INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • 2 Steps For Correcting Non-Compliance With EU Disclosure Regulations
    2 Steps For Correcting Non-Compliance With EU Disclosure Regulations

    To address non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance.

  • A New Reality: EMA Published First Guidance On New MDR/IVDR Rules For Certain Devices
    A New Reality: EMA Published First Guidance On New MDR/IVDR Rules For Certain Devices

    Due to the increasing pace of innovation and blurring boundaries between pharma and device products have led to new drug-device combination products and the need for updated regulatory guidances, the EMA published a Q&A document detailing information for products that need both the drug and the device components to function.

  • Tackling The EU CTR Compliance Challenge
    Tackling The EU CTR Compliance Challenge

    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?

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

    Right-to-Try has been in the news a lot recently, but what does it actually mean for product sponsors? This webinar explores both Right-to-Try legislation and existing Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.

  • Risk Evaluation And Mitigation Strategies: FDA Guidances For Assessing Effectiveness

    In January 2019, the Food and Drug Administration (FDA) released 2 draft guidance documents regarding assessment of Risk Evaluation and Mitigation Strategies (REMS).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.

  • Regulatory Agencies Encourage Use Of Adaptive Designs

    Over the past several years, regulators, including the FDA, EMA, PMDA, have provided guidance on the use of adaptive design for clinical development. Read how the FDA and EMA thinking on adaptive designs has progressed significantly, and support for the approach has strengthened.

  • Understanding FDA’s Priority Review Voucher System

    How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? In this complimentary webinar, Rho’s panel of experts will walk you through the how’s and why’s of the FDA’s Priority Review Voucher program.

  • Taking The Fear Out Of Software Implementation

    Software implementation does not have to be a scary proposition. In this video, implementation experts – with a 100% success rate – discusses what works and why.

  • Ask The IRB Experts

    Clinical research is complicated.  At WCG, we frequently get questions about the ethical conduct of research from clinical team members at biopharma companies and study sites. We know that for many of the questions we get, the person asking is not the only one struggling with that issue. Read the questions your peers are asking – and if you don’t see yours, submit one of your own.

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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.

  • Global Pharmacovigilance And Safety Solutions

    As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.

  • TrialScope Transparency Management
    TrialScope Transparency Management

    CLINICAL TRANSPARENCY
    Clinical trial sponsors are required by law to disclose information on their clinical trials in multiple places. These regulatory requirements continue to change as new mandated registries emerge and the scope of disclosure expands. This dynamic scenario creates a challenge for sponsors who must track and manage disclosure content that is being prepared for different registries, with different requirements.

  • Central Laboratory Solutions
    Central Laboratory 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.

  • Contract Packaging Services For Clinical Trials
    Contract Packaging Services For Clinical Trials

    Ropack Pharma Solutions offers turnkey primary and secondary pharmaceutical packaging services of solid oral dosages into blisters, bottles, flip-top vials, stick-packs and sachets.

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