Author: digi

Training Investigators for Virtual Interactions in Decentralized Clinical Trials

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Training Investigators for Virtual Interactions in Decentralized Clinical Trials How to Train Clinical Trial Investigators for Virtual Interactions in DCTs As decentralized clinical trials (DCTs) reshape modern clinical research, virtual interactions between investigators and patients are now integral. Whether it’s conducting remote informed consent or following up on adverse events, investigators must be fully equipped…

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Decentralized Clinical Trials (DCTs), Telemedicine in Trials

What Happens Between Phase 3 Completion and NDA/BLA Filing: Post-Trial Activities Explained

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What Happens Between Phase 3 Completion and NDA/BLA Filing: Post-Trial Activities Explained Understanding the Process Between End of Phase 3 and Filing of NDA/BLA Why the Post-Phase 3 Period Is Crucial Completing a Phase 3 trial marks a major milestone in the drug development journey—but it’s not the finish line. The period between Phase 3…

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Phase 3 (Confirmation and Monitoring)

SIV Delays in Clinical Trials: Common Causes and Effective Solutions

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Managing SIV Delays: Causes and Solutions for Timely Site Initiation Delays in Site Initiation Visits (SIVs) are among the top reasons for postponed study start dates in clinical trials. SIVs are the final pre-activation step where the sponsor or CRO ensures that the investigative site is fully trained and compliant before enrolling the first subject….

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Site Initiation Visits, Site Management and Monitoring

Examples of Niche CROs Focused on Rare Diseases

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Examples of Niche CROs Focused on Rare Diseases Specialty CROs Supporting Rare Disease Clinical Trials: Top Examples Rare diseases—often defined as conditions affecting fewer than 200,000 people in the US—present unique challenges for clinical trials. These include small patient populations, geographic dispersion, lack of historical data, and complex regulatory pathways. To address these hurdles, many…

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Contract Research Organizations (CROs), Niche/Specialty CROs

Adherence and Compliance Studies in Phase 4 Clinical Trials

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Adherence and Compliance Studies in Phase 4 Clinical Trials Evaluating Medication Adherence and Patient Compliance in Phase 4 Clinical Trials Introduction Even the most effective drug cannot yield results if patients do not take it as prescribed. Medication adherence and patient compliance are vital metrics that significantly influence clinical outcomes, healthcare costs, and real-world effectiveness….

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Phase 4 (Post-Marketing Surveillance)

How to Handle Conditional Ethics Approvals in Clinical Trials

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How to Handle Conditional Ethics Approvals in Clinical Trials Managing Conditional Ethics Approvals in Clinical Trials: A Step-by-Step Guide Receiving a conditional approval from an Ethics Committee (EC) or Institutional Review Board (IRB) is a common scenario in clinical research. It means the study is ethically approvable pending specific clarifications or modifications. Handling conditional approvals…

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Ethics Committee Submissions, Informed Consent and Ethics Committees

Ethical and Regulatory Review of Cluster Trials – Clinical Trial Design and Protocol Development

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Ethical and Regulatory Review of Cluster Trials – Clinical Trial Design and Protocol Development “Review of Ethical and Regulatory Aspects in Cluster Trials” Introduction Cluster randomized trials (CRTs) offer a unique approach to clinical research, but they also present a distinct set of ethical and regulatory challenges. In CRTs, groups or clusters of individuals, rather…

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Clinical Trial Design and Protocol Development, Cluster Randomized Trials

Site Selection Challenges in Emerging Markets for Clinical Trials

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Navigating Site Selection Challenges in Emerging Markets for Clinical Trials Emerging markets—such as parts of Asia, Africa, Latin America, and Eastern Europe—are becoming increasingly attractive for clinical trial conduct. These regions offer large treatment-naïve populations, reduced costs, and diverse disease prevalence. However, site selection in emerging markets comes with its own set of logistical, regulatory,…

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Clinical Research Operations, Site Selection and Initiation

Using Remote Monitoring to Enhance Trial Continuity and Retention

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Using Remote Monitoring to Enhance Trial Continuity and Retention How Remote Monitoring Improves Trial Continuity and Patient Retention The clinical trial landscape is rapidly evolving, and remote monitoring is at the center of this transformation. As trials expand geographically and adapt to decentralized models, retaining participants and ensuring uninterrupted data collection has become increasingly complex….

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Patient Recruitment and Retention, Retention Strategies

Controlled Human Infection Models (CHIM) in Early Vaccine Studies

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Controlled Human Infection Models (CHIM) in Early Vaccine Studies Applying CHIM Studies in Early-Phase Vaccine Development Introduction Controlled Human Infection Models (CHIM), also known as human challenge studies, are a powerful and controversial tool in early vaccine development. In CHIM studies, healthy volunteers are deliberately exposed to a pathogen under tightly controlled conditions to assess…

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Phase 1 (Safety and Dosage)