INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • The Regulatory Landscape Of Software As A Medical Device

    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.

  • What Is A TMF Certified Copy?

    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.

  • 10 Key Steps To Help You Prepare For IDMP Compliance

    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.

  • IND Best Practices: 5 Tips For A Successful Filing

    There are many steps that need to be performed in order to assemble an Investigational New Drug (IND) Application. Whether it be consulting with the FDA, using a GxP compliant collaboration platform, or finding a partner, this process is often complex. Despite the numerous steps, it does not have to be an insurmountable goal. This webinar reviews 5 key best practices for assembling your IND and identifies specific tips that you can integrate into your workflow today.

  • 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.

  • Risk Evaluation And Mitigation Strategies: FDA Guidances For Assessing Effectiveness
    8/5/2019

    In January 2019, the Food and Drug Administration (FDA) released 2 draft guidance documents regarding assessment of Risk Evaluation and Mitigation Strategies (REMS). These documents are meant to provide industry additional information to more accurately assess the effectiveness of their REMS. This article gives an overview of each of these documents and what they could mean for you.

  • Comparative Analysis For Non-IND Sites
    4/1/2020

    A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
    coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward.

     

  • 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.

  • Centralized IBC Review Benefits On Research
    4/1/2020

    Gene therapy research is beginning to boom in the clinical setting. This blog summarizes the growth, risks, and regulatory requirements for gene therapy research.

CLINICAL TRIAL REGULATORY SOLUTIONS

  • Remember the time when laboratory kits were ordered and reordered by sites faxing in pieces of paper, and laboratory reports were faxed and express mailed to investigative sites around the world? Sadly that time is still here for many central laboratory providers.

  • As you begin your journey to adopting an eRegulatory solution, choosing which system to adopt can seem like a daunting task. How can a first-time buyer sort through the bells and whistles to parse out what elements are truly necessary?

  • Best-in-class processes coupled with industry-leading technology to fight for your trial’s success.

  • To mitigate the uncertain clinical trial landscape and make better data-driven decisions, clinical development groups have turned towards real world data (RWD) to augment and inform their understanding of the disease and treatment landscape. Integrated Evidence from Acorn AI provides access to a one of a kind cross-sponsor, regulatory grade, patient-level clinical trial dataset with pre-integrated real world assets to help clinical developers make critical data-driven decisions throughout the product development lifecycle and increase their probability of success.

  • The DIA NOW Knowledge Service is your trusted source for the latest trends and up-to-the-minute updates on a wide variety of topics from across the healthcare continuum. With access to recorded sessions drawn from DIA’s more than 60 annual meetings taking place around the world, augmented with breaking news and analyses from DIA’s renowned publishing group, DIA NOW is your go-to resource for staying abreast of your field.