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The AI model that is changing clinical trial design

Drug Target Review

Clinical trials are expensive, slow and often limited by outdated design constraints. These digital twins are created for each trial participant using their baseline data – regardless of whether they are assigned to the placebo or treatment arm – and simulate how that individual would have responded under control conditions.

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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

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The Ultimate Guide to CRF Annotation in Clinical Trials

Quanticate

Clinical trials rely on comprehensive data collection to prove the investigational drug/device’s efficacy and safety, the Case Report Form (CRF), a structured document designed to record all trial-related data for each participant makes this possible.

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Transparency Requirements and the Requirement for Document Redaction

thought leadership

In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the integrity of the research process. The EU Clinical Trial Regulation (CTR) (No.

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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. Documentation/medical writing : Regional regulatory agencies (such as the U.S. The biotech industry is a dynamic sector, rapidly evolving and poised for continued growth.

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2025: Perspectives and Predictions From Advarra Thought Leaders

Advarra

AI can also automate labor-intensive tasks, such as extracting key information from protocol documents to populate downstream systems. For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed.

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Enhancing Clinical Trials: The Power of Contact Center Services

PPD

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.