tag clinical-trial-automation 
Rethinking Clinical Trials
JANUARY 26, 2023
EVOLVE-MI is a pragmatic, effectiveness outcome trial of Evolocumab dosed within 10 days of a myocardial infarction (MI). Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. EVOLVE-MI is enrolling 4,000 patients in 3 countries.
Rethinking Clinical Trials
DECEMBER 12, 2023
It has been studied in prior contexts in a PCORI trial and a pilot inpatient trial where the intervention increased goals of care discussions from 8% to 21%. Jumpstart is a pragmatic randomized trial of Jumpstart compared to usual care. In some previous trials we have randomized at the clinician level.
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Drug Discovery World
JANUARY 30, 2024
Lentivirus strategies are one of the most widely used tools in biomedical research and clinical testing, says Stella Vnook, CEO, Likarda. “Dr Automating and scaling up manufacturing is crucial for cost reduction. Streamlining trial designs and regulatory pathways can help.
Rethinking Clinical Trials
APRIL 13, 2023
The PRESCRIBE trial revealed the value of active choice as well as peer decision-making to prompt decision-making. Implementing the nudge tool within the Penn Medicine revealed several positive impacts, including referral rates increasing significantly via the implementation of a default pathway.
Camargo
AUGUST 22, 2021
When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance. 3.5.1: Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication.
pharmaphorum
OCTOBER 4, 2022
During the first stage of the initiative, more than 2,000 research papers were published, 49 clinical trials were carried out, and more than 30 patents were filed through the support of the US National Cancer Institute (NCI). These datasets are critical as a means to identify how molecular information affects clinical outcomes.”
Drug Discovery World
OCTOBER 21, 2022
The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. When planning a new flow cytometry experiment, the term compensation may be intimidating to those attempting to run their first trial. Biotechniques. 53(1): 57–60.
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