Whitepapers

Delve into the impact of external stakeholder requirements in developing an integrated evidence generation strategy that maximizes product value.

Learn how strategic planning and patient-centric design of real-world studies drive value critical to stakeholder acceptance.

Rare disease clinical research is complex. By shifting perspective and focusing on the patient experience throughout clinical trials, trial sponsors can learn about the unique barriers faced by patients and their loved ones, improve participation rates, and optimize the impact and outcomes of such studies.

Today’s clinical studies are increasingly complex and require patient-centric trial designs, like decentralized trials, more than ever before. As trials incorporate more decentralized components there is an ever-present need for multiple system integrations to support the various trial functions, with the goal being that all trial data flows seamlessly between systems and is stored in one repository for efficient oversight and analysis. These numerous integrated systems require closely managed integration, synchronization, and supportive partnerships to minimize error and maximize efficiency. In this case study, partners endpoint and THREAD dig-in to explore how IRT can be integrated with decentralized clinical trial (DCT) technology, working through tightly integrated workflows, to provide a streamlined process, a better user experience for Sites and Participants, higher quality data and real-time access to information.

There is great value in global, multi-ethnic approaches to early-phase drug development, and they can accelerate the availability of new therapies in Asia.

On May 1, 2023, the U.S. Food and Drug Administration (FDA) released an updated Draft Guidance on decentralized trials. This release shows that the landscape of clinical research is rapidly evolving. The shift towards decentralized clinical trials presents an exciting opportunity for sponsors to improve patient engagement, enhance data quality, and accelerate clinical research. Are you prepared for what’s to come? Download the insight brief to learn more.

Key challenges and strategies to consider when developing devices intended for home-use or deployment in a clinical research setting.

The patient recruitment and enrollment funnel is an overlooked pain point in clinical research. OneStudyTeam addresses inefficiencies in this stage, along with opportunities and strategies for improvement.

Eliminate patient enrollment as a bottleneck for clinical trials. Start by using these strategies to optimize clinical trial enrollment timelines.

Failing to adequately prepare for sourcing and shipping of ancillaries can result in clinical trial enrollment delays and increase operational costs.

In this eBook learn about varying categorizations and how they impact combination product registrations in the US and EU markets.

Whitepaper that examines the characteristics of various FSP models and how they help bring new therapies to market faster while remaining cost-effective.

The pending FDA Guidelines is clear—pharma companies must improve diverse representation in clinical trials. In this whitepaper, Science 37 shares tips and strategies on how to achieve diversity in clinical trials.

This paper analyses the responses from more than 800 US-based clinical trial sites to understand their decentralized clinical trial capabilities and perceptions

Learn about supporting life science companies with more precise data to for optimized patient-centric care.

Decentralized trials (DCTs) have grown in acceptance since the COVID-19 pandemic when mobile research nurses were asked to step in to save hundreds of site-based clinical trials at risk of being postponed or cancelled because of mandated lockdowns. But despite their proven effectiveness, DCTs are still often an afterthought or an add-on option to site-based trials due to cost concerns The perception has been that deploying mobile research nurses to visit patients at their own homes would be more expensive than site-based trials. However, a recent study by the Tufts Center for the Study of Drug Development (Tufts) shows that not only are DCTs more patient-centric, but they also provide comparatively high returns on investments for sponsors.

With innovations in wearables, digital monitors and video capabilities, technology can play a role in efficiently capturing data in decentralized clinical trials. Technology alone often is not enough, however, especially considering the diverse and vulnerable populations who participate in clinical trials. Human intervention by properly trained medical professionals such as mobile research nurses is key to ensuring data consistency and integrity as well as protocol compliance. Given the bond that often forms between patients and their caregivers, mobile research nurses also can help improve patient retention.

Founded in 2015, Decibel is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance. For this growth-stage biotech, Egnyte has been a valuable partner in supporting clinical and regulatory operations, medical writing, biostatistics and data management teams with a single repository for all documentation gathered from CROs and submitted to the FDA and other regulatory agencies.

Drug development has dramatically changed over the past ten years. Specifically, when it comes to GxP compliance and validation. Many biopharma companies struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. In this white paper, we will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

The biotech uses Egnyte to slash its reliance on manual processes so its team can produce better data quality and accelerate drug development.