INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • How Leveraging Cross Collaboration Can Improve Standardization & Adoption Of An eRegulatory Solution
    6/25/2020

    The University of Cincinnati Cancer Institute (UCCI) collaborated with the UC Health Office of Clinical Research (OCR) to rollout an eRegulatory system based on an NCI Standard from Complion. This allowed for enhanced compliance with ability to identify trends and gather quality metrics across UCCI Disease Groups and OCR Departments to inform business decisions and process improvements.

  • Mapping The New Landscape Of Orphan Drug Development
    2/4/2020

    The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

  • Pharmacovigilance: Towards 2020 And Beyond
    1/27/2020

    Patient safety largely depends not only upon safe products but also on appropriate (safe) use of these products after they’re approved for the market. “Safe use” is generally defined by identifying and communicating the benefits and risks of that product. Post-market safety monitoring keeps patients safe. Read how simplification, harmonization, and risk communication are effective tools for safe use.

  • Risk Evaluation And Mitigation Strategy (REMS) Overview
    4/29/2019

    UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.

  • COVID-19 FDA Response: Guidance On Protocol Amendments And Clinical Study Reports In Affected Ongoing Trials
    5/6/2020

    One of the impacts of the COVID-19 pandemic on the conduct of ongoing and planned clinical trials will be the need for protocol modifications to adjust for COVID-19 control measures and COVID-19 illness. This blog review a recent FDA Guidance that offers advice on managing protocol amendments and deviations and documenting changes to the trial.

CLINICAL TRIAL REGULATORY SOLUTIONS

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

  • TransPerfect's device-independent call center solutions allow you to easily and affordably route calls to our global call centers where we intake and process cases, either as part of a clinical trial or in supporting post-marketing pharmacovigilance efforts (adverse events, medical information, product complaints, patient registries, etc.).

  • 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.

  • 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.

  • 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.