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Risk-Based ApproachesThe eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.
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Risk-Based ApproachesThe eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.
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Integrating Managed Access Programs: Global ConsiderationsMAPs can effectively address unmet patient needs and become a cornerstone of product strategy.
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Warning Letter StudyAn analysis of warning letters and the findings reported from 1996 to 2010.
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Cracking the Code on Study Start-UpNo matter how long you?ve been in the clinical trials business, the mantra is always the same: not enough investigators, not enough patients, enrollment falling behind, need for rescue sites, study budget overspend.
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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.
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Everything You Need to Know About Imaging Analytics For Clinical TrialsThe image acquisition and analysis components of R&D and clinical trials can be quite complex...
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Leveraging Technology to Bridge Clinical Trial Processes and Real-World Health CareBuilding upon the usage of technology in health care delivery, integrating technology into clinical research as a care option will be a game changer in achieving greater participation in clinical research and decreasing the overall time for trial completion.
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Competitive Pressure for First-in-Class Drugs is IntensifyingStudy shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.
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Modernizing Data Management in the D-Clinical Age***Live: December 9, 2020, at 11am EST| 8am PST| 4pm GMT| 5pm CET*** In this ‘D-Clinical Age’, leveraging modern technologies and new approaches and mind sets is required to accelerate the development of new treatments. This webinar will examine how data management can drive digital transformation with the right mix of technology, skills and process redesign.***On demand available after airing until Dec. 9, 2021.***
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PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
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Developing Quality BiosimilarsBiosimilars are a steadily growing new field of biopharmaceutical development and clinical research.
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Data Management Efficiencies Through Risk-Based Approaches and InnovationsBecause of drastic changes in the clinical trial space, there is a need for advancing and streamlining design through risk-based methodologies and innovations.
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Drivers of Patient Interest in ReferralAnalysis suggests age, condition, and treatment satisfaction have most significant effect on participation.
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Enrollment: More Than NumbersPartnering with CROs and using a blinded independent central review can increase trial success.
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Medical Device TrialsUnderstanding the United States' regulatory pathways and clinical operations.
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3 Ps Of Personal Trial Negotiation: An Expert Shares His SecretsFor each clinical trial, a clinical trial agreement and budget are negotiated between the investigator and the sponsoring company so that the costs of carrying out the trial are reimbursed.
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PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
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Emerging Opportunity in GuatemalaGuatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.
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ePRO in Diabetes StudiesConversion from paper to ePRO for an instrument designed to assess diabetes' impact on quality of life.
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Making a Difference in Cancer Trials AccrualThe integration of pre-screening all patients for eligibility in oncology studies.
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PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
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Early Phase TrialsOptimizing early phase trials key to the success of novel cytotoxics and targeted therapies.
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Hidden Successes of Oncology Trial TerminationsCurrent trends in oncology trial terminations as analyzed by Citeline have revealed that sponsors are learning from the past and making gains in this troubled area of drug development.
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New Technologies Close the Recruitment GapA growing number of providers are adapting 21st century web-based and mobile tools to connect the corners, boost trial participation, and speed trial completion.
