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Articles
CLINICAL TRIALS – Why Are Metrics Important in Starting Clinical Trials? January 8, 2018
Craig Morgan believes metrics are indeed critical to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages.
Medrio, Inc. & PHASTAR Unite to Offer Data Visualization for Clinical Trials September 8, 2021
Medrio and PHASTAR recently announced they have partnered to leverage metadata surrounding electronic patient-reported outcomes (ePRO) for advanced data visualization, providing insight into….
CLINICAL TRIALS – Considering Recurrent Events in Clinical Trials Statistical Analysis March 29, 2021
Jennifer Rogers discusses how non-fatal recurring events, such as asthma attacks, epileptic seizures, and hospitalization for heart disease, have a certain manner in which they should be handled in clinical trials.
CLINICAL RESEARCH – Behind the Wave: Clinical Research in a Digital Transformation Era May 1, 2017
Kai Langel believes the remote research model and purpose-built technology offer the tools and the right process to help modernize clinical research and bring it closer to the high standard set by today’s consumer technologies.
CLINICAL TRIALS – It’s Time to Revamp the Unsexy Plumbing of Clinical Trials April 3, 2017
Craig Morgan says as clinical trials continue to evolve, drug companies will no longer be able to rely on existing, tried-and-tested manual methods or point solutions for success. And technology integration in the eClinical stack is not sufficient to bring about the step change in productivity that has to happen.
CLINICAL TRIALS – Outsourcing Early-Stage Clinical Trials: How to Mitigate Costs & Risk June 3, 2014
Roundtable Discussion: Contributor Cindy H. Dubin gathered leading CROs together to discuss the benefits of outsourcing early-stage clinical trials, how to mitigate the risks, and lower costs in the process.
SPECIAL FEATURE – Injection Devices: Three Trends Influencing Development & Delivery September 1, 2022
Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.
BIOMARKERS – Biomarkers: The Guiding Light for R&D in Heterogeneous Diseases January 14, 2022
Thomas Turi, PhD, says while biomarkers have been a long-standing part of R&D and a mainstay of clinical practice for the characterization and diagnosis of disease for decades, they are increasingly playing a crucial role in guiding decisions to improve efficacy and efficiency of clinical trials.
OSD FORMULATIONS – Dissolving Bioavailability & Solubility Challenges in Formulation & Development September 30, 2020
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules June 4, 2020
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
Leading BioSciences Announces Potential for Investigational Drug to Treat Multiple Organ Dysfunction Syndrome in COVID-19 Patients April 9, 2020
Leading BioSciences recently announced it has developed a potential approach to treat COVID-19 patients suffering from acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS) using its….
GENE & CELL THERAPY – Its Growing Potential to Disrupt Drug Research & Healthcare Delivery October 2, 2017
Jeff Galvin believes as the pace of gene and cell therapies accelerates over this next decade, potential cures for chronic diseases, cancer cures, and autosomal defect cures will result, and the efficacy of new therapeutics may move as much as $500 billion from traditional pharmaceuticals to gene technologies.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise April 2, 2014
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.