Clinical trials are meant to determine whether devices, medications, or other developments in the medical field are safe for public use. These developments are at the cutting edge of the field, yet frequently, the trials to test their safety don’t incorporate the latest technologies (such as mobility).
There are reasons that companies have been leery of implementing mobile technologies in mobile trials: they’re concerned about regulatory issues, patient adherence, and cost. However, with the adoption of best practices, firms should no longer be concerned about using mobile technologies during regulatory trials.
The life sciences field has begun to embrace mobile technologies. Companies realize that it can make them more profitable and competitive. There are a number of ways in which mobile technologies can be implemented in this sector. This post will deal with how field service technicians in the life sciences field can become more efficient as a result of mobile technologies.
Successful life sciences businesses cannot rely on disparate, specialty software for very long. Without real-time, reliable data, companies simply can’t respond fast enough to deviations in plans or take advantage of new opportunities. A centralized, integrated business management solution will provide a single source of the truth, providing the data leaders need to make decisions that improve operations, boost productivity and profitability, and drive growth.
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When mobile devices first began to make their way into the enterprise, they represented uncharted territory for businesses. Many firms still grapple with how to manage, support, and secure these devices. Life sciences companies are no exception.
The enterprise has developed a few approaches to dealing with mobile technologies. One of them is corporate owned, personally enabled (COPE) devices. Read on to learn the benefits, risks and challenges, and best practices for the life sciences industry.
Bringing your own device (BYOD) to work has become commonplace in virtually every field and industry, and life sciences is no exception. For employees, BYOD is enormously freeing – they can use the devices they want when they want them. For IT departments and companies, BYOD can be a nightmare. There are significant security concerns and compliance issues to navigate regarding mobility. Read on to learn how life science firms can balance the benefits of BYOD with the risks and challenges through best practices.
Every developed country has a set of regulations governing Life Science companies that operate or market within its borders. The regulations mainly center on testing, certifications and approvals for products, but the sections most affected by ERP relate to electronic systems and signatures. Most country regulations are very similar to the U.S. Federal Register’s 21 CFR Part 11, although each country has slight variations in requirements or procedures. For example, APEC (Asia Pacific Economic Cooperation) has its LSIF (Life Science Innovation Forum) to help ensure supply chain integrity for health care products and medical devices. Health Canada (HC) regulates medical devices and health care products moving into or out of Canada, and Japan’s Ministry of Health, Labour and Welfare (MHLW) has JPAL for the same purpose.
In addition to unique industry requirements related to compliance, Life Sciences companies need ERP systems that are at least as functional and performant as companies in other industries do. Life Sciences companies should ensure that any ERP system they consider has the following characteristics – in addition to the industry specific needs they have in order to operate in a heavily regulated industry.