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Reimagining Data Governance For The AI Era

Understand the persistent governance challenges that undermine AI initiatives and walk away with a robust blueprint for building a resilient, scalable, and ethically sound framework.

GUEST COLUMNISTS

Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center
For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.
Reminder: FDA Approval Is Not Synonymous With Commercial Success
Life sciences expert Rena Roseberg, Ph.D., warns that research and commercial efforts cannot operate within a vacuum. Here, she shares best practices on developing a therapeutic product with solid understanding of its commercial viability.
What Sites, Sponsors, Vendors, And CROs Can All Agree On
Experts representing sponsors, sites, vendors, and CROS discussed at Life Sciences Future SW the pain points and the opportunities that lie ahead in clinical research.
AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research
Companies that successfully use AI are those that understand technology magnifies accountability. Anyone that fails to internalize that lesson could find themselves defending the very systems they relied on to bring those products to market.
Is It Time To Replace RECIST — Or Just Add AI?
Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.
India Opens The Fast Lane For Drug Development
New in 2026, extensive reforms to India’s clinical trial rules are slashing approval timelines in half and eliminating licenses that once took months to obtain.
U.S. Pharma Tariffs And MFN Become Law After April 2 Update
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens
Patient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.

CLINICAL TRIAL WHITE PAPERS

Completed Clinical Trials, Terminations Both Rose In 2023
This white paper highlights how the widespread growth in completed trials is coupled with higher success rates across multiple therapeutic areas, signaling the end of pandemic-related disruptions and infectious disease-related activity after three years of fluctuations.

Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?
10/20/2025

Noncompliance with clinical trial disclosure regulations can jeopardize M&A deals. Understanding FDA and SEC requirements is critical to avoid red flags during due diligence.
The Complexities Of Effective Patient Retention In Clinical Trials
11/7/2025

Identifying and enrolling the right-fit patients from the outset is essential, but so is implementing comprehensive retention strategies that prioritize patient comfort, trust, and ongoing engagement.
Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape
9/1/2025

Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.
Disclosure Management System: Build Or Buy?
6/19/2025

Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
A New Era Of ADC Development Demands A New Kind Of Partner
3/30/2026

Explore how to navigate the evolution of antibody-drug conjugates by mastering AI-driven selection, dose optimization, and new regulatory strategies for earlier-line clinical success.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Leading Recruitment With A Strong Alzheimer's Referral Pool
2/24/2026

A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.
Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments
1/15/2025

Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot
8/19/2024

Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.
FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study
3/12/2026

Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.
GSK And Medable Discuss The Next Phase Of DCTs
3/10/2025

GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.
Biotech Delivers A Superior Patient And Site Experience
3/4/2025

To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

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RECRUITMENT AND DIVERSITY

This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.

Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials

Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)

In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)

Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.

FOCUS ON PATIENTS

Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials

Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
The Patient-Centered Trial Paradigm For Knee Osteoarthritis

Although PROs can complicate a trial design, they're essential to reflecting a patient’s true knee OA experience and producing meaningful evidence, explains Katie Mowry, Ph.D., VP of R&D at Organogensis.
Caregivers: The Missing Line Item In Trial Budgets

More than 60 million Americans are caregivers, holding up a system and clinical research enterprise, yet they are mostly uncompensated for their efforts. That needs to change, says Denise N. Bronner and Marsha Calloway-Campbell.