A Step-by-Step Guide to eConsent ICF (Informed Consent Form)

Introduction In the realm of clinical trials and research studies, a contemporary method known as electronic consent, or eConsent, has emerged to revolutionize the way informed consent is obtained from participants. Steering away from the conventional paper-based approach, eConsent leverages digital platforms or software to present participants with essential information and enable them to provide […]

RWE in Market Access & Health Economics: 3 Key Applications & 3 Key Benefits 

Real-world evidence (RWE) holds immense significance as a tool for comprehending treatment effectiveness within real-world settings. Notably, RWE offers invaluable insights into the cost-effectiveness of treatments and plays a crucial role in informing decisions pertaining to market access. In this article, we will explore three key applications and three key benefits of RWE in the […]

The Benefits of Real-World Evidence (RWE) for Pharmaceutical Companies

In the realm of healthcare, real-world evidence (RWE) serves as a cornerstone in guiding critical healthcare decisions and assessing the safety and efficacy of treatments. Drawing from various sources, such as patient medical records, claims data, and observational studies, RWE offers invaluable insights into the real-life outcomes of healthcare interventions. By leveraging this wealth of […]

Unleashing Potential for Digital Endpoints: How They Can Revolutionize Clinical Research

Digital endpoints have the potential to revolutionize clinical trials by providing real-time data collection, enhancing patient engagement, improving efficiency, and reducing costs. These new forms of data points are assessed using data captured by a sensor, typically outside of a clinic during daily living activities. The sensor can be worn like a pedometer in a […]

Unlocking the Key Insights: A 4-Part Framework to Characterize Real-World Data (RWD) for Regulatory Compliance

According to Acorn AI, one of the industry’s leading platforms supporting clinical trials, in 2020, approximately 75% of new drug applications (NDA) and Biologic License Applications already incorporate real-world data. Since then, there has been a notable increase in the utilization of RWD. However, like with any pioneering advancement, there exists challenges between the potential […]

The Importance of Quality Assurance and Control in Clinical Research

Clinical research stands at the forefront of medical advancements and the evolution of effective therapies and treatments. To establish unwavering trust in the results, studies must be conducted with uncompromising attention to detail. In this context, quality assurance and control emerge as indispensable pillars, safeguarding the delivery of the highest quality and most reliable outcomes. […]

Clinical Trials in Oncology: Where We Are Now and Where We’re Going

Cancer is a complex disease that affects millions of people around the world. In recent years, we have seen remarkable progress in both our knowledge of cancer’s biological mechanisms and the discovery of effective new treatments, with clinical trials remaining essential to advancing cancer research and getting new treatments to patients. Today’s clinical trials in […]

Is Your EDC System Future-Proof?

Technology has become increasingly integral to every facet of healthcare. This evolution, however, presents its own set of difficulties, particularly in the context of clinical trials involving electronic data capture (EDC). To keep up with the evolving landscape of clinical trial data capture and management, novel approaches are required. Both the sponsors and the CROs […]

The Significance of Randomization and Trial Supply Management in Clinical Trials

During the pandemic, sophisticated solutions were developed to manage the rapidity with which clinical trials began, the efficiency with which trials were conducted, and the speed with which patients received their medication. This new standard of high-speed, high-quality research has forced biopharmaceutical companies all over the world to follow suit and seek clinical trial solutions […]

The Significance of EMRs in Clinical Research

Clinical research is entering a new era where electronic medical records (EMRs) play an increasingly significant and novel supporting role. Today, better systems and new research infrastructure facilitate the use of EMRs for clinical research and trials. EMRs are convenient alternatives to traditional paper-based medical records, offering clinical researchers and physicians instantaneous access to well-organized […]