Accelerate Digital Transformation
Bringing a new drug to the market is an expensive venture and can take up to 10 to 15 years from discovery to launch. Clinical trial costs are increasing and so is the complexity of managing it. According to the Tufts CSDD March 2019 Report, Sponsors are spending more on CROs for developing new medicines Read more about 8 Key Challenges to Clinical Trial Budgeting[…]
The modern jargon “patient centricity” and “patient engagement” has been revolving a lot around the industry. Patient centricity refers to the design, development, and conduct of clinical trials, keeping in mind the needs of the patient. Patient engagement refers to the patient’s activity and retained participation in clinical trials. There is a huge difference between Read more about Making Clinical Trials Patient Centric – Essential Best Practices[…]
The violations of regulatory compliance may lead to the issue of FDA Warning Letters. Over the recent years, most of these warning letters are due to non-compliance or negligence in the audit trail documentation practices. Most frequent reasons to Issue FDA warning letters Document control best practices to help companies avoid FDA warning letters 1. Establish Document Control Read more about 5 Ways to Avoid FDA Warning Letters through Automated CTMS Solution[…]
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[…]
Virtual trials are otherwise called Siteless trials done partly or on the whole virtually. The mobile device or wearable sensors such as a phone, watch, or even glasses can be used to collect the medical data in the clinical research study. Patients are treated via Telemedicine and Medical devices. Healthcare providers can evaluate, diagnose and Read more about Virtual Trials – Benefits and Challenges[…]
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[…]