CRO/Sponsor

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

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

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

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

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

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

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.

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

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

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.

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

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

Biometric functional services, more than any other, can have a significant impact through the standardization of data collection and management.

Creative approaches are needed to address the clinical research workforce “talent wars”

The Institute for Safe Medication Practices has released a new study which breaks down the estimated costs associated with the approval of new pharmaceutical treatments.

Excerpts resulting from the extended discussion on CRO oversight at the recent CBI Finance and Accounting for Bioscience Companies conference.

In this interview, Linda Rawlings, VP of Neurodegenerative Development at Synteract, elaborates on addressing the challenges of neurodegenerative disease clinical trials.

Joe Pollarine, Head of GxP Systems Strategy Director at Janssen, recently spoke about CRO oversight models and will expand on these models in this interview.

As the size, complexity, duration, cost, and globalization of clinical trials has grown, pharmaceutical and biotech companies have moved to outsource clinical activities to CROs to achieve a wide range of objectives.

There are key cultural differences to be aware of before conducting clinical trials in Japan.

Proposed partnership model explores the value of establishing alliances between CROs and networks of small and emerging biopharma companies.

Exploring sourcing model options for appropriate incorporation of DMCs into a clinical program.

A two-phase statistical analysis identifies the key performance drivers in clinical trial startup.

MAPs can effectively address unmet patient needs and become a cornerstone of product strategy.

Pharma needs to find a balance in working with Sponsors and CROs in order to streamline the study processes.

Clinical research organizations should look to peer-to-peer mentoring for professional development.

Companies trusting each other and looking out for each other's interests is the hallmark of outsourcing.

The goal is to have an evidence development framework that can answer a range of questions simultaneously.

Oncology clinical trials: A case for Russia and Eastern Europe.