Authors
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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.
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Emerging Opportunity in GuatemalaGuatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.
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Blockchain Use in ResearchThe core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data.
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Are Phase III Clinical Trials Really Consistently Behind Schedule?With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.
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Panel Discussion: Merck R&D’s Digitally-Enabled Clinical Trial Team***Tuesday, January 12, 2021 at 11am EST | 8am PST | 4pm GMT | 5pm CET***Merck’s Digitally-Enabled Clinical Trial Initiative Members or “Smart Team” will discuss their experiences introducing digital technologies into the clinical trial paradigm and within their function. *** On demand available after final airing until Jan. 12, 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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Emerging Opportunity in GuatemalaGuatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.
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Developing Quality BiosimilarsBiosimilars are a steadily growing new field of biopharmaceutical development and clinical research.
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Using 505(b)(2) to Solve Shortfall from Generic CliffUnderstanding the benefits of this application route in helping companies withstand the hit of patent expiries.
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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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The Virtual Organization: Is It the Future Industry Landscape?Outsourcing and data-sharing technologies are creating virtual pharmaceutical companies. Soon, you may be only as good as your network.
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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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Risk Assessment and MitigationA quantitative approach to enhancing risk assessment and mitigation in drug development.
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Understanding FDA’s Perspective on Precision DosingContinued embrace of precision dosing will reduce costs and optimize clinical outcomes.
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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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What We Can Anticipate from TransCelerateThe somewhat-awkwardly named TransCelerate BioPharma immediately got an enthusiastic reception from industry watchers and participants, mainly due to the perception that it was well poised to attack some of the systemic causes of delays and cost overruns that plague clinical trials today.
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ePRO Industry GrowthA countdown of the top 10 developments that have most influenced the ePRO industry over the past decade.
