Newsletter | May 29, 2025

05.29.25 -- How Close Is The First FDA-Approved Full-Spectrum Botanical Drug For Autism?

SPONSOR

Struggling with patient recruitment? You're not alone. Join Clinical Leader Live on June 5th as we explore proven strategies to overcome enrollment challenges in clinical trials. Hear real-world success stories and learn how smarter tech, data use, and community engagement are helping sponsors, CROs, and sites boost recruitment and avoid costly delays. Secure your seat today!

OUTSOURCING MODELS

How Close Is The First FDA-Approved Full-Spectrum Botanical Drug For Autism?

AJNA BioSciences CEO Joel Stanley details his transition from helping to build one of the largest CBD companies to developing what he hopes will become an FDA-approved botanical drug to treat the symptoms of autism.

Is Your Clinical Research Site GCP-Ready?

By fostering a culture of continuous improvement through internal audits, clinical research sites can identify non-compliance issues and enhance their research practices.

The Future Of Pharmacovigilance: Integrating AI

The use of AI in pharmacovigilance can enhance processes such as data analysis, signal detection, and case management by increasing efficiency, accuracy, and the ability to manage large datasets.

Investigational New Drug Application Support

When faced with industry pressures, companies seek out essential support to ensure their product's market plan is grounded in expert guidance.

REGULATORY & COMPLIANCE

Celebrating Clinical Trials Day, Part 2: Trial Optimization In Action

Celebrate Clinical Trials Day 2025 with these industry experts as they share experiences and advice related to trial design, regulatory and compliance, and outsourcing challenges.

The 3 Cs You Should Expect From Your Pharma Service Provider

We share important factors to consider when weighing your contract service provider options. These “Three Cs” can indicate whether a service provider has the capabilities desired by a drug sponsor.

The Rescue Option: Course Correcting Struggling Clinical Trials

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

Build Vs. Buy Vs. Partner In Life Sciences: Making The Right Call

Discover when life sciences organizations should develop technology in-house, buy off-the-shelf solutions, or form strategic partnerships, exploring the costs and risks that come with each approach.

The Role Of CROs In Drug Development

In the rapidly evolving landscape of drug development, Contract Research Organizations (CROs) play a pivotal role. Learn more about CRO and selecting the right one to partner with.

Your Global CRO Partner In Neuroscience

Leveraging over 140 completed neuroscience studies and specialized knowledge in neurodegenerative diseases, TFS delivers substantial expertise and a demonstrated history of successful trials.

Your Partner In Psychiatry Research

Our extensive network of specialized Healthcare-First psychiatry research sites is dedicated to advancing psychiatric care through cutting-edge clinical studies.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

Learn more about our personalized newsletters here.

Connect With Clinical Leader: