Newsletter | August 5, 2019

08.05.19 -- A Small Biotech Takes On Some Big Clinical Trial Challenges

Featured Editorial
A Small Biotech Takes On Some Big Clinical Trial Challenges
By Ed Miseta, chief editor, Clinical Leader

Evofem Biosciences is on the cusp of releasing a revolutionary birth control product. But before the FDA gives its approval, this small biopharma has to navigate two very different clinical trials.

The Human Component Of Clinical Trial Technology Implementations
By Jeffrey S. Handen, Ph.D., and Lisa Cooney, Grant Thornton LLP

As part of our ongoing series about best-in-class approaches for rapidly assessing, prototyping, and introducing digital and other clinical trial technologies, we focus our attention in this article on the “human” component of technology-enabled transformation.

Industry Insights
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.

A Strategic Partner, Or A Vendor Looking To You For The Answers?
Article | By Joy Abella, Premier Research

Any capable CRO can provide manpower and execute orders on behalf of a sponsor, no questions asked, with little stake or interest in the endeavor’s ultimate success. What you need is a strategic ally, a company that joins you, lockstep, in pursuing shared goals and greater outcomes. Not a vendor, but a partner.

When It Comes To Your Patient Adherence (Compliance) Strategy, Think Training
Article | TransPerfect

Sponsors deal with a myriad of considerations in how to reduce overall risk and costs across a study, but managing the complexity of patient behavior must always stay in focus. The challenge of patient treatment adherence and retention can do a lot more than create delays and increase expenses during a clinical trial. When a patient does not comply with the treatment regimen, the integrity of the clinical trial data is at stake, and patient safety is at risk. Read how a compliance-focused LMS can positively impact patient compliance during a clinical trial.

Real-Time Monitoring Of The Digital Patient In Clinical Trials
Poster | ICON Plc

This poster reports a framework for the real-time monitoring of subjects using wearable and patient-centric devices from multiple vendors. Wearable technology is a key component in the design of more patient-centric clinical trials.

IRT Is NOT A Commodity: Topics To Discuss With Your Vendor
White Paper | Signant Health, formerly CRF Bracket

With so many different systems available, how do you decide which one is right for your study? This paper will help you match system and vendor capabilities with the unique requirements of your trial.

  Clinical Trial Supply Southeast 2019

October 2 and 3, 2019 | Durham, NC

CTS Southeast will return to North Carolina in 2019 to look at ongoing regulations, enhancing the supply chain, and making sure the right systems are in place. Top trial sponsors and regulatory bodies, such as GSK, G1 Therapeutics, PRA Health Sciences, GS1, and many more came together to share their insights into achieving a compliant and error-free supply chain.

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