Newsletter | June 26, 2019

06.26.19 -- What The Patient Voice Taught Lilly About Clinical Trial Design & Recruitment

Focus On Patients
What The Patient Voice Taught Lilly About Clinical Trial Design And Recruitment
By Joseph Kim, senior advisor, clinical operations and digital registry, Eli Lilly and Company

When you’re diagnosed with cancer, diabetes, an autoimmune disorder, chronic pain, a neurological condition such as Alzheimer’s disease, or another illness, having the safest, most effective medicine is paramount. Knowing a promising therapy is “in the pipeline” doesn’t bring you a whole lot of comfort. You want access to the most advanced medicines now.

Adopting eConsent To Better Patient Experience In Clinical Trials
By T.J. Sharpe, cancer blogger, survivor, and advocate

Electronic consent to clinical research — “eConsent” — is a hot topic within the clinical research world as more sponsors and sites explore what solutions are available and appropriate for them. Yet many clinical trials are stuck in paper-based consent, either underutilizing the technology tools at their disposal or not using them at all. Understanding the reasons for a transition to eConsent and the hesitancies to make these changes gives insight into one of the last bastions of the clinical research industry to embrace the digital revolution.

Industry Insights
Don’t Let Insufficient Data Undermine Your CMO And CRO Selection Processes
Article | By Kevin Olson, ISR Reports

Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision. 

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.

EudraVigilance Survival Guide
Article | United BioSource LLC (UBC)

What it is, why it is important, and what sponsors need to think about as it gets closer.

Caregivers: The Missing Link To Patient-Centricity
White Paper | Syneos Health

Caregivers are an integral part of the care team and are involved in everything from medication choice to adherence strategy. Yet, they’ve often been an afterthought for life sciences companies, even as the industry focuses on patient-centricity.

Managing Risks To Time Critical Product Imports At Clinical Supply Depots
Case Study | Catalent

This case study outlines the steps that Catalent took to ensure the QP release process could quickly advance in Israel while simultaneously updating the warning labels to meet the QP requirements.

Unrivaled Data. Deeper Insights.
Infographic | Covance

Patient recruitment has long been considered and continues to be a major pain point in clinical trials, accounting for roughly 40 percent of the time and cost for study completion. Covance can impact protocol design and feasibility, optimal site selection, and patient recruitment by combining our four unique data sets with our therapeutic and functional expertise to deliver studies up to 4.9 months faster than the industry.

Moving Beyond Regulatory And Performance Metrics In Starting Clinical Trials
Webinar | Oracle Health Sciences

How sponsors/CROs are looking for ways to incorporate business intelligence (BI) into the eClinical systems they are using to empower oversight — turning raw trail data into actionable information.

Getting The Most Out Of Interactive Response Technology In Clinical Trial Supply
Webinar | Sharp Clinical Services

This webinar highlights how, through better planning and early engagement with experienced IRT specialists, you can reduce the risk, time, and resources spent on your clinical trial.

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