Decibel Therapeutics case study
January 10th 2023Founded 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.
Best Practices for 21 CFR Part 11 and GxP Validation for Electronic Records (Jan 2023)
January 10th 2023Drug 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.
Navigating Growth for Biotech Start-Ups
January 10th 2023While 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.
The Evolving Relationship Between Sponsors and Contract Research Organizations
December 8th 2022If 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.
Medical Device Safety: Understanding Europe's New Medical Devices Regulation
October 25th 2022Europe’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.
DCT Planning Checklist: Your Guide to Ensuring a Successful Decentralized or Hybrid Trial
September 26th 2022Whether 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.