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Spotlight on Open-Label Extension StudiesOpen-label extension (OLE) studies are common, but they do not receive as much attention as traditional Phase I through Phase IV studies. Enrollment into an OLE study typically follows enrollment into a randomized, blinded, well-controlled main study. Participants are usually informed at the time they are recruited into the main study that they may elect to enroll in an OLE study after completing the main trial. The stated objective of most OLE studies is to obtain long-term safety and tolerability data.
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Waive Inclusion and Exclusion Criteria?Waiving inclusion/exclusion criteria affects investigators, subjects, sponsors, and the trial itself.
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Regulatory Considerations for Digitally Driven TrialsTech companies entering space must adapt and adhere to regulations set by FDA.
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Mastering Currency FluctuationStep-by-step process for budgeting global trials that uses a Currency Risk Management method.
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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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Paperless Clinical Trial Optimization—Thinking Outside the BoxThe implementation of best practices for clinical study and development conduct can streamline administrative burdens for investigator staff as well as study teams, and hopefully yield reduced costs in conducting global clinical development.
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Financial Simulation ModelingWith a PC and some software you can generate realistic projections that save time and money.
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EHR and EDC Integration in RealityAn evaluation of the Munich Pilot and the affects of the EHR-EDC integration solution.
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Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
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The Face of Partnering in IndiaHow leveraging local expertise can make the migration east smoother for companies.
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Engaging with Emotions: Patients as PartnersInvolving patients more meaningfully in the industry's activities means getting more serious about their emotional wellbeing.
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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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Biomarker BoomA look at the different testing methods and how the results impact drug development.
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Introducing PALADINFirst-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
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Adaptive Designs: A Fad or the Future of Clinical Research?Making adaptations to clinical trials in the early stages of research with the use of interim data.
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Critical Appraisal of Clinical Quality Assurance Based on Benchmarking Results: Past - Present - FutureA follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.
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East vs WestHow cultural and training differences affect molecular-based clinical research in China.
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Three Generations of RTSM (Randomization and Trial Supply Management)With all the focus on various data capture solutions in the clinical trials world over the past decade(s), few people seem to have noticed the exponential advances made in the real workhorse systems of the trials: RTSM. Also known as IVR, IWR and IRT, these systems actually execute randomization, blinded supply and resupply management to depots and sites, and most importantly of all, drug dispensing. Is there anything more important to get right?
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Adaptive Designs: A Fad or the Future of Clinical Research?Making adaptations to clinical trials in the early stages of research with the use of interim data.
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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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Pharma Casts Out Financial FunctionsOutsourcing finance and accounting can provide cost savings and improve operations.
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Pediatric Research in GermanySurveys among pharma, clinics, and investigators shed light on trials in children.
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Risk Based BudgetingAdoption of the concept of Risk-Based Budgeting could help maintain the trial budget or even save the whole clinical trial.
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How NLP Surfaces Adverse Events and Safety Insights to Improve Drug Safety ProcessesUse cases show benefits of unlocking data to improve signal and adverse event detection.
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Three Must-Dos for Tracking Research and Development of Monoclonal AntibodiesThere is an expanding array of potential antibody-based treatment options, such as bispecific or multispecific antibodies, that show promise in addressing conditions such as cancer, engineered antibody fragments, or even antibody-drug conjugates.
