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?
On June 26, 2024, the FDA issued new draft guidance describing the format and content, medical products, clinical studies, timing, and process for submitting diversity action plans. Likewise, the criteria and process by which the FDA will evaluate sponsors’ requests for exemption from this requirement. This guidance is a response to the FDORA Act… Continue reading 2024 FDA Draft Guidance on Diversity Action Plans: Enhancing Inclusion in Clinical Studies
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
Clinical trial participation is the core of future medical advances. But for sites, recruiting patients in clinical trials and conducting them on the journey is usually a challenging task, driving to nearly 80% of trials failing to meet on-time enrollment (1). In a digital era, technology is at the service of improved trial participation and… Continue reading Six Benefits of Automating the Recruiting Flow in Clinical Trials
From the ideation of the scientific question, sponsors can consider integrating ePRO tools in protocol designs. Decentralized and hybrid clinical trials can widen the data points and make the most of each trial. Here we share five steps to introduce an ePRO into a protocol: Define the objectives an ePRO tool can address: Identify the… Continue reading How to include an ePRO in your protocol design
Table of Contents In a world where it seems everyone is talking about artificial intelligence, and its numerous benefits, we cannot ignore the fact that artificial intelligence is transforming industries and sectors all over the world and one of them is the pharmaceutical area. Essentially, AI is a robust tool helping to overcome large problems… Continue reading How Artificial Intelligence is Transforming Clinical Trials: The Case of AstraZeneca
Table of Contents What is eConsent and How Does it Improve Clinical Trials? We all recognize the vital role informed consent plays in clinical trials. These trials operate under a complex set of regulations governing how consent is obtained. It is estimated that eConsent implementation in clinical trials reduce the time spent on consent-related tasks… Continue reading eConsent Software for Optimal Clinical Trials
Table of Contents This blog provides the immense potential of CRISPR, a revolutionary genome editing tool that is revolutionizing the field of DNA editing. What is CRISPR? CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a gene-editing technology that allows scientists to modify DNA sequences with high precision and efficiency. It is based on a… Continue reading CRISPR: The Promise of Gene Editing in Clinical Trials
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