovigilance providers, and software providers can use it to learn what capabilities are important to customers looking for providers, your performance rating (and how your competitors compare), and more. Click here.

Featured Editorial
A New AI Collaboration Eliminates Tedious Research Reviews
By Ed Miseta, chief editor, Clinical Leader

In recent years, biomedical research has faced a daunting challenge. A bottleneck, caused by knowledge creation, blocks scientists and physicians from staying up to date on specific genomic advances and quickly matching patients with treatment options and clinical trials. AI could be the solution.

Industry Insights
The Critical Role Registries Play In Rare Diseases
Article | By Don Gabriel, M.D., Ph.D., and Colleen Valenzuela, United BioSource LLC (UBC)

UBC's Dr. Don Gabriel, medical oncology and scientific strategy, and Colleen Valenzuela, clinical operations, recently appeared in a trade publication speaking to the importance of registries in rare diseases.

The Future Is Here For Clinical Trials, And It Introduces New Risks
Article | By Jennifer Dennis-Wall, Ph.D., Biorasi

Mobile phone apps and wearable devices have a lot of potential to improve clinical studies. However, the rules governing them are complex, varied, and not fully developed. It is important to be vigilant and remember best practices before rushing out to jump on the latest and greatest.

Not Like Everyone Else: Unique Challenges For Small And Emerging Biopharma Companies
White Paper | By Dr. Lindsay McNair, MD, MPH, MSB, WCG

Small and emerging biopharma companies are conducting almost 50 percent of the clinical trials in the United States today. Unlike “big pharma”, small companies are usually working with lean teams, limited resources, and minimal infrastructure. In this paper, we explore some of the unique challenges for clinical development teams, and solutions that can reduce the pressure on teams and timelines.

The Journey From Production Line To Patient: Exploring The End-To-End Requirements Of A Successful Cold Chain Operation
Article | Almac Group

Read Almac’s latest article that explores the cold chain journey, from production line to patient, to learn how you can overcome challenges within your temperature-controlled supply chain. By exploring end-to-end requirements at the earliest opportunity and adjusting manufacturing strategies accordingly, safe, agile, and optimized cold chain operations can be created for your clinical trial.

ANNEX 13 Investigational Medicinal Products: Labeling Requirements Explained
White Paper | PCI Clinical Services

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 QP (qualified person) 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.

Satisfying Aggressive Timelines With A Simplified Supply Chain For Drug Delivery
Case Study | Thermo Fisher Scientific

To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternate yet efficient route.

How Do You Put Your Disease On The Agenda?
Podcast | DIA

Through the FDA’s Patient Focused Drug Development, and similar initiatives, the value of the patient voice in drug development is clear.

Digital Technology In Clinical Trials

March 30 and 31, 2020 | Boston, MA

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ISR Reports is a full-service market research company and sister company of Clinical Leader. Operating exclusively in the pharmaceutical and pharmaceutical services industry, their syndicated and custom market research capabilities enable their customers to make smarter, more informed business decisions.


Topics include: Patient recruitment, enrollment, retention barriers, study protocol design, investigator and site selection, clinical study feasibility strategies and best practices, use of CROs and specialty providers, and recruitment strategies.


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