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WHITE PAPERS AND CASE STUDIES

• 9 Pitfalls To Avoid During The Document Control Process

  In order for the document control process to be a smooth ride to a successful product launch, you need effective control in every phase of the life cycle of every important document. In this white paper, we discuss common issues in every phase of the life cycle of a document.

• Xylem’s Energy-Efficient Technology Helps Top 100 Hospital Maintain Award-Winning Standards

  Geisinger Medical Center in Danville, Pennsylvania, is a high-quality health care facility that provides services to over 2 million residents on a yearly basis. The medical center was recently named a Thompson Reuter’s Top 100 Hospital as well as a Magnet hospital by the American Nurses Credentialing Center. A Magnet hospital designation identifies the top 5% of hospitals with programs aimed at the highest quality patient care and professional nursing performance. With top physicians in every field, and some of the most advanced technology in the country, Geisinger Medical Center has become one of the most respected hospitals in the U.S.

• Texas Cardiology Research Department Transforms Document Access, Fuels Productivity

  What drives an established and experienced clinical research site to completely transform the way they manage regulatory and trial documentation? For South Texas Cardiovascular Consultants, PLLC (STCC) it wasn’t just about paper, it was about what paper forced us to do.

• Global Pharma Company Dramatically Improves Collaboration, Communication, And Compliance In Trials

  A Top 5 global pharmaceutical company wanted to help sites do everyday tasks more efficiently, making it easier for site staff to adhere to the protocol and deliver high-quality data. After evaluations and pilots, the company deployed IQVIA Technologies’ Investigator Site Portal (formerly DrugDev) in a 4-phase approach that delivered benefits each step of the way.

• 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.

• Braving The Complexities Of Immuno-Oncology Trials

  Immuno-oncology trials are increasing in prevalence and, for many reasons, are much more complex than standard clinical trials. Learn how partnering with an experienced central lab can alleviate these challenges, create efficiencies, and save researchers time and expense.

• Beyond The Paper Binder: Comprehensive Cancer Centers Of Nevada Adopts Remote Monitoring

  Explore how Comprehensive Cancer Centers of Nevada (CCCN) modernized its regulatory documentation practices to enable remote site monitoring and improve efficiencies.

• A New Approach To Cell Sorter Safety

  Cell sorting continues to be a powerful contributor in the quest to improve human health, allowing researchers to make timely advancements in drug and vaccine development. However when cell sorters are run at high pressures, they can produce aerosols with high particulate content as well as extremely small particles. While several newer sorters include systems to address this concern they continue to resemble an ad hoc solution with manual operation of air-handling controls and poor access for service manipulation, which can lead to inconsistent results and an unsafe environment. In this paper we review a cell-sorter with a design to solve these problems.

• Advanced Control Technology For Laser Material Processing

  Simple, fast, accurate, and flexible control in laser materials processing; how to make it easier for system integrators to design and build advanced systems for a new age of laser applications.

• The Michael J. Fox Foundation For Parkinson’s Research Works With Service Provider To Remove Reimbursement And Travel Obstacles For Clinical Study Participants

  In 2010, MJFF launched a large-scale clinical study conducted at a network of clinical sites around the world focused on identifying and validating Parkinson’s disease biomarkers. The study realized it needed a new way to ensure that participants were remaining engaged throughout the long protocol and that the experience was as seamless as possible for both the volunteers and the site coordinators. They were able to source a solution to support patient-centricity, as well as study site efficiency.

• Innovative Recruitment And Retention Strategies For Phase III Rare Cardiovascular Disease Study

  A Phase III, placebo-controlled, double blind, randomized clinical study of pulsed inhaled nitric oxide targeting rare cardiovascular disease was facing challenges. A partnership helped them solve their issues with patient recruitment, organizational effectiveness and regional patient expertise.

• Preparing Clinical Trial Documents For Europe’s New CTIS

  Are you ready for the new Clinical Trial Information System (CTIS)? With European Clinical Trial Regulation (EU-CTR) 536/2014 set to go into effect in January, all stakeholders will be required to submit study information through CTIS. Be prepared with these best practices.