Authors
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Three-Pronged Approach to Optimizing Trial MonitoringStudy results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.
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Improve the Business of ScienceCollecting too many metrics can lead to misappropriation and misinterpretation.
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From Cradle to GraveTracking the life cycle of a drug is a complex process that early planning and IVR technology can help ease.
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Biomarkers and Surrogate Endpoints in Clinical Drug DevelopmentBoth large and small pharmaceutical companies have learned that the value of their development candidates increases once clinical research has demonstrated their proof of concept. Sponsor companies face the challenge of moving new blockbuster drugs to market as rapidly as possible.
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The Business Behind Technology ChoicesBusiness needs and the processes built to support them are the driving force behind sound technological decisions.
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Identity Trust is a Must in Clinical Development CollaborationsIdentity trust platforms assure clinical investigators that their credentials are legitimate by allowing use of a single identity that can be recognized across multiple entities. These platforms support collaboration by allowing drug development participants to access data, sign and exchange documents.
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Promoting Clinical Trials in JapanLaunched in 2003, the LCN Project calls for more studies and an improved trial infrastructure.
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A Look at the Current State of SitesNew models such as IROs are changing the way industry views the current site landscape and addressing challenges.
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Reverse Auctions: Crusade or Curse?In this Web-based strategy, suppliers bid "down" prices for the privilege to sell their products and services. Is big pharma sold?
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When Should the Audit Trail Begin?A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
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Press One for SafetyIVR systems can capitalize on exposure data and analyze adverse events much earlier.
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The UK Freelance NetworkEconomic realities are changing the way companies do business. One significant change is the growing numbers of freelancers in the clinical trials arena.
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Manage Trial Master Files via Investigative PortalsAutomated eTMF solutions reduce costs, improve productivity, and enhance data management.
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Data Integration: Past & FutureEmerging technologies are moving the industry closer to true IT solutions harmonization.
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Recruitment Done RightHow a good plan and hot lunch can spell success for sponsors. Attention to detail can help boost dwindling subject enrollment and retention, saving both time and money.
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CDISC Standards: Enabling Reuse Without ReworkA single, industry-wide standard could streamline the clinical trial information management process.
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Press One for SafetyIVR systems can capitalize on exposure data and analyze adverse events much earlier.
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Laying with the LionsBig pharma collaborates on routine audits and quality management of third-party service providers.
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Leveraging a Unified Data Model to Drive Collaboration and Clinical Trial EfficiencyThis article will focus on a case study example of a collaborative effort to share investigator, site, and study information across companies, and on the single data model that underpins it.
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Health Economics & Analysis in Clinical DevelopmentIncreased cost concerns set the stage for health data to play a major role in drug development.
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Approaching AfricaThe Declaration of Helsinki requires that control groups receive the “best” current treatment, not the “local” one. This shift in wording has profound implications.
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Health Economics & Analysis in Clinical DevelopmentIncreased cost concerns set the stage for health data to play a major role in drug development.
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The Quality CoachThe right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.
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Increasing Study Sensitivity in Early TrialsHow using eDiaries in Phase II can increase power while reducing subject size and costs.
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EHR & EDC: Tomorrow's Technology TodayA review of important factors to consider before implementing the solution that will transform EDC.
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Meet the EAB: John VogelJohn Vogel, clinical researcher turned consultant, is passionate about outsourcing. He believes that pharmaceutical companies can gain competitive advantages through drug development outsourcing.
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Health Economics & Analysis in Clinical DevelopmentIncreased cost concerns set the stage for health data to play a major role in drug development.
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MA Bio Industry Perseveres and EvolvesMassBio president Dan McDonald discusses Massachusetts' bio industry and its ability to continually evolve despite the economic downturn.
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An Ideal SOP SystemA "can’t live with them, can’t live without them" attitude is revealed in survey of standard operating procedures in the management and conduct of clinical trials.
