INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S.

    The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.

  • Comparative Analysis For Non-IND Sites

    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.

     

  • Improving Compliance While Reducing Resources

    A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).

  • Cytel's Response: EMA Guidance On The Management Of Clinical Trials During The COVID-19 (Coronavirus) Pandemic

    On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic. Here is a review of selected elements of the guidance, interpretations and recommendations.

  • How Continuous Publishing Speeds Regulatory Submissions

    Continuous publishing replaces serial publishing with a parallel process where regulatory teams identify issues in real time rather than waiting until the end. This allows regulatory teams to resolve validation errors faster and eliminate cumbersome manual hand-offs to significantly reduce time from planning to submission.

  • Vetting Your Vendor: A Reputation For Success

    When researching vendors, particularly in the tech space (and especially in clinical trial disclosure), you should look at more than just the price tag. Do your due diligence. How long has the vendor been in business? What does its client roster look like? What kind of reputation does it have in the industry?

  • Centralized IBC Review Benefits On Research

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

  • Ensuring Safety And Multivigilance Compliance Across The Product Lifecycle

    The regulatory landscape for safety has changed dramatically over the last four years and shows no signs of slowing down any time soon. This Webcast provides an update of the current situation worldwide, a preview of what the next few years will bring, and a solution using Oracle Safety Cloud to remain compliant through it all. Hot topics such as Brexit, combination products, E2B(R3), EVDAS/eRMR, medical device regulations, and IDMP are also included.

  • Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access Programs

    Programs providing seriously ill patients with early access to investigational products are of great interest to the public, but what are the implications to pharmaceutical and biotechnology product companies? This article examines Right-to-Try legislation as well as FDA’s existing expanded access programs from the perspective of companies who are considering providing investigational products to patients with serious or life threatening diseases that have exhausted all other treatment options.

CLINICAL TRIAL REGULATORY SOLUTIONS

  • Clinical Trial Management Brochure

    For more than 25 years, Bellwyck has been a true partner in developing smarter solutions for the pharmaceutical industry — from clinical trial to commercialization. Our consulting services start with a dedicated project management team led by a single point of contact throughout your project.

  • Ten Big Questions To Ask Your Clinical Transparency Solution Partner

    When considering clinical trial disclosure solutions, it is important to understand the potential partner’s practical experience and how their solution fits your compliance needs today and in the future.

  • Regulatory Submissions Regulatory submissions are the most critical milestones in your clinical research program. Quality submissions can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life.
  • Reduce Cost And Effort When Servicing Clinical Trials In Canada

    Contracting an in-country clinical depot helps bring costs and timelines under control.

  • Electronic Regulatory & Study Binders

    All clinical trials collect regulatory documentation in order to receive authorization to conduct the trial at investigative sites. Trials require a Regulatory Binder and many keep separate Study Binders.