Newsletter | February 20, 2025

02.20.25 -- Input Needed On Using AI To Create Lay Summaries Of Trial Results

SPONSOR

Webinar: Who’s In Charge of Your Trial? How to Ensure Effective Oversight and Leadership

Clinical trials in complex therapeutic areas require more than just a solid strategy—they demand proactive and engaged operational leadership from the sponsor side. Join our expert panel to discuss how an active and knowledgeable Clin Ops lead, in collaboration with an experienced outsourcing project lead, can drive informed decision-making, enhance efficiency, and ultimately ensure trial success. Click to learn more.

REGULATORY & COMPLIANCE

Input Needed On Using AI To Create Lay Summaries Of Trial Results

Guest Column | By Behtash Bahador, MS, and Kim Edwards, Ph.D., CISCRP

CISCRP is soliciting feedback from research professionals, patients, and advocacy groups on its "Considerations for Using AI to Create Lay Summaries of Trial Results" until Feb. 18.

Navigating The European Market's Regulatory Complexities

White Paper | By Swapnil Pokharkar, Cristina Blanco Fernández, Ankit Tyagi, and Joanna Szmidt, IQVIA Safety & Regulatory Compliance

Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.

Accessing Unapproved Therapeutic Modalities In The USA And Australia

Article | By Gabriel Kremmidiotis and Alex Kavros, Avance Clinical

Learn about the regulatory frameworks developed by the United States and Australia to provide access to unapproved therapies for patients with serious or life-threatening conditions.

Successful Preparation Strategies For NDA/MAA Marketing Applications

White Paper | Martha Plaza, M.B.A. and Kimberly Newton, M.A., Veristat, Inc.

No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. Learn the key strategies that can be implemented to propel even the most complex submissions to successful regulatory conclusions.

Tips And Tricks For Developing Rare Cancer Clinical Trials

Article | Ergomed Clinical Research

Conducting clinical trials for rare cancers presents unique challenges, making a partnership with an experienced Oncology CRO crucial for overcoming hurdles and ensuring trial success.

Regulatory Special Designations

Brochure | Halloran Consulting

Discover how securing an FDA special designation can accelerate your drug development process and bring life-saving therapies to market faster.

SPONSOR

What’s the real impact of the "one-and-done PI" in clinical trials? Some say it’s a major issue, while others question if it’s a concern at all. Clinical Leader Live’s expert panel—backed by research—dives into the data, debate, and potential solutions. Join this free digital event!

OUTSOURCING MODELS

How PDS Biotech Approached FDA Meetings For Its Phase 3 Cancer Trial

Guest Column | A conversation with PDS Biotech Kirk Shepard, MD

PDS Biotech CMO Kirk Shepard reveals his team’s interactions with the FDA as it sought to begin its Phase 3 trial for the treatment of HPV-positive recurrent and/or metastatic head and neck squamous cell carcinoma.

Streamlining Early-Phase Oncology Study Start-Ups

White Paper | TFS HealthScience

Explore the significance of targeted therapies and adaptive trial designs that prioritize patient-specific characteristics.

Executive Q&A With SGS' Hudson, NH Bioanalytical Services Facility

Q&A | By Sujata (Suzzy) Bhavekar, M.S., SGS

Explore how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

Collaborating To Support Customers From Discovery To Clinical

Article | By Eleanor Row and Russell Scammell, Quotient Sciences

Charles River and Quotient Sciences' collaboration offers an integrated approach designed to remove obstacles and reduce timelines.

PCI Pharma Services ESG Report

Brochure | PCI Pharma Services

Review PCI's commitment to environmental and social responsibility, including its ambitious sustainability goals and achievements across various categories.

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  • Clinical Trial Technology (Tuesday)
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