E-Signatures and Digital Workflows in Clinical Trials
In clinical trials, the use of eSignatures to improve document workflows such as protocols, informed consent, and investigator brochures, has increased. All documents that need signed approvals eSignatures can be implemented to streamline, improve and make the transferring of those documents more efficient. This podcast discusses areas in clinical trials where eSignatures and document workflow can be applied for upstream benefits.
Turning Signals into Action: A New Model for Risk-Based Monitoring
The practice of Risk-Based Monitoring (RBM) has been gaining in popularity for many years, but the full potential of RBM has yet to be unlocked. A new framework, driven by advanced information technology and machine learning, integrates systems such as electronic data capture with advanced RBM tools, helping researchers go beyond the mere identification of risk to enable immediate action. In this podcast, we’ll explore how a signal-driven approach can empower efficient, informed decisions that dramatically improve trial safety, quality and compliance – in a way that is traceable and auditable.
The Power of Clinical Partnerships
Zaher El-Assi, President of Merge eClinical, shares lessons learned and the core practices his company uses to forge long-term partnerships that produce value for both companies that goes beyond the traditional buy-sell relationship.
How Information Technology is Leveling the Clinical Research Playing Field
Zaher El-Assi, President of Merge eClinical, discusses the development and application of current and emerging technologies in clinical research.
Cenduit Quickcast - Improving Patient Compliance
Host Lex Raleigh talks with Mark Taggart about challenges site staff face and solutions to decrease recruitment costs and increase patient retention, adherence, and compliance.
Challenges in Oncology Trials in Ontario
Karen Arts, is the Director of Business Development, High Impact Clinical Trials Program at the Ontario Institute for Cancer Research in Toronto, Canada discusses challenges in oncology trials in Ontario with Roberto Lara, Director of Business Development for Scimega Research.
How Effective Resource Planning Reduces Study Cost and Risk
Join Lisa Henderson, Editor in Chief of Applied Clinical Trials, and Molly Blake-Michaels, Senior Director, Clinical Services at ClearTrial, as they discuss how leading sponsors are significantly improving their resource planning for clinical studies.
Making Preferred Provider Relationships Work
Join Lisa Henderson, Editor in Chief of Applied Clinical Trials, and Mindy Davis, Senior Director, Clinical Services at ClearTrial, as they discuss the challenges and benefits of preferred provider relationships being formed between study sponsors and their CRO partners.
How to Avoid 5 Common Project Management Mistakes in Clinical Trials
Join Lisa Henderson, Editor in Chief of Applied Clinical Trials, and Rachel Yagur, Manager, Clinical Services at ClearTrial, as they discuss how leading sponsors are applying best practices in planning and communication to avoid common project management mistakes in clinical trials.
Montrium CEO Paul Fenton Discusses the Need for Electronic Document Workflow
Paul Fenton, President and CEO of Montrium, on how electronic workflow changes business process and brings efficiencies to eTMP, eCTD, and overall document awareness.
Greenphire CEO Sam Whitaker Discusses the Financial Pain Points for the Investigative Site, and How to Solve Them
Sam Whitaker, CEO of Greenphire, discusses the company’s success to date with its financial payments technology, global capabilities for next year, and how financial pressures are changing trials for the better.
Parexel's Ethnobridging Expert Discusses Its Importance as a Development Strategy
Stan Jhee, PharmD, Senior Director of Research, Early Phase at Parexel, defines the importance of ethnobridging in clinical trials, and how it works as a drug development strategy for pharmaceutical companies.
CER and Personalized Medicine: Insights from the Experts
Kathy Wyrwich, Senior Research Leader, Outcomes Research, United BioSource, shares insights on comparative effectiveness research and personalized medicine with discussions she had with stakeholders from Pfizer, Duke University School of Medicine and Medco Research Institute.
INC's CEO Discusses the Current CEO Climate
Jim Ogle, CEO of INC Research, offers his take on industry consolidation, what it means for the future, and INC’s own role and strategy in its recent acquisitions.
Shire's Move from R&D to Search and Development: An IT Perspective, Part II
In part 2, Charlie Dougherty, Director of R&D IT for Shire Specialty Pharmaceuticals, discusses technology changes in the next five years and how Shire is leveraging externally hosted environments and the cloud to address its search and development strategy.
Shire's Move from R&D to Search and Development: An IT Perspective, Part I
Charlie Dougherty, Director of R&D IT for Shire Specialty Pharmaceuticals, discusses leveraging externally hosted environments and the cloud to address the pharma R&D group of the future.
Web Solutions Can Improve Document Exchange
Linda Bowers, Vice President Life Sciences Product Marketing for IntraLinks, discusses study start-up bottlenecks and how they can be addressed by sponsors using technology to move beyond paper trails..
Applying the Principles of Lean Process Improvement to More Effectively Manage Study Close-out Inventories
Sponsored by Aptuit
Esther Sadler-Williams and Kenneth Strømdahl discuss how the principles of lean process were applied to improve management of inventory closeouts that occur at the end of clinical trials.
Proven Methods for Reducing Change Orders and Assessing Their Impact
Sponsored by CleartTrial
Listen to how forward-thinking biopharmaceutical and medical device companies are reducing change orders during clinical trials – and how they are managing change orders more effectively when they do occur.
Global Trial Considerations
Sponsored by MDS Pharma Services
eCTD: Learn from Early Adopters
Implementation of the electronic Common Technical Document or eCTD is still early on the adoption curve within the pharmaceutical industry. Regulatory professionals will be interested to hear the insights from participants of an eCTD Early Adopters Roundtable sponsored by Applied Clinical Trials and Clarkston Consulting.
Early Phase Patient Studies
Join Lisa Henderson, Editor in Chief of Applied Clinical Trials, and Gerd Arold, MD, Senior Director Scientific Affairs, Patient Pharmacology, Early Development Services at PRA, as they discuss Early Development Services, and market requirements for Early Phase Patient Studies.