Regulatory Insights

  1. 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.

  2. Mapping The New Landscape Of Orphan Drug Development 2/4/2020

    The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

  3. Choose The Right FDA Program To Expedite Your Rare Oncology Trial 6/28/2021

    With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment options, researchers, clinicians, and patients may be seeking approaches to accelerate the development and approval of novel therapies. In this blog post, we review the regulatory programs available to expedite treatments for rare disorders and serious diseases.

  4. Effective Way To Ensure Early Statistical Deliveries 4/7/2021

    A biopharmaceutical company had a first-in-human study in patients with solid tumors. They were in need of regular and timely reports to provied to the Safety Review Committee for dose decisions, to support rapid study completion. Cmed offered a solution by building an encapsia database to enable the sites to quickly enter their data and developed a robust and flexible set of programs to generate outputs required by the Safety Review Committee.

  5. Planning The Way Forward In Neurodegenerative Disease Studies 7/14/2021

    The Food and Drug Administration (FDA) recently released specific draft guidance titled, Human Gene Therapy for Neurodegenerative Diseases (ND). This guidance provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.

  6. Pharmacovigilance: Towards 2020 And Beyond 1/27/2020

    Patient safety largely depends not only upon safe products but also on appropriate (safe) use of these products after they’re approved for the market. “Safe use” is generally defined by identifying and communicating the benefits and risks of that product. Post-market safety monitoring keeps patients safe. Read how simplification, harmonization, and risk communication are effective tools for safe use.

  7. The Regulatory Landscape Of Software As A Medical Device 3/29/2021

    A new class of medical software known as Software as a Medical Device (SaMD) is offering innovative ways to capture, optimize and analyze healthcare data with the goal of improving health by utilizing analytics to manage and optimize health outcomes. However, this rich field of technology is evolving more quickly than regulators can keep up. In this webinar, the panelists will define what is considered a SaMD and explore key strategies to bring it to market successfully through regulatory strategy, clinical impact and considerations for patient engagement and participation.

  8. The Power Of Integrated Research Administration 4/1/2020

    Read a “Tale of Two Health Systems,” one with a centralized research administration and one without. A story we’re sharing in case it helps others in the research community.

  9. Key Changes In The Revised EMA Guidance On Clinical Trials During COVID 4/26/2021

    In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent changes in the global health landscape. Here’s an overview of what’s new.

  10. DIA NOW Sample Video - FDARA Section 504 8/20/2020

    FDARA Section 504 eliminated the orphan exemption for pediatric studies for cancer drugs and instead empowers the FDA to require pediatric assessments of new therapies.