How do regulatory requirements within the medical device industry impact a database build? What are the important items to be aware of? In this blog, we will look at these and other questions, with a focus on the data management/database build work within medical...
Does Size Matter? Rescue from a large CRO
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...
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
Webinar – 2024 IVDR Sprint Series: How to Deal with Regulatory Requirements when Collecting Clinical Performance Data
Mastering Time and Compliance How to Deal with Regulatory Requirements when Collecting Clinical Performance Data IVDR imposes stricter requirements for clinical evidence, including a higher level of scrutiny and more stringent criteria for study design,...
Webinar – 2024 IVDR Sprint Series: The Clinical Challenge – Addressing Increased Evidence Requirements in the EU IVDR Era
The Clinical Challenge Addressing Increased Evidence Requirements in the EU IVDR Era In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of...
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...
SCDM Live Annual Conference
Join Us at SCDM September 29–October 2 | Boston, Massachusetts Visit us at booth #512Meet With Our TeamHeidi JermanDirector, Sales OperationsDanita HarrisSVP, Clinical Data ServicePaul MasonSVP, Business DevelopmentSchedule a Meeting
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...