Newsletter | July 10, 2019

07.10.19 -- The Cell Therapy Discovery About To Disrupt Clinical Trials

  CRO Quality Benchmarking: Phase 2 And 3 Service Providers (11th Edition)

This market research report has been designed to give readers an educated approach to service provider selection and includes informed analysis of provider performance. Sponsors can use it to learn which service providers best suit their needs, and service providers can use it to learn how their performance compares to their competitors in Phase 2/3 research and related services. Click here to read more.

Featured Editorial
The Cell Therapy Discovery About To Disrupt Clinical Trials
By Ed Miseta, chief editor, Clinical Leader

While pursuing his Ph.D. in chemical engineering at MIT, Armon Sharei developed an interest in novel cell therapies. That interest led him to a discovery that today is the foundation of SQZ Biotech, a cell therapy company where he serves as CEO. Sharei discovered a new method of inserting materials into cells more effectively than anything that currently existed.

A Prepared Approach To Technology In Clinical Trials
By Alishah Chator, Johns Hopkins University, and Kinari Shah, DIA

Advancements in technology create new avenues for optimizing clinical trials and the lessons that can be learned from them. With the gap between advancements in technology and regulatory uptake in clinical trials, it is important to rigorously examine technology applications. While the promise of new technology can lead to overenthusiastic adoption, mirroring the pace of other industries may not always lead to the best outcomes for patients. To increase regulatory buy-in to the use of these technologies, the clinical trial world needs a thorough understanding of the functionalities of each technical innovation, its potential utility and limitations, and how to build trust among patients, regulators, and other healthcare professionals.

Industry Insights
The Importance Of Proactive Clinical Returns Planning
Article | A Q&A with Dianne Coughlan and Rognvald Lamb, Catalent

Help sponsors design a more holistic strategy to managing the clinical supply returns process.

Assuring Outsourcing Obligations With Specialist Data Management Oversight
Article | By Alla Muchnik, Cytel

This blog discusses how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies who may lack their own internal oversight resources.

The Importance Of Real World Evidence In Oncology
Article | By Alastair Macdonald and Noolie Gregory, Syneos Health

There is a significant need to collect real-world evidence (RWE) to demonstrate the benefit of drugs in clinical practice, which can then be used as the wraparound to demonstrate true clinical benefit and address all stakeholder needs.

Data Governance In The Clinical Trial Ecosystem
White Paper | By Jaime Cook, YPrime

For biopharmaceutical sponsors, clinical trial data is both the greatest organizational asset and the greatest challenge. This paper discusses the principles of data governance and how they are used to build a business intelligence framework that advances data quality, acquisition, and integration to deliver actionable information for use across the drug development enterprise.

Customized Labeling Solution Delivers Seamless Trial
Case Study | Almac Group

Clinical labeling is a function that has the potential to make or break a study, depending upon design and execution. A function that was once seemingly on the periphery of clinical trial management has now taken on a new level of significance with increasingly complex labeling requirements. This case study highlights the complexities involved in label design and execution and how Almac worked with one sponsor to identify and rectify a flawed design to ensure a seamless trial, an improved patient experience, and enhanced overall trial performance.

Monitoring Clinical Trials With Electronic Informed Consent
Webinar | Signant Health, formerly CRF Bracket

During this webinar, informed consent experts with decades of hands-on monitoring experience discuss the challenges they’ve encountered and how to overcome them with the integration of eConsent.

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