Regulatory Insights

41. What Level Of Review Does Your Study Need? 1/21/2020

    The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study startup.

42. Regulatory Compliance: An Increasing Burden On Sites 6/25/2020

    As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. But a new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.

43. Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar 5/7/2019

    In January 2019, the US Food and Drug Administration (FDA) updated its 2015 draft guidelines for drug discovery in rare diseases. The update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of the development process. In this webinar, learn about the core elements of the new guidance plus the latest recommendations and instructions from the agency along with practical examples and applications.

44. Managing Conflicts Of Interest In Clinical Research 4/1/2020

    Managing conflicts of interest in clinical research is a critical mission for many reasons.Here we discuss the need for conflict of interest policies, examine the role of an IRB in managing conflicts of interest, and review key elements an IRB’s policy should include.

45. The Case Of The Elusive Protocol 2/3/2020

    A client required a chart review to evaluate survivability of pediatric patients with a rare metabolic bone disorder. By trying different protocols and overcoming complex issues of informed consent that had to be resolved before the study was successfully completed, they were able to successfully deliver a final clinical study.

46. CCDS Or Local Labeling, A Chicken-And-Egg Situation? 2/25/2020

    In this blog, UBC’s Dr. Luca Cariolato, Sr. Safety Scientist, speaks to the importance of developing a Company Core Data Sheet (CCDS) before local safety information.

47. What Is A TMF Certified Copy? 2/11/2021

    When it comes to trial master files (TMFs), questions about original documents and copies are raised more than any other topic. A lot of confusion surrounds two factors: what constitutes a certified copy and when a certified copy is required. While recent regulatory guidance has helped determine best practices that eliminate some of this confusion, questions still remain. This article answers the most frequently and commonly asked questions about the certified copying process for TMFs.

48. Panel Discussion On IDMP And Data Preparation 1/29/2021

    In this webinar, our panel of experts will discuss the innovative approaches they are taking to manage IDMP, a vital part of pharmaceutical commercialization. Topics will include ways to improve data processes across the regulatory lifecycle by utilizing advanced technologies such as AI-driven automation.

49. Regulatory Oversight On Gene Therapy In The U.S. And EU 10/9/2019

    Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. With the rapid evolution of the gene therapy field, regulatory agencies have been working to keep pace with these scientific and clinical breakthroughs. An understanding of the regulations and guidance documents reflecting regulator current thinking surrounding gene therapies is essential to success.

50. Guidance For Remote Monitoring For Sponsors And CROs 5/1/2020

    Guidance for implementing remote monitoring as a broad policy at the site level. In light of COVID-19, Veeva proposes that sites and sponsors take a risk-based approach to updating policies and study documents to include only critical elements needed in order to implement remote monitoring quickly while not introducing administrative burden on teams.