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How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy

Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.

GUEST COLUMNISTS

How Visible Is Your Clinical Trial To AI?
Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.
Threat From Within: Why Biopharma's Drug Development Bottleneck Is Systemic
As FDA timelines and AI-enabled development accelerate, biopharma’s biggest bottleneck may be its own ability to make earlier, cross-functional decisions.
Beyond Task Tracking: Why ClinOps Needs Dependency Intelligence
Clinical trial operations will always need task tracking, but they're not enough on their own. Dependency intelligence shifts the focus toward readiness not reaction.
To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures
UNC researcher Irena Dujmovic Basuroski, MD, Ph.D., discusses why transverse myelitis remains difficult to study, how multicenter collaboration and adaptive trial designs may help, and why better clinical, patient-reported, and biomarker-based measures are essential to advancing treatment.
From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams
AbbVie's Svetlana Kobina discusses how basket trials can help clinical development teams move from early clinical signals to a more disciplined strategy.
4 Hidden Gaps In Clinical Trial Preparation For Small Biotechs
Gaps are not always visible at the executive level, but their consequences are very real — affecting timelines, budgets, data quality, and ultimately the likelihood of regulatory success.
ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies
ImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for aggressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.
Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy
With the help of Beroe Inc.'s Surya Ponnam, discover how per-patient cost (PPC) analytics is evolving into a core capability for balancing cost, quality, speed, and patient outcomes.

CLINICAL TRIAL WHITE PAPERS

Disclosure Management System: Build Or Buy?
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.

Digital Endpoint Resource Guide: Sleep Disorders
12/10/2025

Sensor-driven digital endpoints track sleep patterns and disruptions, standardize trial outcomes, and enable remote monitoring that reduces patient burden while improving treatment-response insights.
Eliminate Clinical Trial White Space With The Right AI Strategy
10/9/2025

Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.
Beyond The Benchmark: Innovative Trial Designs Transform Research
1/15/2026

Adaptive designs, decentralized models, and AI insights are reshaping trials — boosting efficiency, speeding timelines, and strengthening evidence amid evolving regulations and funding pressures.
Combination Therapy Dose Optimization In Oncology Trials
3/30/2026

Optimize dose selection in oncology trials by moving beyond toxicity limits. Use advanced modeling and benefit-risk analysis to improve efficacy and meet modern regulatory standards.
The Renaissance Of Psychedelic Research: History, Protocols, And Forward Trajectories
7/30/2026

Discover how clinical trial protocols are evolving to address unblinding, therapeutic support variables, and regulatory standards in modern psychedelic research.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Expand Bandwidth With A Trusted Regulatory Writing Partner
9/18/2025

Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.
Supporting Study Set Up In Just 4 To 6 Weeks
3/4/2025

Facing challenges in cycle times, quality control, and visibility, a global CRO adopted Medidata’s Rave Imaging, integrating it with its existing Rave EDC system to create a seamless digital workflow.
Reducing The Burden Of Patient Retention And Improving Continuity
1/6/2026

Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.
Optimizing EDC Strategy And Data Collection for a Rare Disease Trial
6/11/2025

Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.
Optimizing Clinical Supply Management With A One-Team Approach
7/15/2026

See how NewAmsterdam Pharma managed 11 global studies across 51 countries and 835 sites for 12,000+ patients without overwhelming their internal team.
Use Case: How Consulting & Analytics Can Guide Clinical Strategy
7/10/2025

A large European pharmaceutical company sought to benchmark a CRO’s suggestions involving a Phase III trial for a newly acquired asset.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

More Newsletters

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.

How Visible Is Your Clinical Trial To AI?

Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.
Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies

Protocol complexity directly affects timelines, costs, and execution quality. Consultant Jessica Cordes explains why this challenge requires sponsors to change their approach to protocol design, feasibility, and start-up.
Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials

Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.

FOCUS ON PATIENTS

Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials

Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
Digital Twins Enhance Disease Progression Measurements In FSHD

Digital twins can transform trial design by making data more robust and alleviating patient burden. In this interview, Epicrispr CEO Amber Salzman, Ph.D., shares how the company's using it to reliably predict muscle volume change in their trial for a FSHD gene therapy.
How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients

Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.