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 management 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.
HIPAA violations 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”
For being a successful manager, you must understand and master the strategies for keeping the employees motivated to perform at high level. Employee motivation is an important factor that leads to higher productivity and business growth.
Managers use different techniques to assess the personality and behavior of different employees motivated and to determine what motivates them. For this, it’s important to know them and understand their goals and aspirations to implement strategies that work best in keeping them motivated. However, there is no one-size-fits-all approach for employee motivation because all the employees are quite different from each other and different factors impact their motivation. Thus, a manager needs to employ different strategies to keep up the motivation and productivity of employees.
Here are 10 strategies that you can employ to keep up the motivation of your employees:
GRC Implementation is the acronym for Governance, Risk Management and Compliance. It refers to the integrated collection of capabilities that help an organization in achieving objectives, addressing uncertainty and acting with integrity. GRC as a business practice aims at creating a synchronized approach toward three areas – governance, risk management and compliance. To make a business successful, it’s important to have an effective GRC platform. And, owing to the changing regulatory landscape, it’s becoming more and more important to have a heightened level of awareness about GRC for the improvement of business longevity and corporate culture. Talking about having a GRC platform, many organizations find it challenging to decide what type of platform would be suitable for them and how the suitable framework can be implemented successfully in the business. Continue reading “Key Steps for a Successful GRC Implementation”
Research reveals that a typical company loses a significant amount of its revenue to fraud every year. Alarming it is but the majority of the organizations still deny that they might be vulnerable to effective internal controls for fraud prevention. Association of Certified Fraud Examiners (ACFE) suggests that many of the fraud cases are never detected because fraud inherently involves efforts of concealment. This calls for the implementation of strong anti-fraud controls to reduce the opportunities for committing fraud. Also, the attitude of the company towards internal controls, fraud, and ethical culture is an important requisite for fraud prevention. Continue reading “Effective Internal Controls for Fraud Prevention”
Recruiting the right job candidate is becoming a tough job day by day and if you are not using innovative strategies, you would be wasting a lot of your time and money in the process. There has been a lot of advancement in the HR technologies for the improvement of Fasten the Hiring Process.
Finding the right candidate requires a well-planned strategy. And, to understand the significance of such a strategy, it’s also important to note that the process of talent acquisition never really stops. Previously, recruitment process mainly involved posting a job on job boards and waiting for applications, which was actually enough. However, now the time has changed and there is a dire need of a strong employer branding strategy for attracting the brilliant minds to fill the hard-to-fill positions, Here are some strategies that you must keep in mind to find the best candidate for your organization.
Sexual harassment is an umbrella term encompassing a number of unwanted behaviors that include physical as well as non-physical harassment. Sexual harassment in your workplace is a serious issue and, no matter how large or small the incidents are and who is involved, managers or employers must take quick and appropriate actions. Sexual harassment can be perpetrated by anyone in the workplace like a co-worker, manager or a client. The perpetrator and the recipient could be anyone, irrespective of the gender. Physical harassment includes touches, hugs and coerced sex acts whereas non-physical harassment includes suggestive gestures and remarks, and requests for sexual fervors. In fact any conduct of sexual nature that makes an employee uncomfortable can be termed as sexual harassment. Continue reading “Strategies To Prevent Sexual Harassment In Your Workplace”
Exporters are increasingly feeling the pressure to conform to international compliance standards if they are to enter successfully developed country markets. Food safety regulations and quality have become increasingly important globally in recent years, not only in terms of protecting the health of the consumer and ensuring food safety, but also to meet requirements for international trade. To facilitate such trade, it is necessary to implement international standards, guidelines, and recommendations for the production of safe and quality-assured foods.
In the food sector, periodic outbreaks of food-borne illnesses have led to stricter regulation, making suppliers of branded produce liable for the safety of their products unless they can show due diligence. The first thing needed by enterprises considering exporting their products is up-to-date information about the applicable technical requirements, both voluntary and mandatory, in the target markets. After obtaining the right information, enterprises have to adapt their products to export market requirements. This may require expensive investment to purchase equipment and upgrade infrastructure.
In the recent years, virtual currencies have gained a lot of prominence in the real world. Different types of virtual currency have evolved, which have also resulted in the increased risks in the areas of information technology, compliance, and financial crime. Virtual currencies are available in the digital form and do not follow the same regulations as the e-money (traditional currency exchanged electronically). However, with the growing popularity of virtual currencies, regulatory expectations and guidance on their risk management are also emerging at a fast pace. Failure to meet the regulations may lead to severe consequences like criminal or civil penalties, in case the money is laundered through the virtual currencies system. Continue reading “Virtual Currency – Maintaining Compliance with Regulations”
Anti Money laundering continues to be a major issue in the financial ecosystem but the methods are changing drastically in this technology-driven era. The Bank Secrecy Act (BSA) was introduced long back, mandating the reporting of suspected fraud or laundering. However, now the Financial Crimes Enforcement Network (FinCEN) has modified and expanded the anti-money laundering (AML) requirements. Financial organizations now have rules, outlined by the Department of the Treasury agency, to include reporting cyber-enabled crime and cyber-events through Suspicious Activity Reports (SARs). Apart from including the questionable activity by customers, the updated rules also include suspicious activity on the bank level. Continue reading “Anti Money Laundering in the Digital Era”