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No-Brainer Provisions of the 21st Century Cures ActThe 21st Century Cures Act, passed in December, contains provisions that many have questioned and criticized. This review of those provisions shows that progress in this sector is being made.
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Malaysia’s Clinical Research EcosystemExamining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.
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Malaysia’s Clinical Research EcosystemExamining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.
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Cancer Moonshot 2020: Next Generation Standard of Care for CancerThe war on cancer has seen significant strides made in the search for a cure, however, recent data suggests that the work is far from over.
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MythBusting: 6 eConsent Myths we Need to Correct in 2018Debunking the six most common myths regarding electronic informed consent.
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A Practical Overview of Patient-Centric TrialsA how-to guide for clinical trial managers in implementing patient-centric approaches using today’s clinical study model.
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A Practical Overview of Patient-Centric TrialsA how-to guide for clinical trial managers in implementing patient-centric approaches using today’s clinical study model.
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We Need a Next-Generation RBM Approach TodayThe pharma industry needs an improved risk-based management approach to better handle the increased complexity of trials, to improve the quality of studies and to better adhere to new guidelines from regulatory agencies.
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Investigator Engagement: The Key to Solving the Clinical Trial Enrollment CrisisSponsors have been addressing the problem with initiatives designed to find, attract, and retain patients in clinical trials more effectively.
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How to Simplify Site Tasks and Help Ensure Dispensing AccuracyClinical technologies have the ability to streamline the daily processes of site staff and insure a more efficient clinical trial.
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How to Simplify Site Tasks and Help Ensure Dispensing AccuracyClinical technologies have the ability to streamline the daily processes of site staff and insure a more efficient clinical trial.
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Rapid Study Startup: Streamlining Trial Site ActivationThe redundancy of process and documentation for activating trial sites has been an issue in the past as it can lead to delays in trial initiation. Rapid study startup can illuminate these inefficiencies by removing or reducing non-value tasks.
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An Economic Evaluation of Clinical HomecareExamining the cost and patient recruitment and retention benefits of bringing clinical research procedures to the subject’s home.
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An Economic Evaluation of Clinical HomecareExamining the cost and patient recruitment and retention benefits of bringing clinical research procedures to the subject’s home.
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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.
