The European Medicines Agency (EMA) has expanded the use and scope of remote source data verification (rSDV) in clinical trials. Read how the updated guidance justifies the use of rSDV on more trials with fewer restrictions.
Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines. Download the case study.
In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.
Preparing your market application and planning the lifecycle management of your development program are critical to moving your product through early-phase trials and achieving commercial success. Approval in the United States and European Union paves the way for a drug’s acceptance in many, but not all, other parts of the world — so which additional countries should you consider incorporating in your trial strategy?
While the new regulations on medical devices and in vitro diagnostics aim to reduce risks associated with medical devices, their implementation calls for a focused effort from device manufacturers. One particular document presents a challenge for manufacturers, since they will need to consider patients a target audience. Article 32 of the MDR requires creating a summary of safety and clinical performance (SSCP), which device manufacturers will need to prepare annually to remain in compliance with the regulation.
In this video, learn why Advarra is trusted by global clinical leaders to enable safety, compliance, & efficiency in their research. Advarra advances human health, by making clinical research safer, smarter, and faster.
When it comes to trial master files (TMFs), questions about original documents and copies are raised more than any other topic. A lot of confusion surrounds two factors: what constitutes a certified copy and when a certified copy is required. While recent regulatory guidance has helped determine best practices that eliminate some of this confusion, questions still remain. This article answers the most frequently and commonly asked questions about the certified copying process for TMFs.