THE CHALLENGE Missed timelines and EDC build errors compromised the potential success of the company’s phase 1 study.THE SOLUTION Experienced team members and robust internal reviews resulted in a timely, high-quality EDC build and data management plan.THE OUTCOME...
Prioritizing Patient Safety and Fostering Innovation with the MHRAs New Roadmap for Medical Devices
On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework - Roadmap towards the future regulatory framework for medical devices. The comprehensive plan charts the course for strong regulations...
Strategies for Successful Clinical Data Management Rescue Studies
What is a rescue study? A rescue study is a clinical trial that is being conducted by a new vendor after having previously been conducted by another vendor or in house by the sponsor. The reasons for the change may be based on issues negatively affecting timelines,...
Automation and the Future of Clinical Data Management
The Role of Scientific/Medical Literature Screening and Review in Pharmacovigilance
Why search the scientific and medical literature? “Scientific and medical literature is a significant source of information for monitoring of the safety profile and of risk benefit balance of the medicinal products, particularly in relation to detection of new safety...
Challenges for Medical Device Database Builds and Strategies to Overcome Them
What are some of the challenges with database builds for medical device studies, given the current regulatory requirements? What are the important items to be aware of? In this post, we will look at these and other questions, with a focus on data management and...
Automation and the Future of Clinical Data Management
Automation in clinical data management (CDM) is becoming increasingly popular due to the increasing volume and complexity of data being generated by clinical trials, as well as the need to improve the efficiency and accuracy of CDM processes. Check out the infographic...
Centralized Risk Reporting, Escalation, and Governance (CRREG) Platform
According to the most recent draft of the International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6(R3), “The aim of monitoring is to ensure the participants’ rights, safety and well-being and the reliability of trial results as the...