Clinical Operations & Strategy

Overcoming the illusion of knowledge in clinical research can enhance decision-making, training, and project success—helping ensure trials run smoothly and effectively.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses how key stakeholders in clinical research are responding to uncertainty with budget cuts and administrative shifts.

As stakeholders debate fair market value in clinical trial budgeting, a new task force works to align sponsors, CROs, and sites on transparency, sustainability, and efficiency.

Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.

In this video interview, Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines.

As biotech innovation accelerates, the clinical research workforce is rapidly eroding—threatening the future of drug development. From workforce burnout to training program cuts and talent pipeline collapse, clinical trial professionals must confront this escalating crisis head-on to sustain progress and protect public health.

A blend of FSO and FSP models in the landscape of artificial intelligence can ensure CROs stay up to date with the unique demands of industry.

Improving access while maintaining a high level of research.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, discusses how these cuts are impacting critical areas of clinical research such as staffing and patient access.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, discusses how clinical operations professionals should be focusing on flexibility, behavioral visibility, and communication in the current landscape of managing vaccine trials.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses how risk-based approaches must be prioritized amidst the increased demand for quality and compliance.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, highlights recent ICH guidelines and how risk should be an area of focus as trial designs continue to get more complex.

Strategies for ensuring that innovation with PROs remains parallel with advancements in disease detection and progression.

Examining the implications of the recent US executive orders concerning diversity, equity, and inclusion pursuits—and the key questions each clinical trial stakeholder must now navigate.

The future of clinical trial design involves incorporating the patient experience into strategic asset planning.

Anticipating divestment, reallocation of investments, and retrenchment.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, talks the current landscape of sustainability in clinical trials and how stakeholders are beginning to pay more attention to carbon footprint amid increasing protocol complexity.

Why investing in truly effective training from the outset can pay off exponentially for clinical teams—and serve as a strategic advantage.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses numerous themes that clin ops can focus on to keep its trials running efficiently and effectively.

In this video interview, Cameron Breze, product manager, Inovalon, talks clinical technology and how the industry is working to increase comfortability with its implementation.

In this video interview, Dominique Demolle, CEO of Cognivia, discusses how understanding the patient journey from the very beginning of a study can help mitigate risk and improve patient centricity.

In this video interview, Dominique Demolle, CEO of Cognivia, talks artificial intelligence/machine learning and its potential in gathering patient data.

With an increased need for operational efficiency, while also leveraging new technologies such as AI, the landscape of clinical operations is evolving, as our February issue explores.

Examining those technology-supported areas that sponsors, CROs, and sites consider the most valuable.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Jonathan Norman, director, localization services, YPrime, discusses the importance of communicating with patients in their native languages.