Search

Reading Time: 3 minutesAt least one protocol amendment occurs in over half of all clinical trials according to Tufts Center for the Study of Drug Development (Tufts CSDD) research.1 Those amendments can disrupt sites and study teams, creating obstacles to efficiency. For example, sites may need to re-consent a patient if a change impacts how treatment will be delivered […]

Article

Reading Time: 5 minutesFrom small rare disease studies to large vaccine trials with tens of thousands of patients, clinical trial complexity has increased both in size and scope. But not all electronic data capture (EDC) systems can scale to accommodate the changing demands of today’s clinical trials. When clinical trial sponsors hit the limit of their EDC system’s […]

Article

Reading Time: 3 minutesOn May 20, Medidata proudly joins the global research community in celebrating Clinical Trials Day, an annual recognition of the clinical research professionals and participants who make life-changing medical progress possible. This date commemorates the first documented comparative clinical trial conducted by James Lind in 1747, who sought to find a cure for scurvy among […]

Article

Reading Time: 4 minutesMedidata is more than just Rave, as many already know. The clinical operations solutions are cutting edge and we are always looking for innovative ways to approach the processes and technology, especially within our clinical trial budgeting and site payments solutions. Our recent research showed that an inaccurate initial budget received by the site is […]

Article

Reading Time: 3 minutes3DExperience Lab The 3DExperience Lab is Dassault Systèmes ́ accelerator program for startups and aims to facilitate and nurture disruptive product innovation across the following themes: City, Life, and Lifestyle. The program lets companies access the 3DExperience platform, technical skills, and mentoring, as well as support during industrialization, product launch and support to increase international presence. […]

Article

Reading Time: 5 minutes Medidata’s first webinar series for 2022 was designed to bring together industry leaders to discuss the trends and insights in modernizing clinical data management. We would like to thank all attendees that participated in the first webinar of the series and featured Nicole Pollard (Managing, Principal Engagement Consultant, Medidata) and Katrina Rice (Chief Delivery Officer, […]

Article

Reading Time: 4 minutesAs in the words of Maverick and Goose in the movie Top Gun, “I feel the need...the need for speed,” it is critical that serious adverse events (SAEs) in clinical trials are logged, reported, and acted upon quickly. The trial sponsor is accountable for reporting SAEs to the regulatory authorities. The relevant authority is typically […]

Article

Reading Time: 4 minutes Technology continues to become an essential component of all aspects of healthcare. With this comes unique challenges, especially in the area of clinical trials and the use of electronic data capture (EDC). Innovative approaches are necessary to keep up with the expanding data capture and management landscape of the clinical trial process. At every juncture […]

Article

Reading Time: 4 minutesThe healthcare IT industry has advocated for interoperability within and across healthcare systems for nearly 20 years. While increased adoption of Health Level Seven (HL7) Fast Healthcare Interoperability Resource (FHIR) has helped the industry get closer to its goal, full interoperability remains a work in progress. Interoperability across clinical research faces similar challenges. In an […]

Article

Reading Time: 6 minutesHigh-quality clinical data analyzed promptly is essential for bringing lifesaving drugs to market faster. Several steps in the clinical trial workflow must be orchestrated seamlessly as per the study protocol and regulatory requirements. Any data recorded during the study must be collated into a database where it can be analyzed. All database entries must be […]

Article

Reading Time: 2 minutes Chimeric antigen receptor (CAR) T-cell therapy is an incredibly promising novel immunotherapy for several hematological cancers, especially for patients that have exhausted other treatment options. CAR T works by altering a patient’s own blood to produce artificial, genetically engineered T cell receptors that recognize and eliminate cancerous cells in the body.1 The most common form […]

Article

Reading Time: 3 minutesInnovation in life sciences is faster than ever before. This new age of clinical trial advancements means that both sponsors and technology vendors must evolve to meet the demands of this new paradigm. Sponsors need a proven digital strategy to successfully leverage novel technology within clinical trials. Medidata defines four key pillars for sponsors to become […]

Article