Regulatory Compliance in Clinical Trials: A Complete Guide
Table of Contents Introduction Regulatory compliance in clinical trials is a cornerstone for ensuring participant safety, data quality, and scientific validity. For many organizations, achieving compliance is a significant challenge that demands advanced technological tools. For PROBEBÉ, implementing Trial360 transformed their regulatory management process, enhancing efficiency and adherence to international regulations. See how they […]
Clinical Research Center Challenges: How an ERP CRM Solution like Trial 360 Based on Odoo Solves Them
Table of Contents In clinical research, centers face numerous challenges in managing processes, data, and regulations. An ERP-CRM solution like Trial 360, based on the robust Odoo platform, provides essential tools to address these issues and improve operational efficiency, traceability, and regulatory compliance. Main Challenges and Solutions with Trial 360 Disorganized Clinical Trial Management Pain: […]
Why Trial360 is better than paper?
Table of Contents Are you tired of using tons of paper to manage your clinical trials? You’re not alone. Clinical trials are complex, and paper-based systems can make them even more chaotic. Traditional paper-based methods for managing clinical trials are often slow, error-prone, and difficult to scale. Many research centers, especially in Latin […]
What is a CTMS? The Clinical Trial Management Key
Table of Contents Effective clinical trial management is critical to success in drug development. A clinical trial management system (CTMS) is an essential tool that enables sponsors and clinical research organizations (CROs) to facilitate their trial processes. A CTMS centralizes and automates many trial management functions, from planning to study closure. CTMSs help teams improve […]
7 Principles for Good Clinical Practices in Clinical Trials
Table of Contents Adherence to Good Clinical Practices (GCPs) is mandatory in clinical trials. These rigorous standards ensure safety, ethics, and reliability in medical research. However, GCP compliance can be challenging, especially given the increasing regulatory scrutiny and the sheer volume of data generated in modern trials. Fortunately, digital solutions offer a powerful toolkit to […]
Efficiency in Clinical Trials: Excel vs CTMS?
Table of Contents Utilizing CTMS can cut operational costs by about 25%, making clinical trials more cost-effective. This significant reduction in expenses allows research centers to allocate resources more efficiently, ultimately accelerating the development of new treatments. The Limitations of Excel-Based Clinical Trial Management Excel has long been a popular tool for managing clinical trial […]
Electronic Medical Records in Clinical Trials
Table of Contents For many research centers or networks, traditional methods such as paper documentation and non-integrated systems have become major bottlenecks, slowing down processes and compromising data accuracy. The Instituto de Investigations Clinicas Mar del Plata in Argentina faced similar challenges but transformed its operations by implementing an electronic source document and a […]
Patient Recruitment in Clinical Trials
Table of Contents Why are patient recruitment and retention important for clinical trials? A clinical study’s purpose is to answer a research question. To do so, researchers must recruit appropriate participants and retain as many as possible for the period specified in the protocol. If recruitment or retention is insufficient, a study may not […]
The Power of Data in Clinical Trial Execution Decision Making
Table of Contents Despite its critical nature, decision-making in research centers often relies on traditional methods, leading to inefficiencies and errors. This blog discusses how real-time, data-driven decision-making is transforming the clinical research landscape. It highlights the crucial role of dashboards in optimizing operational efficiency, improving patient outcomes, and streamlining the clinical trial execution process. […]
Why implement electronic source documents (eSource) in clinical research centers?
Table of Contents Since 2010, regulatory bodies globally have expressed interest or provided written guidance on their expectations regarding the electronic source document (eSource). What is an electronic source document? eSource refers to using electronic systems and devices to capture, collect, and store data during clinical trials. This includes direct data entry by patients, healthcare […]
