Newsletter | March 23, 2020

03.23.20 -- Clinical Operations In The Age Of A Pandemic


What characteristics and skills can you develop to improve communication channels with your CROs and sites? Join Clinical Leader Live on Tuesday April 7, 2020, for a virtual conference examining how your style, approach, and active listening skills can help alleviate the communication breakdown and, in turn, improve trial quality. Register.

Featured Editorial
Clinical Operations In The Age Of A Pandemic
By Len Rosenberg, Ph.D., R.Ph., Leukemia & Lymphoma Society/Beat AML Master Trial
The Beat AML (BAML) master clinical trial was focused on efficiency and speed of operations, not on the coronavirus outbreak or pandemics in general. Yet, the model and technologies used by BAML are applicable for biopharma sponsors who want to adapt their clinical operations to support remote monitoring and faster acquisition of data while preparing for another outbreak or weathering the current crisis.
Improving Serious Adverse Event (SAE) Reporting In Clinical Trials
By Karen Outten, Merck

Throughout the pharmaceutical industry, patient safety data collected during interventional clinical trials can vary widely across trial sponsors. While sponsors are required to follow the same health authority reporting regulations, there is a lack of standardization across the data fields included on serious adverse event (SAE) case report forms and SAE paper reporting forms.

Industry Insights
From Psoriasis To Behçet’s: The Evolution Of Biologics In Dermatology
White Paper | By Marlis Sarkany, Premier Research

There is a clear shift in dermatology drug development toward biologics, targeted treatments, and rare skin diseases and away from topicals and symptomatic treatments. Learn more about the number of indications that are in development.

Service Excellence: The Cornerstone Of Quality Clinical Trials
Article | By Chris Flint, Cenduit LLC

Sponsors and CROs are not getting adequate eClinical technology service and support. This is especially true in the case of some providers who seem to have tacked IRT systems onto eClinical suites, almost as a checkmark, without forethought toward designing for change or potential protocol amendments along the trial’s life cycle. You need a solution with not only a technology that works, but also a team available that supports them every step of the way.

Learnings On “Bring-Your-Own-Device” Uptake For eCOA Implementation
Poster | By Kieran Carroll, Brad Sanderson, Bill Byrom, Antti Heikkilä, Jill Platko, Ethan Barnes, Jessica Turnbull, Raymond Fatto, and Rauha Tulkki-Wilke, Signant Health

In this poster we cover research designed to understand site and subject behavior toward the use of “bring-your-own-device” (BYOD) and provisioned handsets, including usage and access behavior, with reference to two large clinical trials.

Quality Metrics: How To Add Value And Meet The FDA's Expectations
Article | Ropack Pharma Solutions

Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. 

Braving The Complexities Of Immuno-Oncology Trials
White Paper | LabConnect

Immuno-oncology trials are increasing in prevalence and, for many reasons, are much more complex than standard clinical trials. Learn how partnering with an experienced central lab can alleviate these challenges, create efficiencies, and save researchers time and expense.

Top 5 Selection Attributes Gaining Importance For Outsourced Bioanalytical Lab Services
Infographic | ISR Reports

In Q32019, ISR asked outsourcers of bioanalytical lab services about their thoughts on 22 selection qualities that have become more important in the past year when choosing a provider for bioanalytical lab services. Assay Development Expertise (46 percent), and Technical Expertise/Experts (44 percent) top the list of lab qualities that are increasing in importance.

Development Advice For Gene Therapy Products
Webinar | Rho

This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and chemistry, manufacturing, and controls (CMC) development.

  Impact Of COVID-19 On Clinical Trials

Wednesday, March 25, 2020 | 11:00 AM EDT

Registration is open for this free ClinBiz Virtual event on the Impact of COVID-19 on clinical trials. The event will have industry leaders from both pharma/biotech study sponsors, investigator sites, and industry expert consultants as part of a great panel discussion on the COVID-19 impact on clinical trials and what different organizations are doing to ensure clinical trial continuity.

Life Science Training Courses
FDA REMS Inspection Guide: Audit Preparedness Best Practices

March 25, 2020 | 1:00 PM EDT

Medical Device Recalls: Keys To Implementing A Successful Approach

April 14, 2020 | 1:00 PM EDT

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