Regulatory Solutions

  1. Marketing Applications For Regulatory Approval 4/23/2021

    Preparing regulatory marketing applications to their successful conclusions is our focus.

  2. TrialScope Global Disclosure Compliance Overview 11/4/2020

    Global clinical trial disclosure poses a challenge for many sponsors due to disparate tracking tools, teams located around the world and constantly changing regulations. However, sponsors can reduce risk with real-time access, metrics and answers.

  3. PhlexRIM 2/19/2021

    Comprehensive Phlexglobal Regulatory Information Management (PhlexRIM) will help the life sciences organizations effectively and efficiently drive the development, capture, dissemination, control and management of regulatory focused information throughout the product lifecycle.

  4. Pharmacovigilance And Safety Surveillance 4/24/2021

    Delivering safety surveillance before and after regulatory approval for pre-approval and marketed health products.

  5. Electronic Regulatory & Study Binders 4/23/2013

    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.

  6. TrialScope Disclosure Management Brochure 9/24/2018

    TrialScope Clinical Trial Registry Manager (CTRM) delivers the proven solutions clinical trial sponsors need to centralize, track, register, and comply with clinical trial disclosure processes, mitigating compliance risks while giving them greater control over their own clinical trial disclosure reputation.

  7. Advarra eRegulatory Management System Overview 1/27/2021

    Streamline your regulatory process and think beyond the binder. Save time, improve workflows, and enhance regulatory compliance across your organization with a system designed for academic institutions managing a large volume of protocols.

  8. Study Start Up 4/23/2013

    One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel.

  9. PhlexIDMP 2/19/2021

    Start managing your IDMP data with Phlexglobal today! PhlexIDMP is a single regulatory database that will help you to avoid redundant data  that exists within your submissions. PhlexIDMP is based on two key components - controlled vocabulary management and codes - that deliver the best ready to use IDMP management solution.

  10. Institutional Biosafety Committee (IBC) Reviews 3/30/2021

    IBC review involves the deliberate transfer of engineered genetic materials to human research subjects. Read our latest brochure on IBC review.