Centralized Monitoring – Enhancing Efficiency In Clinical Trial Management

Developing cost effective new drugs and therapies is a major challenge for life science industry. Drug development involves a number of phases among which the clinical trial phase is the most complex one. It needs planning, execution and monitoring of clinical trials to obtain reliable study data for regulatory submissions. However, in the clinical trial management, one of the major costs owes to the clinical monitoring. Studies have revealed that conducting frequent monitoring visits to investigational sites and 100% source data verification (SDV)through traditional ways don’t always lead to high data quality. This calls for a smarter and better approach for more efficient study data monitoring. A number of monitoring approaches have evolved these days but the centralized monitoring has been proved to be the most effective approach for improving patient safety and data quality in a cost effective manner. Many regulatory bodies, including FDA, encourage the use of centralized monitoring.

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Tips to Avoid Common HIPAA Violations

HIPAA breaches could cost your organization thousands of dollars, in addition to damaging your reputation and relationship with your patients. Penalties for not complying with HIPAA rules are divided into two categories: Reasonable Cause and Willful Neglect. Fine for a HIPAA breach owing to reasonable cause ranges between $100 and $50,000 per incident and doesn’t include any jail time. However, in case of willful neglect, the fine ranges from$10,000 to $50,000 for each incident and could also lead to criminal charges. Even a small HIPAA violation on the part of a single employee could jeopardize the reputation of the entire organization. Continue reading “Tips to Avoid Common HIPAA Violations”

Rules And Regulations Surrounding HIPAA Data Breach

With the implementation of new technologies, adoption of electronic health record technology and association with health information exchanges, more healthcare organizations are exposing themselves to HIPAA data breaches and other online threats. In this scenario Protected Health Information (PHI), in addition to being available to the concerned people, is also becoming more and more accessible to hackers and unauthorized third parties. This means covered entities and business associates need to stay updated about the advancing technologies to maintain PHI security. Understanding the basics and underlying reasons for HIPAA data breach is the first step in creating comprehensive data security plans which the healthcare organizations can apply to their daily operations.  Continue reading “Rules And Regulations Surrounding HIPAA Data Breach”

Double Up Your Learning Benefits With HRCI And SHRM Approved Webinars

A Continuing Education Credit (CEC) or Continuing Education Unit (CEU) refers to a measure used in continuing education programs for helping professionals maintain their license in the profession. Continuing education is mandatory in several fields and is described as participation in different educational programs and activities. Continue reading “Double Up Your Learning Benefits With HRCI And SHRM Approved Webinars”

How Medical Education is Shifting the Focus to Choosing Wisely?

Just like ‘too little care’, ‘too much care’ could also be detrimental to patients. Over the past few decades, the testing and treatment options in the medical arena have increased manifold. The patients are being subjected to over-testing and over-treatment which is leading to consequences like unnecessary surgeries, physical sufferings, painful side effects and financial losses that impacts the household budgets severely. Continue reading “How Medical Education is Shifting the Focus to Choosing Wisely?”

MACRA and MIPS: New Regulations in Medical Practices

The healthcare sector is evolving at a great pace and new regulations keep making their way into it, along with new related acronyms. Two recent acronyms that have emerged in healthcare are MACRA and MIPS. These have become a prominent addition to the medical practices and to follow them properly it’s important that you understand the regulations well. Lately there has been significant changes regarding how the medicare pays for physician services. MACRA and MIPS have a significant impact on many health plans. Continue reading “MACRA and MIPS: New Regulations in Medical Practices”

Digitalization of Clinical Trials – The Benefits

Clinical trials in the development of any new medicine are time-consuming as well as costly. Over the years, the pharmaceutical industry has been trying all means and ways to reduce cycle times and costs in clinical trials through clinical trial process redesign, Business Process Outsourcing (BPO) and risk-based monitoring. However, nothing worked wonders in having a transformation on the overall clinical trial process. Continue reading “Digitalization of Clinical Trials – The Benefits”

Why Mobile Learning?

A recent research by Pew Research Center showed that nearly 72% adults in the United States own a Smartphone. Mobile device is an innovation that has drastically transformed the way info is obtained and used. Mobile phones have become such an important necessity that everyone wishes to own at least one. As a result, e-learning industries are taking huge advantage of this.
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