Regulatory Articles. App Notes, Case Studies. & White Papers

41. 3 Ways To Survive The Shifts In Life Sciences 1/6/2021

    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.

42. 3 Ways To Mitigate Data Manipulation Risk In Drug Development 1/6/2021

    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.

43. Why Life Sciences Needs The Science Of Security 1/6/2021

    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.

44. Success At Speed: Best Practices To Accelerate Vaccine Development 12/18/2020

    This collection of articles documents each step in the vaccine development journey and how technology and partnerships make the difference in getting medicines to patients when they need them most.

45. Surviving The Paperwork: Why Seamless Submissions And Good Compliance Envelopes Matter 12/10/2020

    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.

46. Top 5 Risks That Can Compromise Your Life Sciences Data 12/10/2020

    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.

47. Ditch The Checklist: Why Automation Is The Key To Content Compliance 12/10/2020

    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.

48. Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records 12/7/2020

    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.

49. Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track 12/7/2020

    Travere Therapeutics 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.

50. Navigating Regulatory And Development Milestones 9/17/2020

    This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.