Regulatory Insights

  1. MDR: A Landmark Regulation And What It Means For Clinical Research
    4/14/2019

    We’re at the cusp of a new era for medical device research regulations. What will be necessary to meet new MDR regulations? Data – and more of it than ever. Along with the aims of MDR come a clinical trial data management complexity that might cause some growing pains for the medical device industry.

  2. 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 eciency of disclosure activities,
    maximizes trial data transparency, and fosters more informed, engaged patients through open research sharing.

  3. The Top 5 Questions To Ask When Developing A REMS
    3/25/2019

    Unsure if a REMS is needed during product development? This article will answer that question and give guidance if implementing a REMS is necessary.

  4. Clinical Labeling: Looking Ahead
    3/18/2019

    As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.

  5. 3 Big Updates To Clinical Trial Regulations In China – And Why They Matter
    3/14/2019

    With such abundant clinical trial opportunities in China, and such a wide range of innovative eClinical technology available to take advantage of them, there has never been a better time to be a clinical researcher.

  6. SCOPE 2019 Highlights – Beyond The Pilot, Moving Towards Implementation
    2/27/2019

    Recently, nearly 2000 participants attended the 10th Annual Scope Meeting. Read the expert perspectives, insights gained from lessons learned and forward-looking predictions across 10 parallel tracks focused on functional areas and emerging disciplines within clinical development.

  7. 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?

  8. 505 (b)(2) vs. ANDA: How Complex Drugs Fit In
    2/7/2019

    Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

  9. Industry Thought Leaders Share Clinical Trial Disclosure And Transparency Predictions For 2019
    1/31/2019

    With buzzwords such as patient centricity, patient experience and health literacy rapidly becoming the new reality, executives from TrialScope share their predictions for the coming year.

     

  10. With Investors’ Eyes On Biotechs, Biotechs Must Keep Their Eyes On Transparency
    1/31/2019

    Small and mid-size pharmaceutical companies seeking funding or interested in being acquired up by a larger pharma company should not ignore the importance of disclosure, transparency and compliance when it comes to financial matters.