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Home » Newsletters » CenterWatch Weekly

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January 23, 2023

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  • CenterWatch Weekly, Jan. 23, 2023
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Time is Money and So Is Effort, Budgeting Experts Say

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. Read More
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WCG Clinical Research Trends and Insights for 2023, Part Three

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. Read More

Industry Briefs

Rep. Pallone Grills FDA, NIH on Enforcement of ClinicalTrials.gov Reporting

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. Read More

‘Bug’ Fixes Put EU’s Clinical Trials Website Back on Track for Jan. 31 Deadline

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. Read More

Draft Guidance: Re-examined Oncology Protocols Say Maximum Tolerated Dose is Not for Everyone

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participants, rather than immediately titrating patients up to the maximum tolerated dose (MTD), the FDA said in a new draft guidance. Read More

Florida CRC Gets Three Years in Prison for Lying to FDA Investigator

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. Read More

Drug & Device Pipeline News

Twenty drugs and devices were approved or entered a new trial phase last week. Read More

Research Center Profiles

Research Center Profiles are free to use and provide comprehensive listings of hundreds of institutional and independent sites. Read More

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