Clinical Operations & Strategy

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.

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.

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.

Webinar Date/Time: Thursday, November 21st, 2024 at 11am EST | 8am PST | 4pm GMT | 5pm CET

For advancement, pharma must focus on streamlining clinical operations.

Webinar Date/Time: Tuesday, January 21st, 2025 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Webinar Date/Time: Thu, Oct 24, 2024 1:00 PM EDT

Webinar Date/Time: Wed, Oct 23, 2024 11:00 AM EDT

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the potential for artificial intelligence in clinical trial decision-making and enrollment.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, director, clinical operations, Rho, offers her thoughts on key considerations that sponsors should be mindful of during the decision-making process with the timeline of a clinical trial.

The presentation expresses the importance of putting the patient at the center of patient recruitment.

Webinar Date/Time: Wednesday, September 25th, 2024 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST

Webinar Date/Time: Thursday, September 19th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST