Authors
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TMF Reference Model Opens 2017 SurveyThe TMF Reference Model has released a survey for industry professionals designed to provide insight for both paper and electronic trial document management.
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Patient Engagement and Advocacy: Advancing the Cause of Clinical Drug ResearchFor years, Duchenne muscular dystrophy drug trials included a specific endpoint requiring that they enroll only patients who were still able to walk. That changed when a DMD-focused advocacy organization took the matter up with the FDA and helped develop new trial guidelines.
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Rare Diseases Don't Feel So Rare to MeWith sixty million Americans and Europeans diagnosed with one or more of 7,000 defined rare diseases, the availability of treatments has been less than expected.
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Packaging, IT and Cold-Chain Logistics Advances for the Future of Medicine and Clinical TrialsLogistics can have a direct and measurable scientific impact on development, clinical performance and commercialization success of advanced drug therapeutics.
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The Growing Role of Performance Incentives Between Sponsors, CROsThe expanding role of incentives is a healthy trend in an industry defined by high costs and the pressure of deadlines, and such agreements have evolved recently to benefit all involved.
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Introduction to Cloud Computing for the Analysis of Large Human DatasetsThe economics and power of the cloud will drive its increasing adoption by pharma organizations for the foreseeable future as research becomes more data-intensive.
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Surveying the State of eConsent: Are There Still Barriers to be Broken Down?A recent eConsent survey reinforces the notion that this tech innovation is the next clinical trial solution the industry will adopt.
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Exploring the Future of Clinical Research for Immune-Mediated Inflammatory DiseasesIn the search for more effective treatments and cures, there are challenges that sponsors and CROs must confront when conducting IMID clinical trials.
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Exploring the Future of Clinical Research for Immune-Mediated Inflammatory DiseasesIn the search for more effective treatments and cures, there are challenges that sponsors and CROs must confront when conducting IMID clinical trials.
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Putting Safety at the Center of Clinical StudiesFor several decades, life sciences companies’ clinical development of products has focused predominantly on efficacy and specific mechanisms of action to drive efficacy forward. But as competitive pressures intensify and demands by patients and regulators for better-tolerated drugs increase, progressive companies are exploring safety as a product differentiator during the clinical trial process. Cheryl Key explores that development.
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Challenges in Medical Coding - Concomitant Medication Therapy Data in Clinical TrialsIn Case Report Forms data regarding Concomitant Medication, therapies can be presented in multiple ways. Medical coding is a common task that can ensure the consistency of the captured data.
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New Approach to System ValidationConsiderations in implementing a risk-based framework for computer systems validation.
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Aligning Data Entry and Site Payment Incentives For Clinical Trials and PatientsWith recent reports indicating that organizations do not have a way of tracking and managing the timeliness of data entry or of site payments, The Metrics Champion Consortium wanted to see if there were opportunities to align incentives in the industry so that both sites and sponsors can achieve their goals with positive impact on clinical trials and patients.
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M&A in the Pharma IndustryOrganizations are seeking growth and competitive advantage through mergers and acquistions.
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IDMP: An International Standard for Lifecycle Data ManagementThe implementation of the International Organization for Standardization identification of medicinal products (IDMP) is a key step to ensuring that information on new innovations are identified and captured accurately within the regulatory framework and beyond.
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Collaboration On EU’s New Clinical Trials Rule Brings Opportunity, ChallengesApplication review will require closer cooperation between ethics committees and competent authorities in several areas.
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Academic Research Under the Clinical Trial Regulation – Partial Relief?This article describes the experiences of the Medical University of Vienna with the Directive 2001/20/EC (CTD) regarding academic clinical research and reflects on the changes introduced by the Regulation (EU) 536/2014 (CTR).
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The Regulatory Debate Around Pre-approval Product AccessOutlining current regulatory issues and views surrounding expanded access to investigational products in the U.S.
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Why Real-World Studies Need a Lighter TouchWhy taking a right-sized approach to real-world studies will help keep sites and patients around for the duration.
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Why Real-World Studies Need a Lighter TouchWhy taking a right-sized approach to real-world studies will help keep sites and patients around for the duration.
