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How Speech-Based Digital Biomarkers are Redefining the Measurement of Disease Progression in Neurodegenerative Dementia TrialsFuture shows great potential for neurological language assessments in clinical trials.
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Direct-to-Patient: At-Home Clinical Trials Are Here to StayThe success of the decentralized model hinges on coordination between stakeholders across the supply chain to ensure that date is secure, medication is delivered on time, and in proper condition.
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Investigative Site Placement Practices to Support Operation Warp SpeedComparing late-stage COVID-19 vaccine trials to historical practices.
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Strategies to Fill Gaps in Patient Recruitment and Enrollment eBookThe patient recruitment and enrollment funnel is an overlooked pain point in clinical research. OneStudyTeam addresses inefficiencies in this stage, along with opportunities and strategies for improvement.
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Navigating New Changes During the PandemicCOVID-19 reshaping the roles of CRAs overseas as industry shifts to remote monitoring.
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Establishing a Basis for Secondary Use Standards for Clinical TrialsStudy seeks to understand how different forms of data meet the needs of researchers.
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The Nuances of Patient Selection: Why Some Trials Need Eligibility AdjudicationPatient selection can be a nuanced process in clinical trials, particularly those involving therapeutic areas with more complex or subjective inclusion/exclusion criteria. Determining patient eligibility may often depend on factors that require clinical expertise in such areas as disease progression, comorbidities, genetic mutations, and disease severity. Discover the role eligibility adjudication committees play in ensuring trial success.
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Balancing the Three-Legged StoolREMS are new only in name. The basic concept has long been central to drug regulation.
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Top 5 Mistakes of RFP WritingKnowing what you want from a CROs proposal will help make the most of the selection process.
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Key Factors in CRO SelectionA recent survey uncovers key criteria that influence a sponsor's decision when selecting a CRO.
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Outsourcing's Evolution from Commodity to PartnerCan the historical industry and vendor service relationship change to one where both parties benefit?
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Key Factors in CRO SelectionA recent survey uncovers key criteria that influence a sponsor's decision when selecting a CRO.
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eProposals: An Interactive Approach to eProcurementA more transparent solution to vendor selection in an evolving technology environment.
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Pediatric Research in GermanySurveys among pharma, clinics, and investigators shed light on trials in children.
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Strategy FirstAn integrated product development plan designed early increases the odds of on time success.
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Strategy FirstAn integrated product development plan designed early increases the odds of on time success.
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Business and People Update July 2008Industry news focusing on the people and organizations who work in the clinical trials profession.
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A New Phase in MedicineHow the merging of medical faculty and academic hospitals in The Netherlands is improving the country's research infrastructure.
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Business and People Update February 2010Industry news focusing on the people and organizations who work in the clinical trials profession.
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Pediatric Research in GermanySurveys among pharma, clinics, and investigators shed light on trials in children.
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Steps to Functional Service Provider SuccessOutsourcing fundamentals for this pick-and-choose model so that both sponsors and service providers win.
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Making Medical Writing a PriorityFinding a strategic approach to writing clinical study reports.
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'Fit-for-Purpose' Considerations for Remote TrialsQ&A with Joachim Lövin explores the challenges and lessons learned in boosting the flexibility of conducting decentralized clinical trials post-COVID.
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ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.
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Predicting the Probability of Success in Clinical Drug DevelopmentUndertaking an assessment of the POS can be coupled with the product profile and safety assessments of compounds prior to launching a clinical trial.
