Topic

Articles

The drug development sector is embracing technologies and digital methods that were previously not as widely used due to the COVID-19 global health crisis. 

Anticipating Digital Transformation of the Drug Development Workforce

Nearing a year into the pandemic, this article describes the legal concerns CRM encountered during the COVID-19 outbreak.

Legal Perspectives on Conducting Clinical Trials During COVID-19 Outbreak in Malaysia 

The success of a clinical study depends on the possibilities to involve the patient in the study. 

Rate of Patient Recruitment to International Multicenter Clinical Studies in Eastern Europe Countries

FDA’s Vaccines and Related Biological Products Advisory Committee addresses issues related to testing and approval of potential COVID vaccines.

Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors

Findings from a Tufts study examining the effects of COVID-19 on clinical trials.

COVID-19 and Its Impact on the Future of Clinical Trial Execution

Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success. 

Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World

Evaluating the lessons learned about trial sites from COVID-19 to form new strategies and improve patient safety for the future.

Shifting Perspectives on Site Networks to Create Positive Change

It's almost impossible to map out study budgets with absolute precision. Planning for the unexpected costs, such as those associated with slow enrollment, protocol amendments, and other contingencies—is vital.

Key Cost Drivers in Clinical Research: Guide to Successful Budgeting

To optimize the Sponsor/CRO relationship, the final proposal must represent a win for both parties.

Clear Scope of Work Specifications Makes for Strong CRO/Sponsor Partnerships

A discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia. 