Clinical Trial Design
Clinical Trial Design
Design studies that generate the right evidence for regulatory decisions and trial success.
Study Management
Study Management
Keep your study aligned across timelines, sites, vendors, risks, and device accountability.
Safety Monitoring
Safety Monitoring
Protect data quality, patient safety, and site performance with device-focused monitoring.
Safety Management
Safety Management
Manage adverse events, reporting workflows, and safety databases with global clinical rigor.
Clinical Data Management
Clinical Data Management
Build, manage, clean, and reconcile trial data for reliable, audit-ready outputs.
Biostatistics and Medical Writing
Biostatistics and Medical Writing
Turn study data into clear analysis, reporting, and documentation that move programs forward.
Optimizing Preclinical Studies for Clinical Trials and Market Adoption
Too many sponsors and their selected preclinical partners treat a GLP safety study as the last regulatory hurdle before clinical trials. The best preclinical programs do more than satisfy a submission requirement. They also affirm that risks associated with investigator satisfaction, trial site enrollment, and market adoption have been mitigated to the fullest extent possible.
That difference matters.
Jennifer Gordon and Genice Gallegos explain what preclinical work should uncover to the benefit of investigators, site enrollment and post-market adoption.
What FDA’s 2025 Update Means for Medical Device Companies
On December 15, 2025, the U.S. FDA "...removed a barrier to real-world evidence (RWE) in medical device submission. In its updated guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” The agency policy position is now to accept RWE without always requiring submission of identifiable individual patient-level data from real-world data (RWD) sources. This change unlocked broader use of de-identified, large-scale registries, claims databases and electronic health record (EHR) networks to support a wide range of regulatory strategies and applications.
Tracy Case and Pablo Morales, MD, explain the changes to help you understand the options and opportunities.
.jpg)
The ISO 14155 Update Is Here: Top 3 Medical Device Insights
In January 2026, the European Commission published Implementing Decision (EU) 2026/193, formally harmonizing the EN ISO 14155:2020/A11:2024 standard for clinical investigations with the EU Medical Devices Regulation (MDR).
Since the MDR entered into force, ISO 14155 has not been formally harmonized until now. This creates an unusual situation in which a long-waited harmonized standard will be canceled and replaced just days or weeks after achieving harmonization.
As a member of the ISO/TC 194 working group that developed this revision, and a participant in the development of the previous edition (ISO 14155:2020), author Sofia Spjuth had a front-row seat to the discussions that shaped these changes. Here are three things you need to know.
