Clinical Trial: Page 3

FDA updates recommendations to modernize design, conduct of clinical trials

By LabPulse.com staff writers

The objective is to make clinical trials more agile without compromising data integrity or protection for study participants, the agency said.

June 7, 2023

Bio-Techne announces interim results on prostate test long-term study

By Maryam Payne

In the prospective, randomized study, researchers are assessing the clinical outcomes of 1,049 men ages 50 and over who have prostate specific antigen (PSA) in the gray zone of uncertain prostate cancer risk.

May 18, 2023

FDA issues draft guidance for implementing decentralized clinical trials

By LabPulse.com staff writers

This draft guidance builds on agency recommendations issued in 2020, which provided clarity for investigators to facilitate trial decentralization in response to the COVID-19 public health emergency.

May 2, 2023

Acutis Diagnostics to use Sophia Genetics technology to develop NGS test

By LabPulse.com staff writers

The assay is being developed to screen patients for clinical trials and help increase data analysis for clinical researchers.

March 28, 2023

Clinical investigators need to be wary of confounding and bias in real-world studies; here is what to look for and how to address it

Clinical investigators need to look out for confounding and bias associated with real-world data in randomized trials and observational studies used to produce real-world evidence (RWE) to assess the safety and efficacy of an intervention.

March 17, 2023

Virtual reality may reduce pain, anxiety in children undergoing blood draws

By Elissa Wolfson

Immersive virtual reality intervention for children undergoing blood draws significantly reduced pain and anxiety when compared with control groups in a study.

February 17, 2023

Labcorp expects to complete Clinical Development business spin-off by mid-year

By LabPulse.com staff writers

The spin-off, named Fortrea, will provide Phases I through IV clinical trial management and commercialization solutions to pharmaceutical and biotechnology organizations globally.

February 9, 2023

AstraZeneca, Capitainer to develop biomarker protocols using at-home patient sampling device

By LabPulse.com staff writers

Capitainer's quantitative self-sampling product automatically separates cells from whole blood using a finger stick that can be done in a patient's home, potentially expanding access to individuals who would participate in clinical trials.

February 1, 2023

Unilabs, Ambry Genetics to provide genetic testing for biopharma firms in Europe, Latin America, Middle East

By LabPulse.com staff writers

The companies aim to address one of the main challenges to the use of genomics in global clinical trials: a lack of standardization in laboratory testing protocols and analysis.

January 26, 2023

After Illumina presentation highlighting Grail potential comes a possible EU fine

By Leo O'Connor

At the J.P. Morgan healthcare event this week, Illumina's CEO said Grail must be operated separately and independently pursuant to measures required by the EU.

January 12, 2023

OpGen to prepare FDA de novo request, completes clinical trial for UTI panel

By LabPulse.com staff writers

The completed trial evaluated the performance of the Unyvero UTI Panel for detecting urinary tract infections using clean-catch or catheter-related urine samples.

December 13, 2022

BillionToOne announces clinical data on NIPT for recessive conditions

By LabPulse.com staff writers

The firm's Unity Screen is designed to assess fetal risk of recessive conditions such as cystic fibrosis, sickle cell disease, the thalassemias, and spinal muscular atrophy.

December 6, 2022

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