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. 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.

  3. 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.

  4. Regulatory Submissions
    6/14/2011
    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.
  5. 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.

  6. Unit-Level Serialization and Packaging Services: Pharma
    4/29/2019

    While regulatory compliance is a major driver for serialization projects, breaches to the Pharmaceutical Supply Chain distribution system are also a concern, as they can pose health risks to patients and financial risks to the supply chain stakeholders. At Bellwyck, our holistic and comprehensive approach to serialization ensures these risks will be mitigated and will maximize your value. We have partnered with industry leader Optel Vision to provide you with a flexible serialization solution that can meet a wide range of requirements.

  7. 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.

  8. 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.

  9. DIA Events And Training Calendar
    2/6/2019

    What's happening at DIA in 2019? Download the DIA Events and Training Calendar to see where and when DIA will be hosting conferences, meetings, short courses, and training opportunities for you and your team. 

  10. 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.