Time and effort have their own value and should be budgeted and billed for just as more tangible costs — tests, patient visits, trial supplies, etc. — are, say budgeting and contracting experts who warn sites about letting these intangibles slip through cracks in their systems.
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The third in our series of insights from the 2023 WCG Clinical Research Trends and Insights report focuses on the outlook for oncology, cell and gene therapy, and central nervous system research.
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Rep. Frank Pallone, Jr. (D-N.J.) is pressing the FDA and NIH on their efforts to ensure ClinicalTrials.gov reporting requirements are followed, referencing recent findings in a letter to the agency chiefs that show significant sponsor compliance issues.
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The deadline for mandatory use of the European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) remains Jan. 31 for EU sponsors and regulators following the agency’s success ironing out core software bugs that threatened to delay its official launch date.
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Oncology drug trials should consider a wide range of dosages and how they impact a wide variety of participants, rather than immediately titrating patients up to the maximum tolerated dose (MTD), the FDA said in a new draft guidance.
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Making false claims to FDA investigators is an actual crime that can net you serious prison time, as one Florida CRC working a pediatric drug trial discovered.
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