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… Continue reading 7 Principles for Good Clinical Practices in Clinical Trials
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… Continue reading Efficiency in Clinical Trials: Excel vs CTMS?
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… Continue reading Electronic Medical Records 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… Continue reading Patient Recruitment in Clinical Trials
Table of Contents When developing new vaccines, patient safety is paramount. Phase I vaccine trials determine safety and efficacy before public release. Data collection is crucial for evaluating the vaccine’s performance. Electronic Patient Reported Outcomes (ePRO) are valuable tools in ensuring patient safety during Phase I vaccine trials. This article explores the importance of… Continue reading Phase I Vaccine Trials & ePRO: Ensuring Patient Safety
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.… Continue reading The Power of Data in Clinical Trial Execution Decision Making
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… Continue reading Why implement electronic source documents (eSource) in clinical research centers?
Cancer is a leading cause of death in Latin America, with the region experiencing an alarming rise in cases. It is projected that by 2040, 9 out of 10 of the most populous nations in Latin America will see an increase of at least 64% in the number of people diagnosed with cancer annually. This… Continue reading Cancer Research in Latin America
New medical treatments haven’t reached everyone equally. Why? A lack of diversity in clinical trials. African Americans make up 13% of the US population but only 5% of clinical trial participants. Similarly, Hispanics are vastly underrepresented, comprising 15% of the population but just 1% of trial participants. (1) This disparity has real-world consequences. Treatments… Continue reading Why Diversity in Clinical Trials Matters
Artificial intelligence (AI) and machine learning (ML) herald a new era of regulatory operations in clinical trials. These advanced technologies are revolutionizing how companies manage regulatory data, predict outcomes, and ensure compliance, ultimately leading to greater efficiency and accuracy. From the IQVIA article published on its website on June 10, 2024, we would like… Continue reading 4 Key Benefits of AI & Machine Learning in Clinical Trials
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