Topic

Articles

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.

Small Biopharma and CROs: Seeking Stronger Synergies

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

How Does FSP Models Complement eSource Implementation?

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

A Competency-Based Approach to Combating the Talent Wars in BioPharma

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.

New Research Emerges to Challenge Steep Costs of Clinical Trials

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

CRO Oversight Roundtable

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

CROs Tackle Neurodegenerative Disease Studies

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.

Janssen Advances Efficiency and Effectiveness in CRO Oversight Model

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.

CRO/Sponsor