Clinical Operations & Strategy

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.

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, 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.

A focus on data and process excellence advances product development.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, discusses historical challenges with long protocol development timelines and how they can be addressed.

Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.

This model, built around a mix of flexible, empathetic, and results-driven principles, may be uniquely positioned to navigate the changing dynamics and demands for contract development and manufacturing organizations.

By using engaging visuals, researchers and companies can better communicate complex concepts, increase trial participation, and foster public trust in science.

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discusses how some stakeholders view DCTs only as fully remote trials.

Recommending two enlightening books to introduce the science of thinking, learning, and doing for clinical research professionals.

Webinar Date/Time: Wed, Jan 22, 2025 11:00 AM EST

Palmese, executive director, site relationships and DCT solutions, discusses the practice of incorporating decentralized elements in a study rather than planning a decentralized trial from the start.

The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.

The current lack of clinical trial professionals is a serious concern that's compromising the ability to conduct high-quality clinical trials, but it's not irreversible.

As studies become more complex, stakeholders must be aware of the resources they are utilizing and their impact on the environment.

In a fireside chat with ACT editor Andy Studna, Bowdish, from a clinical research cancer center, shares her experience with these relationships and how to streamline clinical operations.

Use case explores the arrangement’s effectiveness in the biometrics setting.