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Inside ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive T-Cell Malignancies

ImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for agressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.

GUEST COLUMNISTS

The Cost And ROI Of Agentic AI In Clinical Trials: What Sponsors And CROs Need To Know
Beroe Inc. analyst T.G. Prasanna discusses agentic AI for clinical research and how it must be evaluated as a regulated operating cost transformation, with platform, orchestration, compliance, validation, and oversight costs modeled together.
Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over Volume
TransCelerate BioPharma members Ashlin Dunne, Anne Marie Inglis, and Ann Katrine Miranda assess the state of site training, examine how training affects trial execution, and discuss a better path forward.
Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
CuraCell Head of Clinical Operations Torbjörn Ström discusses, in the context of CC-38 and CytoPLY-derived tumor-infiltrating lymphocytes (TILs), the utility of named-patient experience, dosing and preconditioning, and T-cell therapy capabilities in cold solid tumors.
What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory Confidence
Pistoia Alliance President Becky Upton, Ph.D., reviews findings from a poll about AI use in clinical research conducted at Clinical Trials Technology Congress (CTTC) that revealed barriers to adoption, early ROI, emerging use cases, and the role of patient-generated data.
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.
The Promise Of Bispecifics In The Quest For Outpatient Immunotherapy
START San Antonio's Drew Rasco, MD, reflects on the evolution of immunotherapy and highlights how novel therapies such as bispecifics are both challenging and intriguing for principal investigators (PIs).
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.
5 Informed Consent Fixes For Sponsors And Investigators
Informed consent has never been solely about documentation, but some sponsors has treated it as a checkbox exercise. Here, consultant Tasha Mohseni shares tips and fixs for how best to approach informed consent.

CLINICAL TRIAL WHITE PAPERS

UK Clinical Trial Regulations Reform
UK trial regulations have been overhauled. Learn what faster approval pathways, stricter publication rules, and longer retention requirements mean for your operations.

Implications Of Assessing Overall Survival In Oncology Studies
3/25/2026

New oncology standards mandate pre-specified survival analysis to catch long-term harm. Learn how to implement hazard ratio thresholds and the ICH E9(R1) framework for global compliance.
Five Preventable Clinical Design Pitfalls And How To Avoid Them
7/21/2026

While late-stage trial attrition is often attributed to inadequate safety or efficacy, the true failure may be insufficient upstream planning and/or misalignment between clinical and commercial goals.
A New Approach To Dynamic Clinical Oversight With Centralized Insights
7/10/2025

RBQM is transforming clinical trial oversight. By automating protocol digitalization, site selection, and risk assessments 360° Monitoring enables the proactive identification of CtQ factors.
A Guide to Digital Endpoints in Respiratory Diseases
4/15/2025

Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
De-Risking The Neurology IND: Lessons From Early FDA Engagement
5/27/2026

Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia
4/11/2025

Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.
Automated Trial Monitoring Workflows Make A Lean Team More Efficient
1/7/2026

A pharmaceutical therapy developer was looking to automate reports, confirmation letters, and follow-up letters. See what happened when they adopted a cloud-based solution for end-to-end trial management.
Phase 1 Trial In Painful Diabetic Peripheral Neuropathy
2/24/2026

A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.
A Mission To Expand Recruitment Territory
6/11/2026

Learn how a proactive feasibility approach helps sponsors strengthen enrollment forecasting, mitigate risk, and implement timely interventions that improve study execution and clinical development.
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.
Advancing Dose Escalation Strategies With Bayesian Modeling
8/12/2025

A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

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.

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.
5 Informed Consent Fixes For Sponsors And Investigators

Informed consent has never been solely about documentation, but some sponsors has treated it as a checkbox exercise. Here, consultant Tasha Mohseni shares tips and fixs for how best to approach informed consent.

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.