Newsletter | September 13, 2021

09.13.21 -- A Stem Cell Company Overcomes The Challenges Of International Trials

 
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3 Ways To Mitigate Data Manipulation Risk In Drug Development

A critical output of the drug development process, besides the compound itself, are data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.

A Patient-Centric Approach To Managing Clinical Trial Complexity

Three current factors driving up average the clinical trial study duration are executional complexity, hyper-customization, and operating fragmentation. It’s nearly impossible to reduce any of these factors. Complexity isn’t going anywhere, dataources are only increasing, and as research expands, so does the number of organizations that support it, which too easily leads to fragmentation. Instead of reducing factors, let’s make better ways to manage them.

Easing The Patient’s Journey Into Clinical Research

As an advocate for patients and a patient myself, I’m often asked the question, “Why don’t more patients participate in clinical trials?” There are many reasons I hear from fellow patients about why they have not participated in a clinical trial, including not being aware of trials as a treatment option, not knowing where to find trials they are eligible for, and not wanting to be a “guinea pig” in the name of research. At the heart of all these reasons is a lack of information and processes that meet patients where they are.

The Human Touch Of Decentralized Clinical Trials

When we talk about decentralized clinical trials (DCTs), the conversation usually centers on the technology; however, DCTs require more than technology. There is an equally important human component driven by specialized study teams, including mobile research nurses and phlebotomists who engage patients where they live. This blog explores how mobile research teams have become the unsung heroes of the tech-enabled clinical trials movement.

Five Ways To Get To IND/IMPD Faster

How do you get to IND/IMPD faster without sacrificing quality and future commercialization goals? Our experts share a few considerations when thinking about accelerating and optimizing your early development process.

Empowering Clinical Trial Sponsors With Analytics

This article examines data challenges faced by sponsors and the underlying problems driving those challenges. It also details fast and flexible new processes and solutions designed to help overcome these challenges by serving sponsors’ ever-increasing need to analyze complex data.

Enabling Personalized Medicine Through Big Data

While the term has been used more frequently in recent years, personalized medicine is not a new concept; healthcare professionals have been tailoring treatment to an individual’s specific needs since the advent of medicine. However, the groundbreaking advancements being made today allow us to understand a patient’s potential susceptibility to certain diseases, as well as their predicted response to treatments. Facilitating this shift is the availability of ‘Big Data.’

Drug Accountability And Returns Management

eClinical technologies are becoming more commonplace in drug development as biopharma adopts validated methods to maintain compliance, patient recruitment, engagement, and safety, and supply chain forecasting. This white paper illustrates how sponsors are using electronic solutions for drug accountability (DA) because they recognize the significant increase in efficiency and accuracy that these methods provide.

Trial Tokenization And Linking To Real-World Data: Extending The Effectiveness And Safety Analysis Of A New Focal Seizure Treatment

Recently, a biopharmaceutical company completed a 36-week Phase 4 study of 175 patients across 40 trial sites to evaluate the effectiveness and safety of a recently approved antiseizure medication as adjunctive therapy in focal seizure. Read the available case study to find out more.

Scientific Functional Outsourcing Solves Sample Management Challenges In Clinical Studies

A major pharmaceutical company faced significant challenges managing the life cycle of its outsourced clinical and preclinical studies. The client’s internal analysts were developing assays and transferring them to global laboratories while also juggling the management of vendors and overseeing assay performance. However, without centralized, dedicated oversight, clinical timelines and quality were being challenged.

Global Pharma Company Dramatically Improves Collaboration, Communication, And Compliance In Trials

A Top 5 global pharmaceutical company wanted to help sites do everyday tasks more efficiently, making it easier for site staff to adhere to the protocol and deliver high-quality data. After evaluations and pilots, the company deployed IQVIA Technologies’ Investigator Site Portal (formerly DrugDev) in a four-phase approach that delivered benefits each step of the way.

The Role Of Genomics In Clinical Trials

Genomics has come a long way from the days of being primarily a discovery tool. It used to be that essentially all the genomic data that were being produced as part of clinical trials was purely exploratory in nature. This is still being done, but now we're also translating those insights into real uses. In this podcast we discuss the use of broad genomic features such as microsatellite instability and tumor mutational burden as biomarkers, in addition to specific point mutations that have been in use for some time.

Oncology Research And Care: Reimagining Digital Innovation

During this webinar, speakers will discuss how they are successfully deploying wearable and remote monitoring technologies to improve clinical outcomes in patients living with cancer.

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