Government

WHITE PAPERS AND CASE STUDIES

• Women-Centric Approach To Clinical Trials

  Women are demanding more power, information, and control when it comes to their health. Learn how women now have a stronger voice when it comes to clinical research for treatments that impact their care.

• Considerations For Post-Approval Biologics Manufacturing

  Read about considerations before, during, and after clinical trials that can help you maintain the biologic drug approval status you have spent years working to achieve.

• Meta Biomed Accelerates Digital Transformation

  Meta Biomed's scientists ran hundreds of experiments, but they lacked a clearly defined way of sharing information and knowledge between individuals and teams. They also wanted to centralize their product development data and achieve a more structured way of working to boost innovation, embed quality throughout the supply chain and accelerate product certifications—especially as they sought to become a leading supplier of surgical sutures in the global market. A single, centralized database solution now allows them to hold all of their product development data.

• Cyberstates 2021: The Definitive Guide To The U.S. Tech Industry And Tech Workforce

  The tech workforce consists of two primary components, represented as a single figure by the ‘net tech employment’ designation. The foundation is the set of technology professionals working in technical positions, such as IT support, network engineering, software development, data scientist, and related roles. Many of these professionals work for technology companies (46.5 percent), but many others are employed by organizations across every industry sector in the U.S. economy (53.5 percent).

• Cybersecurity In Medical Device Development

  Security now needs a seat at the medical device design table, accompanied by its own list of requirements. Here are resources to identify specific areas to focus cybersecurity efforts throughout the product’s life cycle.

• Tekton Research Experiences A 'No Findings' FDA Inspection

  As COVID-19 increased its impact on research collaboration and monitoring in 2020, Tekton Research’s desire to move to full remote monitoring intensified. The research site soon realized there was a need for a remote source document monitoring solution --– one that would enable the upload, management and sharing of source documents with monitors and sponsors without redacting sensitive patient information.

• Network Infrastructure: Why A Single Global Standard Is The Only Way Forward

  In past centuries, communications network infrastructure included ships, foot messengers, pigeons, telegraphs. The world seemed much larger than it does today. Just as ships dominated global communications logistics back then, IT network infrastructure is now the central nervous system that transports data around the globe from data centers to businesses and consumers.

• When ‘Okay’ Data Protection Is Not Enough

  Contigo Technologies is a leading MSP based in Austin, Texas. While many MSPs focus on particular verticals, Contigo’s technical and service offerings have made them the “go-to” MSP for businesses across the Austin area. An example of their commitment to customer service is that they place an icon on every supported workstation that lets the user contact Contigo in a matter of seconds, whether to access support or just ask a question.

• Top Five Reasons You Need IRT Expertise (Not Just Software)

  Discover why pharma companies generally seek IRT vendor relationships to ensure high quality builds that meet their needs and avoid the potential pitfalls associated with RTSM.

• Brand Spirits Leader Digitizes Business Operations With The SIMATIC IT Suite

  Gruppo Campari closed 26 acquisitions in the spirits industry in the past two decades to become the world’s sixth player, with over 50 premium and super-premium brands. With each acquisition, Gruppo Campari needs to integrate new products, plants and assets into its operations management systems. By 2012 they realized there was no standard workflow for document authoring and validation, and information was shared via email or phone. Using Siemens technology, Gruppo Campari has created a unified repository for all product specifications and increased the efficiency of product development and manufacturing processes.

• Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

  Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

• Steps To Paperless Clinical Research Sites

  This paper presents insight and expertise on how investigative sites can begin the transformation to digital documents, including concrete, practical suggestions for eliminating the inefficiencies inherent in printing, storing, and managing paper documents.