Regulatory Insights

  1. How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency 1/31/2019

    With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.

  2. The Regulatory Evolution And Data Revolution In Medical Device Development 7/4/2020

    The Life Sciences and Healthcare industries are among the most heavily regulated industries in the world. This paper looks at the current, dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to. The in-vitro diagnostics (IVD) sector is also going through regulatory change - a topic that is out of scope for this paper.

  3. 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.

  4. Tackling The EU CTR Compliance Challenge 10/4/2018

    Maintaining disclosure compliance is tricky enough with ClinicalTrials.gov, but when it comes to EU CTR compliance, the complexity rises to a whole new level. As a sponsor, do you find your organization “guilty” of these common errors?

  5. China’s Recent Drug Scandals: What Do They Mean For Foreign Drug Makers? 2/20/2019

    Recent scandals surrounding Chinese drug manufacturers have Chinese nationals looking outward, and have even sparked regulatory reforms. This lost faith in local drug companies begs the question: what does this mean for foreign investors?

  6. Tracking And Managing Global Disclosure Performance 10/4/2018

    The following paper discusses the challenges of tracking global disclosure performance and how clinical trial sponsors can use Atlas Global Compliance to manage track and reduce the risks of non‐compliance.

  7. FDA’s Sentinel System: Strategies For Expansion And Transformation 1/27/2020

    The FDA Sentinel System started as a congressional mandate in the FDA Amendments Act of 2007 and has given rise to one of the world’s premier evidence generation platforms. Read how this system is continuing to be invaluable and is a testbed for future projects.

  8. Rapid Change, Real Promise: The Future Of Rare Oncology Research 12/26/2018

    Insight on the major issues being raised in the rare oncology space today, including patient perspectives on rare cancer research, innovative trial designs, the regulatory landscape, and pending legislation that may impact how studies are conducted.

  9. Small But Growing Biotech Manages Disclosure, Maintains Compliance, And Keeps Its Promise To Patients 4/11/2019

    For this biotech, the big challenge was both a lack of expertise and resources needed to manage registration of trials and posting results. TrialScope provided a proven solution that optimizes the efficiency of disclosure activities, maximizes trial data transparency, and fosters more informed, engaged patients through open research sharing.

  10. Antiviral Products In The Pre-IND Phase 8/3/2020

    Productive pre-IND interactions with FDA are important to the success of any drug development program, including infectious disease product development. This step provides opportunities for makers of infectious disease products to engage with FDA by facilitating early communications between the Division of Antivirals or the Division of Anti-Infectives within OID and sponsors/investigators of potential new therapeutics. Here, we specifically discuss antiviral products at the pre-IND stage, and unique considerations for these products.