Government

WHITE PAPERS AND CASE STUDIES

• How To Avoid Last Minute CMC Roadblocks To Approval

  Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.

• Virtualizing Clinical Trials

  The backbone of drug and medical device development is the clinical trial process. A trend is emerging toward greater patient involvement in clinical trials — making them more patient-centric. Explore examples of real-world experience with clinical data collected by the patients themselves.

• Embracing Innovative Designs In Early Phase Oncology Trials

  Advancements in science and technology, combined with unmet patient needs, are driving accelerated timelines and creative pathways for oncology drug development.

• 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?

• The Service Model Evolution

  Today’s field service teams are very different than teams of the past in terms of how they’re formed, how they operate, their everyday responsibilities and more. Advances in technology, travel and society fueled this evolution for decades. Then, after the dot-com boom and the economic downturn of 2008, more changes occurred when organizations of all kinds earnestly challenged themselves to do more with less. Most recently, the COVID-19 pandemic hit and everything changed again; in many ways, we’re still in the midst of assessing how our world is different than before and how teams need to evolve to streamline operations and best serve customers and end-users.

• Is The Cloud A Safe Place For Your Data?

  Learn how life sciences organization can ensure integrity and security in a saas environment. Demonstrating data integrity and regulatory compliance is vital in the Life Sciences industry, and as technology evolves, these processes must evolve with it. This whitepaper explores the challenges these changes pose, and how to face them head-on.

• State Of Field Service Guide: Strengthen Your Field Service Management Strategy

  Get expert tips based on insights from 4,000 global field service decision makers. Companies are relying on field service for growth more than ever. To compete in today’s economy, leaders are building new field service strategies that accelerate innovation and revenue.

• 4 Machine Learning Use Cases for Clinical Trials

  Want to optimize your clinical documentation processes, promote effective TMF automation, and improve the overall process efficiency with machine learning (ML) technologies? Here are four business cases where ML can help you approach TMF documentation processes with greater efficiency, timeliness, and quality.

• Cleaning Up IT

  Williams Janitorial had been using a local company for both their accounting software and hardware setup and support since 1985. Recently, the owners retired, and the hardware and IT components of the business were sold to another company. It was then that Hobbie decided that rather than sticking with a solution they were familiar with, it was time for a change.

• 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).

• 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.

• Why The Field Service Landscape Is Changing

  There are three key considerations that field service organizations must take into account when building a modern workforce, including the changing demographics from Baby Boomer to Millennial, the impact of technology on field service operations, and the growth of the ‘gig’ economy. These three areas present significant opportunities and challenges for field workforce management today and in the future.