Regulatory

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, makes the case that governance and quality must be built into every stage of the trial life cycle—not enforced at database lock or submission—and what that requires from teams and technology.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, explains why the FDA's push toward continuous data review exposes the fragmentation at the heart of current clinical trial infrastructure and what unified data pipelines need to look like to make it possible.

From rising costs and regulatory uncertainty to persistent vaccine hesitancy, sponsors face mounting pressure to standardize operations, build community trust, and develop the behavioral capabilities needed to run vaccine trials effectively in a rapidly shifting environment.

Real-world evidence is shifting from a post-market footnote to a concurrent validation layer running alongside trial data, requiring organizations to build unified data environments that integrate EHRs, claims, and patient-reported outcomes on an ongoing basis rather than retrospectively.

Despite clear data quality and regulatory advantages, paper-based clinical outcome assessments persist due to cost asymmetry, trial complexity, startup timelines, and provider capability gaps, though hidden paper costs and loss of institutional knowledge often outweigh upfront electronic implementation expenses.

In this Q&A, Adrelia Allen, executive director of clinical trial patient diversity at Merck, discusses how the company is embedding diversity into clinical trial execution—from protocol design and site selection to long-term community engagement that extends well beyond individual trial timelines.

The CNPV program has compressed drug review timelines to as little as one to two months for qualifying sponsors, but succeeding under that pressure requires a fundamental rethink of how development teams plan, communicate, and execute.

Clinical Trials Day is an international celebration of everyone who makes medical discoveries possible. It is also an opportunity to shine a light on the innovations helping to keep research rising.

Webinar Date/Time: Thursday, June 4th, 2026 at 11am EDT|8am PDT|4pm BST|5pm CEST

FDA Commissioner Marty Makary’s departure caps a turbulent tenure marked by leadership instability, industry pushback, and a series of regulatory controversies that complicated drug development for sponsors and CROs.

As imaging-heavy clinical trials grow more complex and globally distributed, sponsors are increasingly re-evaluating traditional infrastructure models, with cloud-native platforms showing potential to reduce operational burden, accelerate site activation, improve imaging quality oversight, and lower total trial costs.

Zentails announced the first dosage of Azenosertib administered in its phase III Aspenova trial to test azenosertib vs chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer.

FDA clears Cellenkos’ IND for CK0802, enabling a mid-stage trial in steroid-refractory GVHD.

In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, traces how small documentation errors move through a fragmented supply chain and ultimately erode the trust that patients and regulators depend on.

FDA gives granted accelerated approval to lunsotogene parvec (Otarmeni) for OTOF-related sensorineural hearing loss based on early CHORD trial results in children.

In this Q&A, Mwango Kashoki, MD, MPH, SVP and global head of regulatory strategy at Parexel, breaks down the FDA's plausible mechanism framework and what it means for sponsors developing individualized therapies in ultra-rare disease settings.

The execution translation gap—the failure to convert identified problems into coordinated, timely action—costs millions per trial through delayed amendments, persistent deviations, and slow site activation, yet remains addressable through aligned accountability and proactive execution management.

In this Q&A, Jenna DiRito, PhD, COO and co-founder of Revalia Bio, discusses how earlier, human-relevant data is reshaping go/no-go decision-making in drug development and what a truly front-loaded workflow looks like in practice.

Agency outreach targets a compliance gap affecting thousands of registered trials, with nearly 30% of studies subject to mandatory reporting showing no results submitted to ClinicalTrials.gov.

In part 3 of this three-part series, behavioral science reveals that clinical trial diversity cannot be achieved through last-minute recruitment efforts, but requires designing protocols, sites, and enrollment strategies around the real barriers and needs of underrepresented communities from the outset.

Risk-based monitoring requires integrated data systems, validated analytics, and strong governance to work effectively across global trials, but sponsors face significant technical and operational challenges that demand strategic solutions and organizational alignment.

The administration's latest budget proposal seeks sweeping reductions to federal health research funding, including the elimination of several NIH institutes and centers.

Real-world data is increasingly used to optimize trial design, reduce recruitment burden, and support regulatory decisions, but adoption remains uneven due to challenges around data quality, integration, and internal alignment across functional areas.