Maintaining Data & Reporting Integrity with Mobile Health
As the COVID-19 pandemic has forced a shift toward remote modalities, mobile health (mHealth) technologies have been on the rise. […]
Reporting Requirements
Encouraging Site Centricity and Collaboration at Onsemble
During the week of October 5-8, more than 1,700 Advarra technology customers gathered virtually for the Fall Onsemble Conference. A
The Importance of Keeping DSMBs Independent
Establishing DSMB independence helps mitigate bias, ensuring clinical trials adhere to regulatory standards and build public trust.
IRB Review of Phase I Research: Balancing Ethics and Efficiency
Phase I research demands careful IRB oversight, balancing participant safety with timely reviews. Proactive strategies can help address its unique challenges.
Understanding eSource, ePRO, and EDC
eSource, ePRO, and EDC each play distinct roles in clinical trials, enhancing data consistency, participant experience, and overall study efficiency through technology integration.
Beginner’s Guide to Minimal Risk Research
When an institutional review board (IRB) determines research is “minimal risk” (as defined in Department of Health and Human Services
Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)
Read about IND safety reporting required under FDA 21 CFR 312.32(c), challenges faced in adhering to the regulation, and strategies to ensure compliance.
Site-Driven Metrics: Operational Data To Improve Research
The true value of metrics is to measure operational performance in order to improve internal processes. In clinical research, this is highly beneficial when applied where the work is conducted: at the sites.
Q&A from Remote Monitoring: Study Compliance In A Changing World
In a recent webinar, Advarra experts Emily Eldh and Ben Shankle provided insights and information in Remote Monitoring: Study Compliance
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug
Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
To maintain Part 11 compliance, research sites must validate electronic systems storing FDA-regulated records, safeguarding data integrity and accuracy.
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
In a recent webinar, Advarra experts Constance Cullity and Michele Russell-Einhorn presented FDA Inspections of Clinical Investigators: Understanding the Process