Tag: clinical trials

Impact Assessment for Protocol Deviations: Building a Risk-Based Framework

Posted on By digi

Impact Assessment for Protocol Deviations: Building a Risk-Based Framework Impact Assessment for Protocol Deviations: Building a Risk-Based Framework Protocol deviations are a significant concern in clinical trials, affecting data integrity, regulatory compliance, and overall study outcomes. This article serves as a step-by-step tutorial on conducting impact assessments for protocol deviations, emphasizing a risk-based framework that…

Read More “Impact Assessment for Protocol Deviations: Building a Risk-Based Framework” »

Impact Assessment & Risk Categorization

How to Categorize Deviations by Subject Safety, Data Integrity and Regulatory Impact

Posted on By digi

How to Categorize Deviations by Subject Safety, Data Integrity and Regulatory Impact How to Categorize Deviations by Subject Safety, Data Integrity and Regulatory Impact In the intricate world of clinical trials, deviations from the protocol can significantly impact the study’s integrity, participant safety, and regulatory compliance. This tutorial provides a structured and detailed approach for…

Read More “How to Categorize Deviations by Subject Safety, Data Integrity and Regulatory Impact” »

Impact Assessment & Risk Categorization

Plain-Language Summaries & Layperson Results: Compliance Strategy for US, EU and UK Clinical Programs

Posted on By digi

Plain-Language Summaries & Layperson Results: Compliance Strategy for US, EU and UK Clinical Programs Clinical trials are a critical component in the development of new therapies, particularly in complex therapeutic areas such as oncology. As clinical research continues to evolve, regulations surrounding clinical trial transparency have become increasingly stringent. This article provides a comprehensive, step-by-step…

Read More “Plain-Language Summaries & Layperson Results: Compliance Strategy for US, EU and UK Clinical Programs” »

Plain-Language Summaries & Layperson Results

How to Design Plain-Language Summaries & Layperson Results That Meets FDA, EMA and MHRA Expectations

Posted on By digi

How to Design Plain-Language Summaries & Layperson Results That Meets FDA, EMA and MHRA Expectations How to Design Plain-Language Summaries & Layperson Results That Meets FDA, EMA and MHRA Expectations In the complex landscape of clinical trials, the importance of clear and accessible communication cannot be overstated. Regulatory authorities such as the FDA, EMA, and…

Read More “How to Design Plain-Language Summaries & Layperson Results That Meets FDA, EMA and MHRA Expectations” »

Plain-Language Summaries & Layperson Results

Protocol Synopsis & Full Protocol: Inspection-Ready Standards for US, UK and EU Clinical Trials

Posted on By digi

Protocol Synopsis & Full Protocol: Inspection-Ready Standards for US, UK and EU Clinical Trials Introduction to Clinical Trials Protocols Clinical trials are foundational to the advancement of medical knowledge and therapeutics. Standardized protocols are essential to ensure both the integrity of the research and compliance with regulatory requirements. The protocol serves as a blueprint for…

Read More “Protocol Synopsis & Full Protocol: Inspection-Ready Standards for US, UK and EU Clinical Trials” »

Protocol Synopsis & Full Protocol

Case Studies: Streamlined Deviation Workflows That Shortened Study Close-Out

Posted on By digi

Case Studies: Streamlined Deviation Workflows That Shortened Study Close-Out Clinical trials are critical to advancing medical knowledge, particularly in the realm of treating diseases such as non-small cell lung cancer (NSCLC). However, the complexity of clinical research often leads to protocol deviations, which can result in costly delays during study close-out. This article will provide…

Read More “Case Studies: Streamlined Deviation Workflows That Shortened Study Close-Out” »

Documentation & Reporting Workflows

Future-Proofing Deviation Reporting for DCT and App-Based Data Capture

Posted on By digi

Future-Proofing Deviation Reporting for DCT and App-Based Data Capture Future-Proofing Deviation Reporting for DCT and App-Based Data Capture As the clinical trial landscape evolves with the integration of digital technologies, ensuring compliance in deviation reporting becomes critical. This article serves as a step-by-step guide for clinical operations, regulatory affairs, and medical affairs professionals on how…

Read More “Future-Proofing Deviation Reporting for DCT and App-Based Data Capture” »

Documentation & Reporting Workflows

Using Results Posting & Timelines to Support Publications, HTA and Market Access

Posted on By digi

Using Results Posting & Timelines to Support Publications, HTA and Market Access In the current regulatory environment, the requirements surrounding clinical trial transparency and disclosure are paramount. This detailed tutorial serves as a comprehensive guide for clinical operations, regulatory affairs, and medical affairs professionals engaged in clinical trials, particularly focusing on the posting of results,…

Read More “Using Results Posting & Timelines to Support Publications, HTA and Market Access” »

Results Posting & Timelines

Future Trends: AI, Real-World Data and Evolving Rules for Results Posting & Timelines

Posted on By digi

Future Trends: AI, Real-World Data and Evolving Rules for Results Posting & Timelines Future Trends: AI, Real-World Data and Evolving Rules for Results Posting & Timelines The evolution of clinical trials has been significantly influenced by advancements in artificial intelligence (AI), the integration of real-world data (RWD), and the regulatory landscape governing results posting. The…

Read More “Future Trends: AI, Real-World Data and Evolving Rules for Results Posting & Timelines” »

Results Posting & Timelines

Future-Proofing Investigator’s Brochure (IB) Authoring & Updates for Digital Tools, AI and Real-World Data

Posted on By digi

Future-Proofing Investigator’s Brochure (IB) Authoring & Updates for Digital Tools, AI and Real-World Data Future-Proofing Investigator’s Brochure (IB) Authoring & Updates for Digital Tools, AI and Real-World Data The execution of clinical trials has evolved dramatically due to technological advances, including digital tools and artificial intelligence (AI). This shift necessitates a thorough understanding of the…

Read More “Future-Proofing Investigator’s Brochure (IB) Authoring & Updates for Digital Tools, AI and Real-World Data” »

Investigator’s Brochure (IB) Authoring & Updates