Regulatory Insights

1. A New Era In Dermatology: Study Design, Regulatory Strategies, And Patient Participation 10/19/2020

   This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical elements when devising effective recruitment and retention strategies.

2. Lay Summary Development—The Oregon Trail Of Regulatory Writing 8/15/2019

   The world of lay summaries is a bit like the Oregon Trail, where authoring and review processes have yet to be navigated by many study sponsors. Impending regulation throws study teams into the Wild West of regulatory documentation, where they are forced to use available resources to keep up with legislation. What happens when resources are limited or the path is unclear?

3. Best Practices For Effective Quality Documentation Processes In Drug Manufacturing 6/22/2021

   There is always a balance between speed and compliance, while others struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. Needless to say, developing a quality and compliance posture that meets the needs of both masters (business stakeholders and auditors) is a tall order. In this piece, we will chronicle the trends that successful quality & compliance teams adopt to keep pace with the speed of discovery.

4. 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.

5. Leveraging A Central IRB Office To Improve Turnaround Times And Consistency 3/30/2021

   With over 100 sites in the Academic and Community Center Research United (ACCRU) research network, utilizing a central IRB office was essential to increase review consistency and turnaround times.

6. 10 Key Steps To Help You Prepare For IDMP Compliance 5/26/2021

   Use this guide to benefit from Phlexglobal’s experience helping some of the world’s largest pharmaceutical companies prepare for IDMP. You’ll save time and effort by leveraging a practical and proven blueprint for implementing IDMP - from performing an effective data source analysis and determining data governance and processes, to defining your system architecture. What’s more, our IDMP experts share valuable tips throughout the guide from their hands-on IDMP experience.

7. EMA Expands Use Of Remote Source Data Verification 3/8/2021

   The European Medicines Agency (EMA) has expanded the use and scope of remote source data verification (rSDV) in clinical trials. Read how the updated guidance justifies the use of rSDV on more trials with fewer restrictions.

8. The Value Of Data Standards In Clinical Trials: The Time Is Now 12/3/2019

   On an organizational level, failure to establish data standards upfront makes it difficult – and in some cases, impossible to connect data across disparate systems for efficient study execution. The adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. Continue reading to understand the history of data standards and where they are headed in the future.

9. New FDA Certificate of Confidentiality Guidance: What Does It Mean For You? 1/12/2021

   FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures Act (“Cures Act”), which was passed in 2016. In this blog we discuss what has and has not changed regarding CoCs and how this new guidance impacts research sponsors, research sites, and institutional review boards (IRBs).

10. Understanding Recent Regulatory Changes For Pediatric Oncology Trials 11/14/2019

    While children typically have a better cure rate for cancer, biopharma companies have traditionally shied away from pediatric oncology trials, resulting in fewer treatment options. However, the regulatory landscape is evolving, and the demand for innovative therapies for pediatric cancers is becoming increasingly vocal.