If meeting customer demands was not challenging enough, there are the additional needs for ensuring compliance with FDA 21 CFR Part 11 requirements, FSMA regulations, USDA and trade stipulations. Process manufacturers must have the ability to quickly track and trace materials and costs throughout the supply chain, both as a matter of best practice and to support regulatory compliance.
Your process is only as effective as the poorest performing equipment on the line. This constrains profitability, schedule compliance, uptime and safety.
CLINICAL TRANSPARENCY
Clinical trial sponsors are required by law to disclose information on their clinical trials in multiple places. These regulatory requirements continue to change as new mandated registries emerge and the scope of disclosure expands. This dynamic scenario creates a challenge for sponsors who must track and manage disclosure content that is being prepared for different registries, with different requirements.
Flexan/FMI uses medical grade silicone for implantable and disposable medical devices that require high performance and safety characteristics whenever in contact with a human body. With no side effects and the ability to be sterilized, this material meets or exceeds all USP Class VI test requirements. It will also retain its shape under pressure and temperature extremes.
Our team of Regulatory Affairs experts plays a pivotal role in your project from start to finish. In addition to compliance with applicable laws and guidelines, they scrutinize the appropriate licensing and legal compliance of pharmaceutical and medical products, thereby ensuring the quality, safety and efficacy of products.
The unfailing ability to complete enrollment on time, every time, has been the greatest yet most elusive need among clinical trial managers. While the value of the external patient is becoming more apparent, finding optimum solutions for integrating them into a study’s enrollment strategy is not so obvious. In their struggle to find answers, clinical trial managers experiment with, and try to piece together, services and offerings from a wide and disparate range of sources. The results are as varied as the choices. Now, a new approach to patient enrollment is emerging – one that could change the world of clinical trials.
Although many companies have internal project management teams, it is often most efficient to turn to outside resources to support large-scale solution deployments. Recently, United Rentals, Inc. did just that.
The Maverick Group’s excellent work has led to sustained expansion for two decades. And in recent years, that impressive growth curve began to turn even more sharply upward thanks to an ever-growing list of projects completed on-time and error-free. As company President Jose Rodriguez looked to the future, he began to question whether the company’s existing devices could keep up.
Changing and creating documentation involves many disciplines and long lead times. This case study explains how to improve Global Documentation Change Control Processes quickly and easily.
With a proliferation of cloud-based technologies already improving clinical trial performance, it is surprising that Excel spreadsheets are still a predominant force. Research dating back to the late 1990s and early 2000s documents that Excel was not designed to collect and analyze clinical trial data and it lacks project management capability, yet its extensive use persists.
Cell and gene therapies are currently produced in fixed facilities that require a significant upfront investment. Modular concepts offer an opportunity to shift from these large, fixed assets.
High-volume Kodak i5850 Scanners backed by Alaris service and support provide the productivity and cost-effectiveness MEI Mail & Document Management Services needed to expand offerings and meet higher volume demands
PV activities will continue to grow in volume and complexity. Trusting an experienced partner to help manage PV requirements can free your team to concentrate on patient efficacy outcomes.
The future of EHRs has been a topic of heavy discussion and debate. The world many anticipated coming from Electronic Medical Record (EMR) systems is beginning to take shape, but due to the limitations of many practice-and hospital-based systems it is not exactly the future everyone envisioned. By HK Bain, CEO, Digitech Systems
In the past a petrol station was all about fuel but with BP reporting half of its customers in the UK and Ireland are stopping for food not fuel and the recent introduction of electric charging stations and lockers for online pickup, it is clear consumers increasing demand for convenience is changing the sector. Adapting to the new trends, means new and existing customers will keep coming in using cash, card or mobile payments for their purchases.
Learn how SaaSOptics is able to provide clear financial visibility to steer a fast growth SaaS company, remove spreadsheet headaches and deliver efficiency, scale and real-time visibility.
The most effective way to stop opioid dependence is to eliminate the use of these addictive drugs after surgery altogether. This was the goal of Pacira Pharmaceuticals.
Yale scientists have created a new type of silicon laser that uses sound waves to amplify light. A study about the discovery appears in the online edition of the journal Science.
Last year, physicists at MIT, the University of Vienna, and elsewhere provided strong support for quantum entanglement, the seemingly far-out idea that two particles, no matter how distant from each other in space and time, can be inextricably linked, in a way that defies the rules of classical physics.
Researchers have shown that it is possible to train artificial neural networks directly on an optical chip. The significant breakthrough demonstrates that an optical circuit can perform a critical function of an electronics-based artificial neural network and could lead to less expensive, faster and more energy efficient ways to perform complex tasks such as speech or image recognition.
Pharma group MSD has announced plans for a new biotech facility in Dublin in a move that is expected to create 350 jobs.
Invuity, Inc. (NASDAQ: IVTY), a leading medical technology company focused on advanced surgical devices to enable better visualization, today announced it has entered into a definitive agreement with Stryker Corporation (NYSE:SYK), pursuant to which Stryker will acquire all of the outstanding shares of Invuity for $7.40 per share in cash, implying a total equity value of approximately $190 million.
