Newsletter | May 15, 2019

05.15.19 -- Building And Applying A Configurable Clinical Study Model

Featured Editorial
Building And Applying A Configurable Clinical Study Model
By Jeffrey S. Handen, Ph.D., Yesh Ajgaonkar, and Neil Conroy, Grant Thornton LLP

Last month we introduced an approach for the rapid assessment and prototyping of digital and other clinical trial technologies. Advances in technologies and digital innovations targeting the clinical research environment are evolving at dizzying rates, and the need to efficiently assess and implement opportunities is greater than ever.

Industry Insights
Pharma’s Digital Awakening: Research-Ready Health Information And AI To Reduce Cost And Deliver Better Treatments
White Paper | By Florian A. Quarré, Ciox Health - Life Sciences

Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and ultimately improve customer satisfaction.

More Than A Resource For Rare Disease
Article | By Justin Gambill, United BioSource LLC (UBC)

United Biosource’s manager of program management has visited many premier medical facilities in the nation treating some of the most-rare childhood diseases during his career. He shares a few things he believes we all can do to positively impact the lives of people living with rare diseases as a result of these experiences.

Clinical Labeling: Looking Ahead
Article | TransPerfect

As we enter the 2019 labeling landscape — with changing regulations and slashed submission timelines — producing labels with 100 percent accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.

Patient Recruitment Solution
Article | Biorasi

Understand the role of a study navigator and how they help to ease patient worries and up the odds they’ll enroll — and stay enrolled — in your study.

Innovative, Flexible, And Time-Sensitive Packaging Solutions
Case Study | Thermo Fisher Scientific

Given the rapidly changing landscape of today's trials, if sponsors wish to succeed, they must remain vigilant — attending to every detail of the process. Learn more about how several sponsors achieved success through these case study examples.

Recruiting Hard-To-Find Patients From A Specific HLA Subgroup
Case Study | Premier Research

A CRO helps a company overcome an early patient screening failure rate of 70 percent as well as assists with instituting new protocols and renegotiating contracts as the study experiences a major change of direction.

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 CMC (chemistry, manufacturing, and controls) development.


Join the expert speaking faculty of over 30 life sciences, healthcare, and tech professionals on June 13 and 14, 2019, in Philadelphia, as we elevate clinical trial operations, healthcare outcomes, and supply chain implementation through AI. Use Discount Code LSC to save 15% off the standard registration rate.

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