Newsletter | May 3, 2021

05.03.21 -- Will Decentralized Trials Create Technology Integration Problems?

 
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Will Point Of Care Laboratory Devices Replace Brick-And-Mortar Labs In Clinical Trials?

Over the past few years, there has been growth in the use of point of care (POC) testing at investigator sites in clinical trials. This article addresses why sponsors do not typically utilize data from POC laboratory devices in regulatory ļ¬lings, the integration of POC laboratory device data with clinical trial laboratory systems, and whether POC laboratory devices will replace brick-and-mortar labs.

Industry Trends In Clinical Development Technology

As electronic data sources become embedded in the clinical development process, systems, processes, files, storage, and approvals are moving away from paper and becoming application dependent.

5 Common Clinical Supply Chain Speedbumps

Clinical trials are so complex, you need to connect planning and oversight from sourcing to shipping and master such requirements as cold chain, border slowdowns, and data privacy.

Best Practices Guide To Data Privacy In Clinical Trials

As life sciences companies grow, the regulatory compliance requirements, and risks, expand as well. These responsibilities extend beyond conventional health-related frameworks (e.g., GxP, HIPAA, etc.) but into the realm of data privacy as well. For high-growth institutions with limited resources and bandwidth, the question arises: what should you do?

Parallelization: Imperative To The Compression Of Clinical Trial Cycle Times

Study start-up, the activities involved at the outset of clinical trials, remains highly inefficient and prone to bottlenecks and errors. Clinical trials that get off to a good start are more likely to execute well and finish on time and on budget — study start-up is the Achilles heel of clinical trials. With unrelenting pressures to rein in budgets and cycle times, the application of project management techniques to study start-up holds the key to optimizing operational efficiencies and compressing timelines. The parallelization technique represents the greatest opportunity to realize efficiency gains that are reproducible across all studies, and not just on an as-needed basis.

5 Crucial Considerations For Selecting A CTMS

Working at a clinical research site can be stressful; from managing patient appointments to tracking study documents, professional tools designed to simplify tasks and improve productivity are critical. A clinical trial management system (CTMS) can streamline the daily activities and boost the overall financial health of a clinical research site.

Unflattening The Curve: Minimize The Impact To Patients Who Depend On Your Successful Clinical Trial

Similar to how the response and immediate action to the “Flatten the Curve” movement in 2020 was executed to dramatically lessen the severity and impact of the pandemic on millions of lives, the actions and strategies implemented in today’s clinical studies will impact how patients in current trials will get their investigational treatments. Without a proactive and comprehensive strategy in place to manage clinical trials during the pandemic, consequences may be severe — especially for those that need treatments the most.

Artificial Intelligence Can Boost Reliability And Speed Of Medical Imaging Analysis In Clinical Trials

Pharmaceutical firms face many challenges in bringing their products through clinical trials — from enrollment delays to data quality issues — and every advantage can make a difference. In image analysis, sponsors can gain a critical advantage by leveraging artificial intelligence (AI) or machine learning (ML) — computer solutions that mimic human intelligence and are continually enhanced and updated to become more accurate as they take in more data.

Ora Streamlines Clinical Trials With Veeva Vault CTMS And BA Insight AppBus Platform

Ora, a full-service contract research organization specializing in ophthalmology, aims to accelerate development timelines for its sponsor clients, so productivity and efficiency are critical to delivering high-quality engagements. To achieve its goal of providing best-in-class clinical services, Ora easily integrates Vault CTMS with other applications using the BA Insight AppBus low-code platform.

Orphan Drugs: Balancing Financial Incentives And Complex Challenges

Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs. Despite the niche, high-risk market, orphan drugs are on the rise because of the financial incentives and benefits companies are receiving for new drug development. Whether your orphan drug is a small or large molecule, there are key strategies that you can adopt to enable a seamless transition from early development into commercial manufacturing, while also balancing your investment.

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