Archives: Resources
Meeting Pregnancy and Lactation Safety Requirements: A Guide for Sponsors
Build a more efficient, compliant, and patient-centered approach to pregnancy and lactation safety studies with expert-backed strategies in this practical guide.
Optimizing your oncology endpoint data collection
Explore key considerations for improving oncology endpoint data collection across imaging, eCOA, connected devices and cardiac safety.
Moving beyond paper: eCOA successfully delivered across three Phase I oncology studies
Discover how at-home eCOA supported participant compliance, data quality and early oncology trial insights across three Phase I studies.
Regulatory guidance for PRO strategy in oncology trials
Explore regulatory considerations for incorporating patient-reported outcomes into oncology trials to support patient-centered evidence.
Standardized imaging and ECG data in Alzheimer’s trials
Discover how standardized MRI, PET and ECG data collection supported evidence generation in a complex global Alzheimer’s disease study.
Optimize cardiac safety in clinical trials with centralized ECG
Explore how centralized ECG data collection improves consistency, safety oversight and regulatory readiness in clinical trials.
Maximizing value in early phase oncology trials
Discover how innovative endpoints in early phase oncology trials support earlier insights across efficacy, safety and patient experience.
Holistic endpoint strategies for obesity trials
Explore how diverse endpoint strategies allow sponsors to assess safety, efficacy and broader health impacts in obesity and GLP-1 trials.
Scientific and regulatory support for biotech trials
Explore how early scientific engagement enables biotechs to optimize trial design, endpoint strategy, data quality and regulatory planning.