Clinical Operations & Strategy

Behind-the-scenes look at vaccine development.

Compression between phases to accelerate cycle time.

Assessing the opportunities, considerations and implications of decentralized trials—and why they’re here to stay

The pandemic spurred an urgency to innovate that improved clinical development in ways that should benefit the industry beyond COVID-19.

Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.

Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.

Applying a year's worth of lessons to next generation clinical trials.

A top-down analysis of the decentralized trial model’s benefits and impact on the industry.

Operational and patient burden considerations for self-collection of blood specimens in clinical trials

Life sciences companies challenged by need to minimize health risks without sacrificing data quality during pandemic.

Non-profit biotech organization Cure Rare Disease utilizes collaboration amidst COVID-19 pandemic to catalyze speed of therapeutic research.

COVID-19 speeds up clinical research and creates new advancements within industry.

Clinical operations professionals, burdened by lack of data standardization, turn to technology in hopes of streamlining regulatory processes for the future.

The fear of exposure to SARS-CoV-2 in healthcare settings has deterred people from seeking care for non-COVID-19 diseases. One solution to patient care and biomedical research disruptions is implementing remote solutions for conducting research and collecting samples.

Craig Serra, who works in Clinical Technology and Innovation at Novartis, discusses his perspectives on clinical innovation implementation during COVID.

A discussion of various topics amongst TMF experts from Questex’s 2020 Global TMF Summit.

A discussion of how sponsors, CROs, and sites are adapting their operational models to maintain patient safety, data quality, and integrity in the COVID-19 pandemic.

Roundtable explores relationships, outsourcing, risk-based monitoring, and site performance.

The very first article ACT ever published shows how many changes the CRO industry has seen in 13 years.

Well-planned studies designed to pinpoint additional data are increasingly important as a result of the EU's emphasis on added therapeutic value.

A new, standard-based approach minimizes the delays between discovery of innovative agents and identification of their therapeutic benefit for patients-critical in cancer research.

Central call centers can relieve sites of tedious scheduling and record keeping, freeing them to focus on physical exams and other core tasks.

Subject safety in clinical trials has received much recent media attention, most publicly because of the death of a young man during a gene therapy study at the University of Pennsylvania.1 Some large and important clinical trials have been halted before their planned conclusions for safety and other concerns (for example, the Women's Health Initiative).2