Industry Analyst Reports
Synergism principal Kelly Willenberg and Medidata vice president of data operations Lori Shields discuss and debate the key issues that divide sites and sponsors, and the new methods and technology that can offer near-term and lasting solutions in a Bio-IT World podcast.
Global Biopharm Solutions president Steven Jacobs and Medidata director of Balance Solutions Ehsan Ramezani discuss the changes taking place in the clinical trial randomization and supply management arena, as well as the available solutions that appear to address the ongoing challenges in a Bio-IT World podcast.
CEO & president of the Halloran Consulting Group Laurie Halloran and Medidata senior product director Steve Young discuss how clinical business analytics can help sponsors effectively mine the unprecedented amounts of data now available to clinical operations departments to make more informed decisions in a Bio-IT World podcast.
Senior research fellow at the Tufts Center for the Study of Drug Development Ken Getz and Medidata vice president of data operations Lori Shields discuss how increasing trial complexity affects trial success, how to anticipate and manage trial hurdles and how to motivate trial progress through metrics in a Bio-IT World podcast.
Medidata vice president of strategic regulatory initiatives Patricia Beers Block and senior product director Steve Young address questions on how today’s challenging environment is prompting study teams to explore the use of risk-based approaches to monitoring that do not compromise data quality. They discuss how limited resources can be directed more effectively to where they’re most needed and to the most critical review activities in a Bio-IT World podcast.
Medidata vice president of quality assurance Fran Nolan and BLCMD Associates president Dr. Barton Cobert address drug safety regulation challenges that the biopharmaceutical industry is facing in clinical trials and the emerging new technologies that can help researchers address them in a Bio-IT World podcast.
Medidata vice president of alliances Anne Zielinski and Monitor For Hire president Scott Freedman discuss how technology is altering the landscape for clinical monitors and impacting the success of clinical studies in a Bio-IT World podcast.
Medidata president Glen de Vries and SAS global director of health and life sciences market segments Jason Burke discuss the current state of health business innovation, particularly around providing solutions for clinical trials and drug development in a Bio-IT World podcast.
Senior research fellow at the Tufts Center for the Study of Drug Development Ken Getz and Medidata general manager of trial planning solutions Ed Seguine address the cause, not symptoms, of rising clinical trial delays and costs in a Bio-IT World podcast.
Clinical Trial Innovation Powered by the Cloud
For most companies, the cloud experience today centers on the use of Software as a Service (SaaS). While other cloud models—like Infrastructure as a Service (IaaS) and Platform as a Service (PaaS)—deliver value, SaaS is the cloud concept that is most visible and tangible. As compared to the traditional installed, on-premise software and even web-based and hosted software, the benefits of SaaS are profound and disruptive. This paper will explore how those benefits apply to clinical research sponsors.
Top 15 Procedure Benchmark Costs
This paper provides benchmark costs for the 15 most common study procedures. Site grants can constitute approximately 40 percent of a study’s overall costs. Built from the proprietary PICAS® database of benchmark trial costs, this informative report will help sponsors build study site budgets that are fair market value defensible.
IRT and EDC: The Unified Experience
This paper summarizes and discusses the challenges, advantages and future around integrating interactive response technologies (IRT) and electronic data capture (EDC) systems to streamline clinical development.
Capturing the Value of EDC
This paper looks at the evolution of EDC, the considerations and requirements of each process (paper vs. EDC) and the ROI companies can expect to see over multiple trials. It also attempts to explain reasons why some companies have yet to make the change, and delves into the future of these technologies and why making the switch is both wise and essential for all life science organizations, irrespective of size.
Why Monitoring Is More Than Just SDV
This paper delves into how Medidata's cloud-based tools support TransCelerate’s five recommended tactics for a successful risk-based monitoring program.
The Virtual R&D Operating Model: How Innovative Outsourcers Are Using Advanced Cloud Technologies to Collaborate with CROs
Today’s life science companies want to be better outsourcers, and they need solutions that support collaboration and compliance (for less than they were spending five years ago). This paper explores how sponsors can increase visibility into outsourced trial operations using advanced clinical trial management system (CTMS) cloud technology and data and integration standards.
Adopting Site Quality Management to Optimize Risk-Based Monitoring
In today’s pressure-packed environment, the quest for improved data quality at a lower cost is of paramount importance to all clinical organizations. A risk-based model for monitoring has become a growing and crucial component in this search. This white paper will break down the issues related to the implementation and tracking of a risk-based monitoring program.
Using Technology to Deliver Complex Oncology Trials
Accelerating the outputs of clinical research, identifying sub-optimal treatments quickly and refocusing efforts on treatments that look more likely to succeed are pressing goals of oncology R&D organizations. This white paper explores how advanced technology available today offers the efficiency, speed and data visibility to help yield these results for research organizations.