11.13.25 -- The Rise Of Specialist CROs In Clinical Outsourcing

Embedding AI governance into an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.

Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.

Explore the FDA's 2024 final guidance on DCTs, including key updates that address previous concerns, affecting healthcare providers, sub-investigators, and sponsors.

Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial data generated outside a U.S. IND, in a New Drug Application (NDA).

Our goal is to support the transition of your development candidate from research and discovery into human clinical trials, with the shared goal of addressing the serious unmet need of patients.

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.

See why building digital, automated infrastructure is essential and better aligns CROs with today's speed, compliance, and innovation needs.

Biases, often hidden, can distort vendor selection decisions. Recognizing and addressing them across individuals and teams leads to more objective, aligned, and successful clinical trial outcomes.

Many U.S. oncology sponsors are expanding their late-phase trials into Asia to secure access to rich patient pools, leverage efficient regulatory pathways, and save time and money in the clinic.

Explore how the optimization of Interactive Response Technologies (IRT) settings relieved the burden of managing global supply needs for a CRO customer and clinical sponsor.

Rethink traditional drug development. The integrated clinic-CDMO model enables on-demand manufacturing, real-time formulation adjustments, and faster decision-making while conserving API.

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

The shifting dynamics of clinical research from the current funding dynamic to the increased complexity of drug development, requires a different approach to functional outsourcing to be successful.

Palleos Oncology™ is a comprehensive solution designed to support pharmaceutical companies throughout the entire lifecycle of oncology treatment development.

Inflammation is a primary pathogenic process in a wide range of diseases, including rheumatoid arthritis, cardiovascular disease, oncology and neuropsychiatric disorders.

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

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