Egnyte for Life Sciences is a unified data collaboration platform to serve those advancing the science of health. The advanced platform supports features designed to maintain regulatory compliance, support secure sharing, and manage data governance. More than 16,000 businesses, and more than 400 life science organizations, trust Egnyte to provide visibility and control into their most valuable asset, their data. For more information, visit www.egnyte.com/lifesciences
Best Practices Guide To Data Privacy In Clinical Trials
As life sciences companies grow, the regulatory compliance requirements, and risks, expands as well. These responsibilities extend beyond conventional health-related frameworks (e.g. GxP, HIPAA, etc.) but into the realm of data privacy as well. For high-growth institutions with limited resources & bandwidth, the question arises: what should you do?
3 Ways To Survive The Shifts In Life Sciences
Over the past 20 years, the life sciences industry has undergone massive changes, and new software and partners have emerged. There are three key ways that business can serve the dynamic needs of modern drug development.
3 Ways To Mitigate Data Manipulation Risk In Drug Development
A critical output of the drug development process, besides the compound itself, is data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.
Why Life Sciences Needs The Science Of Security
Given the complexities that arise when securing data in drug development and developing software that facilitates common workflows, ensuring best-of-breed security simultaneously is the key to success.
Five Ways To Reduce The Cost And Complexity Of File Sharing
Prompted by COVID, many businesses have already started experimenting with or adopting modern business-class, cloud-based file sharing. Here are the benefits and areas where companies can slash the cost and complexity of file sharing.
Top 5 Remote Work And Data Security Risks In Life Sciences
Remote work increases the level of difficulty of proper data governance and security to prevent attacks like hacks, ransomware, and data carelessness. Read how to mitigate the risks associated with the human side of data governance and information security.
Surviving The Paperwork: Why Seamless Submissions And Good Compliance Envelopes Matter
Are you finding it increasingly challenging to manage your organization’s regulatory submission process? The entire process of developing a drug from preclinical research to marketing takes approximately 12 to 18 years and can cost billions of dollars before a drug is even approved. Learn how the advantages of a good ‘compliance envelope’ can far outweigh its costs by making companies operationally more effective, with a positive impact on the top line.
Top 5 Risks That Can Compromise Your Life Sciences Data
Keeping the clinical trial data secure and compliant is paramount. Restricting access to only those that need it is an essential first step, but there is much more that needs to be done. To help you in your journey, we’ve created a list of five common ways that trial data puts us in jeopardy, and approaches you can take to avoid these risks.
Ditch The Checklist: Why Automation Is The Key To Content Compliance
Checklists work for things like house maintenance; you identify and fix the things that don’t meet building codes, and then you feel safe, and the building inspector is happy. Content, however, doesn’t operate like that. Some content is essentially stateless; because of collaboration or continuously changing data, content assets change. Identifying adherence to compliance controls, therefore, means it has to be evaluated continuously. Automated, continuous monitoring is imperative for companies that depend on their critical content to make business decisions and conduct operations.
The Real Science Behind Data Quality In Pharma
Assessing data quality is not always simple. There are numerous variables to consider. To make it easier to fine-tune these considerations for all business requirements, we've broken them down for you.
Protecting Critical Content: Securing Unstructured Data Assets In Pharma
The safety of business content is a top priority for every company. Especially at a time when data breaches and other cyberattacks threaten the stability of our systems, protecting our data is an essential corporate function. Learn how to make security improvements to minimize the risk of internal and external threats to content by weaving content intelligence and data governance into every layer of the file sharing and collaboration architecture.
How To Safely Collect And Store Patient Data During Clinical Trials
With telemedicine, cloud storage, and electronic record-keeping on the rise, patient data has found itself a common target for hackers. This blog covers the most important security factors for collecting and storing patient information.
Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records
Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
GxP Risk Assessment For Computerized Systems
In GxP environments validating and documenting mission-critical systems are required to ensure the integrity of data and audit-readiness. Yet, given the number of systems used, it is unclear which electronic systems require validation and which do not. This checklist provides a framework for evaluating which software should/not be validated.
Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track
Retrophin is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.
VIDEOS AND WEBINARS
Using Egnyte For Life Sciences As GxP Repository
Transitioning from the research phase to the clinical trial phase is a big step for any company, but it also means challenges, not the least of which means your electronic records need to comply with FDA 21 CFR Part 11 and GxP. In this democast, we will review how to deploy and use a GxP-compliant repository using Egnyte’s industry-focused platform, Egnyte for Life Sciences, without sacrificing usability or security, and without creating administrative overhead.
IND Best Practices: 5 Tips For A Successful Filing
There are many steps that need to be performed in order to assemble an Investigational New Drug (IND) Application. Whether it be consulting with the FDA, using a GxP compliant collaboration platform, or finding a partner, this process is often complex. Despite the numerous steps, it does not have to be an insurmountable goal. This webinar reviews 5 key best practices for assembling your IND and identifies specific tips that you can integrate into your workflow today.
GxP Audit Trails For FDA Compliance
Many companies struggle with ensuring a strong compliance envelope as they transition from an R&D culture to a more-structured, regulated one. In this video we will cover Egnyte for Life Sciences platform overview focusing on audit trails, versioning, and reporting capabilities that can help you overcome your compliance challenges.
Clinical Trials And Business Continuity In The Age Of COVID-19
In this webinar we are joined by Rahul Chaturvedi, an expert in clinical development with 10+ years of experience, who discusses some of the ways clinical trials are being disrupted and how to shift your mindset to take advantage of this time to strengthen your clinical program.
How To Stay Ahead Of Disruptive Trends In Clinical Trials
Clinical trials are evolving. Whether it’s disruptive technology, changing regulations, or external factors. The pace of change is only increasing - along with the complexity of ensuring your trial data is secure and compliant. This session will provide best practices and insight into how to keep pace with the changes and be better prepared for what’s still to come.