Regulatory

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), highlights how research communities have self-organized in light of recent changes.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses how companies in the clinical research industry have been responding to recent political headwinds.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses how the current political climate is affecting diversity in clinical research and how diversity action plans may be impacted.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), shares his thoughts on the recent funding cuts made by the NIH and how they are impacting medical research.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, talks innovation in clinical technology and how the FDA can continue to promote its adoption.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, discusses the need for change in the clinical research industry and how the adoption of new technology can increase operational efficiency.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, shares his thoughts on the current climate of clinical research following NIH funding cuts and the removal of FDA diversity guidelines.

Webinar Date/Time: Tuesday, April 1, 2025 at 11:00 AM EST

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, talks FDA’s latest protocol deviation guidance and potential changes to the draft.

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, highlights FDA’s recent protocol deviations guidance and how it reinforces previous recommendations from industry.

In this video interview, Pomerantseva, director of product management, RBQM, eClinical Solutions, discusses the new guidance and its level of detail on the different types of protocol deviations.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Rajneesh Patil, vice president, digital innovation, IQVIA, highlights the impact of artificial intelligence/machine learning in improving outcomes and maintaining safety with its implementation.

Recent actions by the FDA and NIH in response to the current political climate have left key stakeholders in clinical trials with limited resources to conduct equitable research.

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

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, talks protocol submission formats and how data interoperability can support artificial intelligence.

Study finds the typical cost of clinical research for developing new drugs is lower than previously estimated, with median costs providing a more accurate reflection than mean costs.

Unlocking the full potential of artificial intelligence requires these stakeholders to ensure their data are accessible and secure.

Support from these partners can aid drug and medical device developers in keeping up with the evolving regulatory landscape.

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, discusses the importance of goal setting in the context of FDA’s latest Diversity Action Plan guidance.

In this video interview, Mark Melton, vice president of biospecimen data and operations, Slope, highlights the clinical research industry’s need for more regulation around collecting data.

In this video interview, Rebecca Metcalfe, principal scientist, patient-centered research, Core Clinical Sciences, highlights the consequences of focusing solely on enrollment targets.

Moving towards the development of mature quality management systems.

In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, share their reactions to the FDA releasing its Diversity Action Plan Guidance.

In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, discuss a recent article they authored on the guidance.

Industry leaders share their perspectives on the guidance and how it will affect sponsors moving forward.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how the guidance should prompt better-designed oncology trials and greater diversity.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how sponsors will need to plan ahead even further for their oncology trials.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.

In this video interview with ACT editor Andy Studna, Kashoki, SVP, global head of regulatory strategy, discusses the new draft guidance and its emphasis on proactive planning.