Egnyte

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.

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.

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.

“If it’s not documented, it didn’t happen.” This is a well known saying to Quality teams in biotechnology. What it means is that every step in the development, clinical, and manufacturing processes needs to be documented or else regulators can’t accept that it happened. In the eyes of the FDA, without documentation, the research, the clinical trials, or the manufacturing process needs to be repeated. This results in added expense, costly delays, and an erosion in trust from regulators, investors, and consumers. In this piece, Egnyte chronicles the nine elements that successful Quality & Compliance teams adopt to keep pace with the speed of discovery. Learn the best practices for an effective quality documentation process.

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, Egnyte will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

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.) into the realm of data privacy. For high-growth institutions with limited resources & bandwidth, the question arises: what should you do? In this document, Egnyte chronicles some of the regulations affecting the life sciences industry and share 5 activities to help your organization comply with these new and dynamic laws.

***Live: Wednesday, Nov. 18, 2020 at 2pm EST| 1pm CST| 11am PST*** . ***On demand available after final airing until Nov. 18, 2021***