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Strategic Comparator SourcingEffective ways for sponsors to reduce risk when embarking on comparative clinical trials.
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Letting Investigators LeadPerspectives on adoption of technology at U.S. Academic Medical Centers and how sponsors will be impacted.
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Preapproval OpportunitiesIntegrating clinical trials and named patient programs to provide global access to drugs before approval.
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Can We Predict Drug Efficacy with Artificial Intelligence?Approaches such as machine learning, AI and neural networks are still in their infancy, but with AI companies rewriting the code for drug discovery, the implications in pharma are likely to be far ranging in the coming years.
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Forecast Enrollment Rate in Clinical TrialsInstinctively, when there are more investigators/sites being deployed for a trial with a defined number of patients needed, we should expect shortened enrollment cycle time. This sounds right, but is it really?
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Strategy FirstAn integrated product development plan designed early increases the odds of on time success.
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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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Objective Internal MonitoringSponsors are responsible for monitoring studies, patient safety, and data integrity.
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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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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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Evaluating the Effects of Therapy MaskingUsing a specific trial, the importance of assessing the success of therapy masking is examined.
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Cost and Quality Implications of RBMThis is the third post in a three-part series on quality implications of RBM.
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Small Biopharm Firms Struggle to Meet Development ChallengesThe temptation to use uncontrolled, early, small studies to support further development of products may prove problematic for emerging biopharma companies.
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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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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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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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Promoting Clinical Trials in JapanLaunched in 2003, the LCN Project calls for more studies and an improved trial infrastructure.
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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.
