Authors
Latest:
Information as a Strategic AssetUses for next generation information management, called health intelligence, in research.
Latest:
Information in Action: DIA's Barbara Lopez KunzWilliam Looney speaks with DIA's Global Chief Executive to see how the organization is repositioning itself.
Latest:
Beware of Costly ConsequencesNoncompliance with the US Foreign Corrupt Practices Act carries heavy penalties.
Latest:
Trials in Latin AmericaAn overview of the clinical research landscape in this emerging region that also looks at its challenges.
Latest:
Reducing the Data Burden for Clinical InvestigatorsClinical trials have changed significantly in the past decade with increasingly large and complex global studies. Multi-center, multinational trials are common, with complicated treatment protocols, large staffs, and huge data sets muddling the clinical trial processes. With years of development time and millions in R&D invested in a new treatment before it reaches the trial stage, there is incredible pressure on investigators to deliver quality data.
Latest:
Enabling Digital Transformation: Managing External Clinical Data Sources to Advance Drug DevelopmentWith an increasing amount of diverse data that must now be collected and analyzed, the industry is faced with increasingly complex studies that present new challenges in data management.
Latest:
Sunshine Act's ImpactThe amendment addresses data concerns for both physicians and drug/device manufacturers.
Latest:
Triggered MonitoringAmong the many clinical development processes that need to be conducted in a smarter, more cost-effective manner, clinical data monitoring stands out as a promising area in which operational efficiencies can not only reduce costs but also improve research quality and patient safety.
Latest:
Information as a Strategic AssetUses for next generation information management, called health intelligence, in research.
Latest:
Imaging CROs in AsiaImprovements in image acquisition and read quality: A look at the value of standardization in oncology trials.
Latest:
Simplicity is the Ultimate SophisticationHow one eClinical platform can create unparalleled efficiency in the future.
Latest:
Trials in Latin AmericaAn overview of the clinical research landscape in this emerging region that also looks at its challenges.
Latest:
Outsourcing to CROs: Expediting Clinical Operations or Oversight Nightmare?Simply handing off multi-million-dollar studies to CROs without carefully crafted plans for communications and reporting operational data as the study unfolds is hardly a wise move, yet what kind of oversight is needed? Live: Tuesday, Apr. 28, 2020 1pm EDT | 12pm CDT | 10am PDT On demand available after airing until Apr. 28, 2021. Register free
Latest:
A Ten Step Trial Crisis PlanToday's drug sponsors need to prepare and practice for worst-case clinical trial scenarios.
Latest:
Documenting Adverse EventsAnalysis of hematology and blood chemistry's AEs in sponsor's databases.
Latest:
EHR and EDC Integration in RealityAn evaluation of the Munich Pilot and the affects of the EHR-EDC integration solution.
Latest:
Interactive Informed Consent: Better Informed Patients, Better TrialsIn July, at a meeting called by the U.S. Department of Health and Human Services on Human Research Protections, I reviewed the fascinating results of a randomized study that recently compared paper-based informed consent to electronic informed consent.
Latest:
An Assessment of AdaptiveUnderstanding and using adaptive trial design to achieve the most of its available advantages.
Latest:
Language & Culture in Global Clinical TrialsWith more clinical trials conducted overseas, sponsors are facing new obstacles.
Latest:
EHR and EDC Integration in RealityAn evaluation of the Munich Pilot and the affects of the EHR-EDC integration solution.
Latest:
Late Phase Patient Reported OutcomesPatient-level feedback from later studies provides a multitude of valuable answers to all stakeholders.
Latest:
European Pediatric Informed Consent and AF: Current Status of Country RequirementsThe Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.
Latest:
The Quality CoachThe right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.
Latest:
Direct-to-Patient Enrollment StrategiesA comparison of the yields and costs of online outreach methods to other recruitment techniques.
Latest:
New Ways to Recruit Trial SubjectsTo minimize time to market, sponsors must explore new subject recruitment techniques.
Latest:
Medical Device TrialsUnderstanding the United States' regulatory pathways and clinical operations.
