Government

WHITE PAPERS AND CASE STUDIES

• High-Quality, Audit-Ready Clinical Research Driven By Digital Data Management

  A contract research organization (CRO) focused on quality needed to more thoroughly document clinical studies for sponsors, regulatory authorities and other auditors. With a cloud-based, unified IBM® Clinical Development platform, the CRO can now quickly create accurate digital records of every action taken, including granting users access and updating study protocols.

• Food Safety And Quality Regulations: A Guide To Global Standards

  There are many food safety standards impacting individual companies. Depending on the location and business type, a manufacturer may be guided by dozens of standards, regulations and/or laws.

• 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.

• Patient-Centric Trials: Overcome Enrollment Challenges By Putting Patients First

  Just as patients have a stronger voice in today’s healthcare marketplace, that voice should resonate earlier in the drug development process. By adopting a patient-centric approach during protocol design and in day-to-day study management, sponsors can expect improved patient enrollment and retention, as well as a cleaner study with definitive outcomes.

• Best-of-Breed vs. ERP For Field Service

  Field service organizations have two broad choices in field service management software — best-of-breed solutions or add-on models from their ERP or CRM vendors. ERP options promise ease of integration, but  best-of-breed FSM solutions offer advantages in terms of long-term cost, functionality, and integration.

• Leveraging Predictive Analytics: A Case Study

  Often the first notification of a spill comes from a member of the public, hours and sometimes days after the first spill. This can intensify public health and environmental impacts and the cost of clean-up efforts. Following a sewer spill at an environmentally significant site at Midway Point in August 2017, TasWater sought a way to reduce the likelihood and impact of spill events occurring in the future.

• Practical Considerations Of A Successful RBQM Implementation

  Advances in technology, such as electronic capture and storage of study data and documentation, have accommodated the growing reliance on RBQM for clinical trials. With any new technology, there are questions about implementation and best practices.

• Customer Messaging: Happy Customers, Better Results

  This report will highlight the business value companies observe by using messaging in customer service activities. We’ll also illustrate several building blocks companies must put in place to reap maximum results from investing in messaging.

• A New Era For Water Management: How Experts See The Future After Coronavirus

  The world crisis generated by the coronavirus opens up a scenario of uncertainty for utilities. They must undergo a process of change to guarantee water supply without compromising the health of their employees and clients.

• ChromoReport Spring 2020: Machine Learning Predictive Models

  Clinical operations staff need to have confidence in machine learning predictive models and be able to validate the accuracy of outcomes. By knowing which indicators have the most impact on these models, organizations can focus on those indicators to refine their models and learn from these insights, which can ultimately drive behavioral changes (i.e., less reliance on subjective decisions) to optimize business processes.

• 505 (b)(2) vs. ANDA: How Complex Drugs Fit In

  Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

• Mapping The New Landscape Of Orphan Drug Development

  The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.