Clinical trials are research investigations in which people volunteer to evaluate medical, surgical, or behavioral intervention. The trial confirms a new treatment, less side effects and helps to make a better life for people with a chronic health problem. The U.S. Food and Drug Administration(FDA) typically requires Phase I, II, and III trials to determine Read more about Plan the Clinical Trial Design – The Cloudbyz Way[…]
The trial master file is a collection of all essential clinical documents that enable the conduct of the trial and quality of data produced which is to be stored, evaluated, and maintained. An electronic TMF is the digital repository of all documents, agreements, contracts that are maintained and archived after every trial closeout. The major Read more about Top 5 TMF, eTMF Challenges[…]
The arrival of game-changing technologies like mobile apps, social media, cloud computing has brought forth a new standard in the operational & decision-making process for many businesses. The CIO’s and IT Leaders role continues to undergo a transformation that is driving business leaders closer to customer demands and experiences. CIO challenges are complex and enormous. Read more about Top 4 challenges facing CIO’s and IT Leaders in 2019[…]
Pharmacovigilance is a continuous process of collection and analysis of data relating to the detection, assessment, understanding, and prevention of adverse events of medicines and medical devices. Pharmacovigilance is critical for the Healthcare industry for approval of new drugs and devices and to further promote their safe use post-approval. The Challenges to Pharmacovigilance were Read more about Cloudbyz – Safety Pharmacovigilance Solution[…]
Pharmacovigilance focuses on drug quality, medication errors and adverse drug reactions which impact the health care system by affecting a significant patient population. WHO defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem” Ultimately, pharmacovigilance is regarded as the constant Read more about Top 5 Challenges in Pharmacovigilance[…]
Clinical trials are essential for developing new treatments, to understand the efficiency and safety of the drugs to be used for treating Patients. People should be encouraged to participate in clinical trials as they are going to be a part of the innovation which in turn will help a huge population of suffering patients. Read more about Solutions to improve Patient Enrollment and Retention in Clinical Trials[…]
A successful clinical trial depends on effectively enrolling and retaining participants. As the study progresses from Phase 1 to Phase 3 the number of participants required increases. Research shows that 9 out of 10 trials would not meet enrollment goals in a stipulated time which results in delays in finding new and better medication. The Read more about Patient enrollment and retention challenges in Clinical trials[…]
Healthcare industry as a whole is now looking to better engage with patients using bots, where, the patients care aspect is being automated. The impersonal nature of the bots has a benefit in various situations, wherein a real doctor is not needed. In many cases, patients are more transparent to these chatbots than they Read more about How Chatbots can be employed in Clinical Trials?[…]
PRIORITIZATION IN THE CONTEXT OF PROJECT PORTFOLIO MANAGEMENT Portfolio management is about maximizing organizational value delivery through programs and projects. In order to maximize value delivery, the governance teams that approve work and prioritize projects need to share a common view of “value” in order to use a scoring model to select the most valuable Read more about A Guide to Building a Project Prioritization Scoring Model[…]
What is the difference between a work intake process and a Stage-Gate process? This is important to distinguish, especially for newer PMO’s that are setting up portfolio management processes. Work Intake The work in-take process refers to the steps of developing a project proposal and bringing it to the governance board (or PMO) for a Read more about Know The Difference Between Work Intake Versus Stage-Gate[…]