Whitepapers

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.

Seeking faster startup for cell and gene therapy studies? Sponsors can streamline IRB and IBC reviews by coordinating the committees’ activities via a vendor offering both resources in-house.

Curious about mRNA technology and the regulatory requirements for its use in clinical trials? Advarra’s gene therapy research experts respond to commonly asked questions.

How can you tell if your study requires IBC oversight? Start with these common terms found in research protocols requiring IBC review.

Whether used exclusively or as part of a hybrid approach, patient-centric decentralized clinical trial methods enable investigators to more easily recruit and retain a diverse patient population. DCTs cannot, however, yield their full spectrum of advantages without proper planning and attention to detail. This checklist can help guide sponsors and CROs toward a successful trial.

There is a growing body of evidence that hybrid and decentralized clinical trials are here to stay. What was once a nice-to-have is quickly transforming into a must-have. The catalyst for this dramatic shift was the COVID-19 pandemic. To aid sponsors and CROs in fully realizing the benefits of decentralized clinical trial methods moving forward, this whitepaper extracts the lessons learned from the pandemic and their implications for clinical trials now and in the future.

Today, we live in a world where we have the capability to reach anyone, through decentralized clinical trial techniques and we have an ethical obligation to implement them.

In this whitepaper, Science 37's Diversity & Inclusion leaders share strategies on how to achieve diversity in clinical trials in order to adhere to the FDA's Guidance.

Decentralized clinical trials are not an all-or-nothing approach, they encompass a spectrum of hybrid designs that when implemented correctly deliver transformative results.  In this white paper, Science 37 leaders discuss where decentralized research is now, and where we are headed. Experts unveil new—and proven— models and the benefits they deliver, from accelerated patient enrollment and improved experience to real-world representation.

A biopharmaceutical company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. Only later did they discover that the Trial Master File documents were scattered across hundreds of boxes of paper and several hard drives. The company was facing critical submission deadlines and the risk of losing financial incentives related to the product acquisition – with zero insight into potential TMF quality and completeness issues that could lead to a failed inspection and delayed submission. Read the case study, “From Liability to Asset: A TMF Rescue” to discover how Phlexglobal’s unique blend of TMF expertise and services turned a “black box” into an inspection-ready TMF – ahead of schedule.

Ensuring ongoing inspection-readiness of a Trial Master File can present challenges to even the most well-prepared organization - with unforeseen quality or completeness issues cropping up when least expected. To help identify and avoid the most common errors, Phlexglobal’s TMF experts have compiled a handy guide, “5 Reasons Your TMF Isn’t Inspection-Ready (and what you can do to fix it).” You’ll discover the top causes of inspection findings, as well as pragmatic steps to improve inspection-readiness. Want to reduce the uncertainty and risk of an inspection, and be better prepared to pass this critical test when it happens? Download the helpful guide today.

Explore how an integrated approach to the clinical research industry’s technology landscape can remove friction, improve access and diversity, save time, and better serve patients.