Clinical Operations & Strategy

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

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.

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.

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, 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.

Leveraging and benchmarking insights to boost efficiency and optimization.

The key considerations for sponsors in deciding whether to claim the credit.

Tips and best practices for empowering professionals to become change agents in their institutions, including clinical trials.

Clinical trial liaisons rather serve as experts in their therapeutic areas and as clinical trial specialists to provide a suite of strategic advantages to benefit a study.

In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, highlights how the MMRF accelerates trial timelines for biopharmas by integrating an adaptive platform model.

In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, discusses how MMRF goes beyond safety and efficacy data to help biopharmas research appropriate dosing for multiple myeloma therapies.

In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, talks unmet need in the multiple myeloma space and how the Horizon trial is addressing complexity in treatment regimens.

In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, highlights the design of Horizon, an adaptative platform trial for the treatment of multiple myeloma.

In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discusses the greatest challenges with clinical trials in multiple myeloma and how MMRF is aiming to address them.

In this video interview, Dipanwita Das, CEO & co-founder at Sorcero, highlights trial startup timelines and workforce development as key areas of focus for clinical operations professionals in 2025.

Use of decentralized approach in a Phase 1 pharmacokinetic trial shows the ability to enable remote data collection and monitoring, which could improve patient access and enhance the efficiency of clinical research.

How biopharmas are advancing their pharmacovigilance operations.

In this video interview, Dipanwita Das, CEO & co-founder at Sorcero, discusses challenges such as high costs and long timelines in executing clinical trials.

Phase III HELIOS-B trial found that Amvuttra (vutrisiran) also preserved functional capacity and quality of life in patients with transthyretin amyloidosis with cardiomyopathy.

Webinar Date/Time: Tuesday, February 11th, 2025 at 11am EST|8am PST|4pm GMT|5pm CET

Semaglutide 7.2 mg significantly outperformed semaglutide 2.4 mg and placebo with a 20.7% average reduction in weight and a comparable safety and tolerability profile, further establishing its efficacy in obesity treatment.