Regulatory Solutions

  1. TrialScope Transparency Management
    9/24/2018

    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.

  2. Regulatory Affairs
    6/14/2011

    As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance that ensures patient safety and regulatory compliance.

  3. Pharmacovigilance System Master File
    4/23/2013

    One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.

  4. DIA 2019 Annual Meeting Schedule At A Glance
    2/6/2019

    Download the at a Glance Schedule for DIA 2019 Global Annual Meeting - San Diego - June 23-27.

  5. Reduce Cost And Effort When Servicing Clinical Trials In Canada
    2/6/2018

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

  6. TrialScope Disclosure Management
    9/24/2018

    PharmaCM is a clinical trial disclosure platform designed specifically for the regulated environment of Life Sciences. PharmaCM is used to manage the complex process of authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data. Disclosure content is very dynamic. Clinical trial data is constantly being updated, modified and formatted for specific registries such as ClinicalTrials.gov and EudraCT.

  7. TrialScope Transparency Management Brochure
    9/24/2018

    TrialScope Clinical Trial Transparency Service (CTTS) enables clinical trial sponsors to engage with patients and the public via a user-friendly, high impact website to openly share clinical trial information and results, demonstrating leadership in transparency while optimizing trial recruitment and retention.

  8. Clinical Trial Management Brochure
    5/3/2019

    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.

  9. Global Pharmacovigilance And Safety Solutions
    4/23/2013

    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.

  10. How Biorasi Optimizes Clinical Solutions
    4/26/2019

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