Newsletter | July 19, 2021

07.19.21 -- Merck's Efforts To Increase Patient Diversity

 
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Innovation Is Really, Really Hard: Here’s How You Make It Happen

Only 5% of available medical data is available and usable to researchers. Imagine how quickly medical research and healthcare practice could advance if, with a little innovation, we had access to all of the data? Real innovation takes real hard work — it's not a product of solitary genius.

Redefining Clinical Strategy With Scenario Planning

Key assumptions are made at the outset of setting up a clinical trial surrounding country and site selection. What if those assumptions shift? Do you know with a certain level of confidence how changes in those assumptions will impact the execution of the study? This is why scenario planning is so valuable and critical to help manage the variability in clinical trial setup decisions.

Choose The Right FDA Program To Expedite Your Rare Oncology Trial

With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment options, researchers, clinicians, and patients may be seeking approaches to accelerate the development and approval of novel therapies. In this blog post, we review the regulatory programs available to expedite treatments for rare disorders and serious diseases.

Long-Term Follow-Up Studies Go Virtual

Long-term follow-up studies can be expensive and time-consuming for investigators, sponsors, and patients. Read how virtual models can improve patient retention in long-term follow-up studies, cutting the time, cost, and burden for patients and investigators.

Solving The Problem Of Dynamic Fields In Case Record Forms (CRFs)

The use of hide/show logic in electronic data capture (EDC) systems is not a new concept. However, traditional EDC solutions deliver this hide/show logic in ways that pose challenges to the site and consequently impact data quality. Learn how progressive display in a modern EDC system eliminates unnecessary edit checks and makes data entry more intuitive for sites.

Mitigating Inherent Risks In Global Sample Processing
The global demand for specialized sample processing has grown dramatically. However, despite the rising need, research teams continue to struggle to obtain high-quality laboratory support services to perform sample processing. Learn how innovative flow cytometry’s fast turnaround and monitored, specialized processing can help safeguard samples.
COVID-19 Vaccine Clinical Trials In Children: Challenges On The Horizon

Vaccine clinical trials against COVID-19 in adults are leading the effort before studies begin in children. Adapting the accelerated activities in the adult vaccine programs to children will be inherently difficult as clinical trials will be needed to establish safety and efficacy. However, this goal is achievable with strategic, early planning to ensure ethical trial conduct.

Industry Survey On Implementation Of ICH E17 Guidelines

How does industry perceive the impact of the ICH E17 Multi-Regional Clinical Trial (MRCT) guideline in some key international countries? Are the guideline recommendations fully utilized, and how are regulatory authorities being perceived in implementing them? In this article we review how promoting awareness of ICH E17 training materials, which are not widely used, widens understanding of the guideline beyond clinical trials.

Blood Disorder Clinical Trials: Adapting To COVID-19 Challenges

The spread of COVID-19 has heightened the potential risk of infection for patients suffering from blood disorders. Hematologist Dr. Robert S. Negrin, a new member of Biorasi’s growing Scientific Advisory Board, weighs in on understanding and adapting to changes to blood disorder trials and treatment during the pandemic.

What Are Decentralized Trials And Why Do They Matter So Much Today?

The aim of decentralized trials is to encourage patient participation by reducing or eliminating the need for travel to sites. These trials are conducted remotely, with subjects needing far less, or no, time at the traditional clinic or hospital. This is only possible through the advancement of technology, driving an increasingly mobile user landscape than ever before.

Tekton Research Experiences A 'No Findings' FDA Inspection

As COVID-19 increased its impact on research collaboration and monitoring in 2020, Tekton Research’s desire to move to full remote monitoring intensified. The research site soon realized there was a need for a remote source document monitoring solution — one that would enable the upload, management, and sharing of source documents with monitors and sponsors without redacting sensitive patient information.

How Can CROs Create Momentum In An Already Established Brand?

ISR was approached by the chief marketing officer at a ‘Top 5’ large, global CRO with the question, “How do you create momentum in an already well-established brand?” As the CMO, our client was responsible for understanding and communicating to shareholders the current state of their brand. The client felt as if their brand had hit a ceiling and was feeling a sense of stagnation in their marketing efforts. Wishing to ensure continued brand growth, our client needed to know which components of their brand were succeeding and which were falling short. With this information, our client would be able to tell how these dynamics would manifest themselves in the larger organization’s successes and failures.

Strategically Controlling Clinical Trial Costs: 5 Big Takeaways

Ensuring that your trial is delivered with the highest of quality, on time, and on budget is essential given the escalating costs to conduct clinical trials and to avoid unnecessary and often required change orders. This infographic reviews five key takeaways for controlling clinical trial costs while building a focus on quality from the beginning.

Vaccine Development: Strategic Approach And Response During Pandemics

Over the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have sparked ongoing conversations about strategic approaches and responses to pandemics and epidemics. Now with the spread of COVID-19 intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring these life-saving drugs to market faster without impacting product quality, safety, or efficacy.

Are You Ready To Begin Planning Your IND Submission?

Submitting an IND application to the U.S. FDA is a significant step in the development of a new drug or biologics product. But are you ready? In this webinar, experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND.

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July 20, 2021 | 11:00 a.m. EDT

Becoming a partner of choice is a goal for many sponsors, and it all starts with a keen focus on removing the difficulties of trials for sites. Why then do slow and unpredictable clinical trial payments continue to be the #1 complaint from sites, year after year?

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