Community Pharmacies Can Help Bridge the Diversity Gap
Through grassroots patient education, local pharmacies serve as a pivotal doorway to improving access to trials.
Helping Rescued Adjudication Committees Get Back on Track
Determining if an EAC is at risk and key actions to mitigate trial impact.
How to Rescue ‘Failed’ Clinical Trials and Minimize Risks
Strategies for intervention—or, ideally, averting potential pitfalls from the onset.
Harnessing the Power of Scientific Surveillance
Statistical methods used via this technique in centralized monitoring.
Data Standards and ePRO Systems: A Road Less Travelled?
CDISC standards applicable to ePRO and other types of eCOA are still behind in the current regulatory landscape.
Raising its Profile: The Changing Practice of Pharmacovigilance
PV is on the road to becoming a leader, not a follower, in leveraging drug lifecycle information for clinical trials and to inform clinical care.
Pharmacovigilance vs. Drug Safety
Identifying key differences between PV and drug safety.
Filling the Gaps in European Clinical Trial Reporting
The hopes for increased transparency in clinical research beginning to take shape as sponsors get up to speed with new reporting obligations.
Kudos and Hurdles in Tackling Rare Diseases
The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.
