CRO/Sponsor

Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas.

Proactive, pervasive, and strategic planning lead industry into future.

In this interview, Dave Hanaman, co-founder, president and chief commercial operator at Curavit Clinical Research discusses launching the organization at the start of the pandemic and how it operates with a commitment to designing trials with a fully virtual site.

Strong collaboration critical as trial development advances.

Technology, talent and specialization add up to a plethora of industry M&As.

A move back to in-house management of clinops could be on the horizon for sponsors.

A brief look at the market for mergers and acquisitions since the year of COVID.

New BDO CRO Insights Report reveals high rate of CRA turnover and what organizations are doing to combat it.

Steven Bukvic, CEO of the ACROSS Global Alliance, speaks to Applied Clinical Trials about how it works to improve the clinical trial experience for smaller- and medium-sized sponsors.

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.

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.