Whitepapers

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.

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.

While it can take more than a decade to bring a new drug to market, each year is filled with many new challenges and complexities. All of this change and uncertainty makes strategy and planning extremely daunting for Life Sciences companies: How do you prepare your organization for the future, without overcomplicating the present? How do you mitigate risk, and maximize agility? Join a live discussion with Karl Fischer, Sr. Director, IT & Operations at IO Bio which develops leading-edge therapies for the treatment of solid tumors. The company also has several candidates in early phase clinical trials.

There are lots of eTMF solutions out there. And because the technology has advanced so quickly, even seasoned professionals can benefit from a recap of what is available to streamline the collection and classification of trial data. In this guide, you’ll learn how to evaluate any eTMF solution based on how well it serves you in three areas.

Allucent’s Katy Moore, Pharm. D., R.Ph. President, Clinical Pharmacology Modeling and Simulation, offers insightful commentary for small and mid-sized biotechs developing scientific breakthroughs. Learn from Katy’s expertise how applying modeling and simulation can improve drug development and help bring new therapies to light.

If the last few years have taught us anything, it’s that so much more can be achieved when all players in the life sciences and pharmaceutical industries work together in a truly collaborative way. The opportunity for the clinical development industry is to take what we have learned about how we can work together and use this to continue to drive progress. To strategically support clients, at ICON, this means partnering with sponsors in a way that goes beyond a traditional CRO. It means being a trusted partner.

Download the Executive Oncology Clinical Trial Playbook to discover the premier, patient-centric strategy for solving hallmark challenges in oncology trials.

Europe’s new medical devices regulation (MDR) is four times longer than the previous medical device directive (MDD), and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them—from pre-clinical through post-market.