Newsletter | January 11, 2021

01.11.21 -- Tread Carefully Into Virtual Clinical Trials

Featured Editorial
Industry Insights
eRegulatory Binder Checklist: What Does The FDA Require?

eRegulatory binders help clinical sites organize and digitize the regulatory process. In this post, we take a brief look at what every FDA-regulated binder needs to have.

An Advanced Design Framework For Clinical Development In The Era Of Cloud Computing

While the number of trial designs and types have gently expanded, finding the optimal trial design for a specific context remains an elusive goal. Cloud computing has altered the process of trial design by taking familiar techniques for simulation and modeling and generating thousands of different trial designs.

Synthetic Control Arm In Clinical Trials

This white paper discusses the concept of the synthetic control arm (SCA), which is a type of external control that is generated using patient-level data from patients external to the trial with the goal of improving the interpretation of uncontrolled trials, which can enable better product development decisions. A series of case studies are provided to highlight the different ways an SCA has been used.

From KOLs To Patient Advocates, Using Every Tool To Fight A Rare Disease

With a recruiting target of 18 patients for a condition that afflicts just one in 31,000 people, this CRO had to make full use of what few resources were available. By working with key opinion leaders (KOLs) and a patient advocacy group, they located their 18 patients ahead of schedule and completed the 26-week trial early.

Importing Clinical Supplies Into Japan

Rich Nelson, senior manager, global logistics, recently discussed the precision with which clinical supplies and the documents accompanying their import into Japan must be prepared. In this article he covers the commercial invoice valuation of clinical kits and clinical logistical considerations for Japan.

The Challenge Of Keeping Cool

From manufacturing through delivery to the patient, pharmaceutical drugs must be maintained within strict temperature guidelines to protect the efficacy of the product. This level of protection is not exclusive to refrigerated and frozen product. Even ambient product (generally 15°C to 25°C) needs protection in climates where it can be at risk of becoming too warm or cold.

Three Necessary Steps When Designing Your New World Protocol

A huge upswing in data volume and the number of technologies that can be leveraged to garner valuable patient insights for clinical trials is forcing the industry to rethink protocol design. Join us for a step-by-step look at how to implement new world clinical development approaches into your protocols and develop a strategy for capturing high-quality efficacy and safety data, while also facilitating compliance and optimal use of technology.


Virtual Event:
February 8, 2021, 10:00 a.m. – February 10, 2021 4:30 p.m.


Don’t miss the latest conversations in regulatory informatics, EDM, and ERS! Join your industry colleagues and regulatory thought leaders by registering for the RSIDM Forum.

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