Vaccine development is a detailed process, broken into clearly defined phases. Each phase addresses specific questions about the safety, efficacy, and scalability of new vaccines, with the ultimate goal of protecting public health. Preclinical Vaccine Research Objectives: [...]

In clinical trials, efficient operations and detailed documentation drive success. A clinical trial management system (CTMS) and an electronic trial master file (eTMF) are two foundational elements, each with distinct purposes. CTMS focuses on operational oversight, while eTMF[...]

Interactive response technology (IRT) systems have changed the way clinical trials are managed. By automating key processes like patient randomization, drug supply management, and data collection, IRT streamlines operations and ensures precision. The integration of IRT systems[...]

Compliance in clinical trials is fundamental to protecting the rights of research participants, preserving data integrity, and advancing medical knowledge. To achieve this, trials must adhere to regulatory requirements as well as trial-specific protocols that outline precise[...]

*In clinical research, case report forms (CRFs) and electronic data capture (EDC) systems are often used interchangeably. In the context of this article, CRFs refer to the forms that collect the required clinical data for analysis—the actual data points. The EDC system is the[...]

Effective clinical trial project management supports smooth trial operations by coordinating regulatory compliance, data management, and stakeholder engagement. It's a matter of managing timelines, controlling budgets, and overseeing recruitment strategies to maintain trial[...]

Effectively managing clinical trial data is crucial for maintaining research integrity and compliance. Researchers typically use clinical trial management systems (CTMS) to orchestrate trial operations, and integrate with electronic data capture (EDC) for centralized data[...]

A clinical trial management system (CTMS) streamlines clinical trial operations from startup to closeout. It centralizes protocols, subjects, and financials, enhancing efficiency and oversight. Clinical research professionals gain improved visibility into trial progress and[...]