Newsletter | October 28, 2020

10.28.20 -- 4 Practical Ways To Improve The Patient Experience In Clinical Trials

 
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Embracing Diversity And Inclusion
Industry Insights
When Clinical Trials Meet The Real World: Bridging The Experimental And Post-Launch Divide With Data Integration

Real-world evidence and pooled clinical trial data are becoming increasingly available, linkable, and minable to find valuable insights quickly. As we evolve into a new era of data integration, biopharma companies stand to benefit enormously from bridging the experimental and post-launch worlds of clinical data to support the entire product life cycle.

The State Of Gene Therapy In Dermatology

When it comes to dermatologic conditions, gene therapy is still in its very early stages. However, we are seeing promising potential solutions for some rare genetic dermatology diseases, as well as ongoing research in more common skin conditions. In our first article, we reviewed gene transfer techniques and gene delivery systems that could potentially be used for treating dermatologic conditions. Now we turn our attention to the current state of gene therapy for dermatologic conditions.

Overcoming Common Challenges Of Clinical Data Review

Clinical data review is an intrinsic component of clinical development aimed at assuring patient safety, determining drug efficacy, and assessing data quality. It involves rigorous analysis of a broad variety of clinical trial data and often necessitates integration of data from multiple sources in order to extract actionable insights. Here, we look at some of the main challenges of clinical data review and discuss effective strategies to address these, before explaining how our solutions can be deployed to bring urgently needed therapeutics to patients faster.

Multivigilance In The Cloud

Manufacturers must monitor how each product they sell performs with real patients as they use it outside the carefully controlled conditions of a clinical study. This process of multivigilance — the management of safety information for different kinds of medicinal products such as drugs, vaccines, medical devices, and combination products — is required throughout the entire product life cycle. Continue reading to learn how cloud technology makes patient safety less expensive and more efficient.

Tips To Overcoming Sponsor Resistance When Adopting An eRegulatory System

While electronic document management is becoming more mainstream, it’s still considered uncharted territory for some research sites. The transition is often approached with trepidation, fear, and questions. Over the past several years, we have helped many sites move toward a paperless environment. And in our experience, we’ve found sponsor pushback to be a common concern. To that end, we are offering a few tips to ease the apprehension.

Strategies To Optimize Virtual And Decentralized Study Designs

Understanding how to incorporate technologies and strategies that decrease the reliance on brick and mortar sites and bring the study to the patient is critical across all phases of drug development in today’s challenging environment.

Managing Temperature Excursions: Key Pointers That Must Be Addressed

The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber — from packaging, handling, storage, and distribution of temperature-sensitive investigational medicinal products (IMP), all the way to the investigator site. This ebook provides top tips on the best course of action to take, and also provides summary recommendations for sponsors on how to handle cold chain or temperature-sensitive IMP across the supply chain, up until delivery to the investigator site.

The Superpowers Of Clinical Trial Data For Patients, Sponsors, And Recruiters

Mike Wenger, TrialScope vice president of patient engagement, discusses the patient journey for clinical trials, challenges in clinical trial recruitment, and the hidden superpowers of clinical trial data.

Supply Chain Models For Global Trials: Singapore As The APAC Gateway To The World

With an increasing number of clinical studies being conducted in the Asia-Pacific (APAC) region, there is a growing need for streamlining import and export strategies and clinical supply support. Multiple factors, including positive changes in clinical research regulations, reduced costs to run trials, and large urban-centered populations, are attracting sponsors to the region. Watch this webinar to get expert insight on using Singapore as a clinical supply hub.

Three Considerations For A Successful Global Sample Processing With A Central Laboratory

Sample preparation and processing are crucial steps in immuno-oncology, cell-based and gene therapies, and diagnostics, and obtaining timely, high-quality preparation and processing services on a global basis is a universal challenge. This webinar considers three keys for successful global sample processing: specimen collection and transport, consistency in analytical technique, and biostorage.

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October 29, 2020 | 1:00 PM to 2:45 PM EDT

Join IBM on October 29 for a free digital event focused on sharing insights to become more efficient, resilient organizations through inspiring talks, expert and peer panel conversations, and one-on-one meetings.

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CRO Selection: Insider Tips On Selecting The Best Outsourcing Partner
 

Of all the tasks that are handled by executives in clinical operations, few bring as much anxiety and stress as the selection of a CRO partner. Make the right choice and your trial will be a breeze. Make the wrong choice and your trial can go off the rails and require the necessary but hated task of CRO replacement.