Andy Studna, Senior Editor

Intrathecal onasemnogene abeparvovec (OAV101 IT), an investigational, one-time gene replacement therapy, demonstrated a statistically significant improvement in HFMSE in the Phase III STEER study.

In this video interview, Cameron Breze, product manager, Inovalon, highlights current trends with decentralization and how a dual approach can ensure flexibility across different therapeutic areas.

The pivotal Phase III study in myasthenia gravis met its primary endpoint with meaningful improvements in MG-ADL across both higher and lower dose arms.

In this video interview, Cameron Breze, product manager, Inovalon, discusses the need for accurate information in creating useful clinical data.

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

New data from the Phase II RAINFOL-01 study shows rinatabart sesutecan (Rina-S), an investigative antibody-drug conjugate, demonstrated a confirmed objective response rate of 55.6%.

In this video interview, Cameron Breze, product manager, Inovalon, discusses current challenges with patient recruitment and how a combination of technology and manual effort can help improve efficiency.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how newly emerging data from patients can help the industry improve its recruitment strategies.

The combination demonstrated non-inferiority to comparator antiretroviral therapies, meeting the primary efficacy success criterion in both trials.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, talk technology and how it can save time in the recruitment process.

Icotrokinra met all primary endpoints in the studies, demonstrating significant skin clearance and clinical remission.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how industry can improve on truly understanding the unique circumstances of patients.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, address the challenge of patients not being informed of clinical trials by their primary doctors.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, highlight the results and how patients are interested in learning more about clinical trials relevant to their condition.

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.

Tris Pharma’s first-in-class oral dual-NMR agonist achieved its primary endpoint in the ALLEVIATE-2 study by demonstrating a statistically significant and high level of pain reduction compared to placebo.

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, highlights the need for a satellite model in bringing clinical trials to more rural locations.

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.

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.

Policy change by the Trump administration now allows the agency to post public notices in the Federal Register and advertise meetings on scientific research groups.

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, discusses the importance of open dialogue during risk assessments.

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.

Following initial positive results shared by Teva and Sanofi in December 2024, new data shows duvakitug (TEV’574/SAR447189) achieved higher rates of clinical remission compared to placebo in the advanced therapy-experienced subgroup.

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 this video interview, Dipanwita Das, CEO & co-founder, Sorcero; Sujay Jadhav, CEO, Verana Health; and Kimberly Tableman, founder & CEO, ESPERO, highlight areas around clinical data that could have a large impact on the industry in 2025.

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.

In this video interview, Dominique Demolle, CEO of Cognivia, highlights how patient non-adherence can increase trial timelines and incur additional costs.

In this video interview, Dominique Demolle, CEO of Cognivia, discusses challenges that sponsors are currently facing with adherence and some strategies that can help address them.