Newsletter | January 10, 2022

01.10.22 -- Report Reflects Huge Growth Of Clinical Trials In China

Featured Editorial
Industry Insights
Quantitative Bias Analysis To Strengthen Comparative Effectiveness

In this blog learn how two sources of bias might become problematic for sponsors.

Helping Your Research Site Go Paperless

In the available article, read about the three common concerns about going paperless with clinical research.

A Primer On Cancer Immunotherapy Part 2: The Cancer Immune Response And Mechanisms Of Resistance
This article examines the rationale for combination therapies, mechanisms of resistance, and where to go from here.
How Electronic Clinical Outcome Assessment (eCOA) Can Serve Patients

Clinical trial patients face more burdens today than ever before. But carefully considered and compassionate use of technology can ease participation for patients and their families, improving study recruitment and retention.

How Real-Time Data Can Expedite Infectious Disease Clinical Trials

For infectious disease studies of any kind, the ability to accelerate trial timelines, while also providing high-quality data and reducing barriers to patient participation, is highly prized. eSource direct data capture (DDC), electronic patient reported outcomes (ePRO), and electronic clinical outcome assessment (eCOA) all help sponsors generate the data they need in real time — with less face-to-face interaction.

The Electronic Trial Master File: Study Item And Placeholder Analysis

Electronic trial master file (eTMF) systems are proving to be effective in planning, managing, monitoring, and maintaining inspection readiness and compliance. This paper explores the use of planning wizards and how placeholder creation promotes study completeness, timely document uploading, and reduced rates of quality control failures. These features can ease workloads while providing the transparency needed for inspections and audits.

Old Dog, New Tricks: How The Pharma Industry Is Innovating With Existing Technologies
Innovation in clinical technologies sometimes comes in the shape of disruptive new technologies and, at other times, as a series of incremental changes and improvements. New data are revealing positive changes, and existing tech solutions are now being used in new ways to facilitate remote engagement, analyze data, and conduct hybrid clinical trials.
Why A Centralized Data Platform Is The Key To Opening The Door For Decentralized And Hybrid Clinical Trials

The accessibility and quality of data in decentralized or hybrid clinical trials is essential across many areas of study and is vital to a study’s success. An enterprise platform promotes organization in all hybrid and fully virtual study activities. Explore how a credible system needs a few important components that provide all clinical trials with accessible, higher-quality data.

How The Global Crisis Caused By COVID-19 Is Being Addressed By Supply Chain Stakeholders

The pandemic has created significant disruption to clinical trials around the world. Thousands of trials have been suspended or have stopped enrolling new patients because of the difficulties in continuing under lockdown conditions.

The Key To Increasing Diversity In Decentralized Trials

Historically, decentralized clinical trials (DCTs) were heralded as the future of patient-centered research. But how can your organization “walk the walk” when it comes to increasing trial access to underserved populations and enrolling diverse participants?

A Better Way To Drive Your Digital Transformation

As the ways in which clinical trials are conducted and monitored continue to modernize at pace, there is an urgent need for digital transformation in the industry. If sponsors are to realize their goals of running flexible, decentralized trials, risk-based management, or adaptive trials while adopting Big Data, artificial intelligence, and machine learning, the emphasis must now be on technology solutions that optimize clinical trial data workflows by bringing the technology to the data.

Reimagining Oncology Clinical Trials With Digital Biomarkers

In this paper, look at the perceived barriers to the adoption of wearables — and the major benefits that await sponsors that overcome them.

Roche Cuts Feasibility Process By 36%

Discover the solutions to how an industry pioneer and veteran biotech struggled with complexity and consistency when it came to its approach to clinical trial feasibility.

Clinical Supply Global Optimization: Managing Complex Global Drug Distribution And Expiry

A global top-ten pharmaceutical company was sponsoring a complex, eight-year Phase 3 trial across 43 countries. The sponsor was under intense pressure to reduce trial costs and leverage internal resources. Ultimately, study sites began to run out of medication. They realized that the trial could be better managed if it was outsourced.

Benefits Of A Central Site Model

A centralized site model allows patients to be treated at one or two central sites, which minimizes the travel burden on patients and caregivers. A combination of technology and/or mobile staff are employed to conduct follow-up visits in a convenient local setting or at the participant’s home. Benefits include greater consistency and operational efficiency that is more manageable and saves costs.

Six Reasons Early-Phase Oncology Trials Fail

Learn the pitfalls that drive early-phase trials to failure and tips to prevent your own trial from floundering.

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ISR Reports is a full-service market research company and sister company of Clinical Leader. Operating exclusively in the pharmaceutical and pharmaceutical services industry, their syndicated and custom market research capabilities enable their customers to make smarter, more informed business decisions.


Topics include: Patient recruitment, enrollment, retention barriers, study protocol design, investigator and site selection, clinical study feasibility strategies and best practices, use of CROs and specialty providers, and recruitment strategies.


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