Newsletter | November 25, 2019

11.25.19 -- Janssen's Lessons Learned From Digital Health Implementation

Featured Editorial
Janssen’s Lessons Learned From Digital Health Implementation
By Ed Miseta, chief editor, Clinical Leader

In his role as product line owner for digital health at Janssen, Mark Sapp leads a team that works directly with different therapeutic areas inside the company. “Our focus is helping our clinical teams get from point A to point B,” says Sapp. “We assist them with taking their idea and scaling it up, identifying the clinical endpoints they hope to achieve, and helping them stay focused on the results they need to generate.”

Marriage Pitfalls In Strategic Partnerships — And How To Avoid Them
By Ed Miseta, chief editor, Clinical Leader

Strategic partnerships have changed dramatically in the last 20 years. Regardless of your model, one thing is certain: All of them will have their own issues and challenges. What’s important is how you choose to address those outsourcing challenges when bumps in the relationship inevitably occur.

Clinical Materials Distribution By Location

In Q32019, ISR asked outsourcers of clinical logistics about the proportion of clinical materials distributed to the following locations: trial sites, depots, warehouses, and directly to patients. The data shows the majority of clinical materials are currently sent to trial sites (53 percent) and that only 5 percent are sent directly to patients. However, over the next three years, respondents anticipate the proportion of clinical materials going directly to patients will double.

Industry Insights
Artificial Intelligence And Machine Learning/Translation In Pharma Language Translation
Article | By Mark Wade, TransPerfect

AI is being used to model, extrapolate, and automate tasks throughout the life cycle of a drug (as it should be). The potential benefits are substantial, both in terms of clinical efficacy and financial savings. With all of the supposed power and promise of this advanced technology, what are the real, practical implications for clinical outcome assessments?

An In-Depth Look: How A Unified Clinical Environment Increases Trial Performance
Article | By Ashley Davidson, Veeva Systems, Inc.

Using disparate systems to manage today’s complex clinical trials can be extremely challenging. This blog provides an in-depth look into how a unified clinical environment drives speed and higher efficiencies.

Leveraging Voice-Assistant Technology In Clinical Trials
Article | ICON Plc

Voice assistant technologies provide an opportunity to create a different level of engagement and interaction in comparison to regular apps and web pages. In addition, voice-controlled applications may remove barriers to use, particularly for those that find operation of a mobile device difficult or fiddly, or have low functional literacy.

Bringing Real-World Evidence Into Clinical Research
White Paper | United BioSource LLC (UBC)

Life sciences companies are embracing the essential roles that real-world data (RWD) and the generation of real-world evidence (RWE) play in the development of new treatments for patients. This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

An Innovative Solution To Flexibly Meet Unique Primary Packaging Requirements
Case Study | Catalent

A customer enlisted Catalent to support their child-resistant blister packaging requirements for a global Phase 3 study. A flexible design was created with an integrated blister card that could also support larger study requirements of 1.9 million monthly dosing cards. Through customized commercial blistering equipment a solution was provided that would accommodate the customer’s growing demands for clinical supplies.

Integrating Regulatory Affairs, Safety, And Clinical R&D To Manage Data And Drive Value Across The Enterprise
Webinar | Oracle Health Sciences

Regulatory affairs, safety, and clinical R&D are traditionally managed as three separate departments, each with their own business processes and software systems. As the number of these touch points increases it motivates the desire and urgency for better integration in order to operate more nimbly, reduce data discrepancies, and lower costs.

Patient Engagement Tricks And Treats
Webinar | TrialScope

Today, trial transparency and patient engagement go hand in hand. But don’t let the prospect of patient engagement scare you — join TrialScope and CISCRP for this informative webinar. You’ll discover how to obtain patient input and use it to guide your clinical trial processes and communications. And you’ll see what patients expect in terms of clinical trial engagement online — and how to deliver an improved digital experience to them.

TrialMax eCOA
Signant Health
Strategic Drug Development
Premier Research
Integrated IVD Development Services
Health Decisions Inc.
Speed To Study
PCI Clinical Services
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