Topic

Articles

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. 

The ICR-CRM-IQVIA Research Network Collaboration Experience

Sudarshan Hebbar, CMO of CalciMedica, reveals how the FDA, ethics committees, and safety consortia have responded to helping to advance the application of novel therapeutics towards COVID.

A Journey: Biotech, FDA, and Safety Committee Responses to COVID 

Industry experts share their thoughts on the evolution of the functional service provider model, as demand for flexible resourcing grows.

The Rise of FSP Outsourcing in Drug Development

Stakes are high for emerging biopharmaceutical companies to get their relationships with CRO partners right from the outset.