Newsletter | October 16, 2019

10.16.19 -- Regeneron Manages Clinical Costs In A Fast-Growing Organization

  IRB Performance And Best Practices In Site Start-Up

ISR is hosting a webinar on October 29 at 12:00 PM EST to review findings from two recent pieces of market research — one on IRB performance across metrics such as timeliness and responsiveness of protocol review and local IRB/regulatory knowledge, and the other is an in-depth look into what CROs and sponsors are doing, what’s working, what’s not working, and what’s next in their quest to increase the efficiency and effectiveness of site start-up activities. Click here to register.

Featured Editorial
Regeneron Manages Clinical Costs In A Fast-Growing Organization
By Ed Miseta, chief editor, Clinical Leader

More complex oncology and rare disease trials are leading to a rise in the number of patients, sites, and clinical trial endpoints. All of that adds to an already challenging environment for biopharma companies struggling to understand where costs are increasing and what can be done to control them.

What Issues Should Be Part Of Your Outsourcing Decision?

In May 2019 Clinical Leader Live was proud to feature Laurie Halloran, president and CEO of Halloran Consulting Group. Ms. Halloran presented on the topic of “In-House vs. Outsource: Decision-Making Considerations.” During the presentation she covered balancing growth with your outsourcing needs, the organization maturity model, the transformation of the clinical operating model, the trends in CRO outsourcing, and determining what outsourcing model is best for you. In this video, Halloran discusses what issues should be part of your outsourcing decision.

Industry Insights
How Virtual Are You Willing To Go?
Article | By Jessica Perry, IQVIA Virtual Trials

Virtual trials promise to disrupt the clinical research environment, allowing patients to participate in trials from their homes using wearables, telemedicine, and treatments shipped right to their door. Following are three ways to adapt the virtual trial model to your unique research needs.

Addressing Translation And Approval Challenges Within The Clinical Trial Labeling Process
Case Study | Thermo Fisher Scientific

A major global pharmaceutical sponsor was seeking a new approach to enhance the efficiency of their supply chain process including their label and translation management approaches.

Why User Experience Is Essential To Success With EDC
Case Study | Medrio

A busy and diversified sponsor organization required a data management solution flexible enough to meet the unique requirements of each therapeutic area of study.

Large PMA Study Of CRC Diagnostic
Case Study | Health Decisions Inc.

A study needed to enroll approximately 12,000 subjects and was also unique because it required subjects to self-collect samples at home. Read about the risk management and mitigation that Health Decisions utilized to keep the study on track.

AstraZeneca Takes An Innovative Approach To Trial Results Summaries
Case Study | TrialScope

AstraZeneca made a commitment in 2015 to deliver PLS in advance of the European Medicines Agency (EMA) policy coming into play, says Julie Holtzople, clinical trial transparency operations director. Many other sponsors have followed suit, taking a proactive approach to clinical trial disclosure and transparency. The statistics explain why.

Clinical Trial Diversity Begins (And Ends) With Patients First
Podcast | DIA

Conversations about disparate healthcare access often address therapies approved for market, but how can we ensure equity in the clinical R&D processes that generate these therapies? 

Ensuring Safety And Multivigilance Compliance Across The Product Life Cycle
Webinar | Oracle Health Sciences

The regulatory landscape for safety has changed dramatically over the last four years and shows no signs of slowing down any time soon. This webcast provides an update of the current situation worldwide, a preview of what the next few years will bring, and a solution using Oracle Safety Cloud to remain compliant through it all. 

Real World Evidence
United BioSource LLC (UBC)
myTI: Mobile eTMF
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