Informed consent is one of the core principles of GCP. When asked if the laboratory has a process for ensuring informed consent is in place prior to analyzing samples and if the process also manages withdrawal of consent, significant differences were noted between CRO and pharma companies, as we...
Diabetic foot infections (DFIs) are a significant complication in diabetes mellitus, leading to increased morbidity, hospitalizations, and healthcare burdens. The growing prevalence of antibiotic-resistant pathogens has reduced the efficacy of conventional treatments, highlighting the need for alternative the...
prevalence, susceptibility to artemisinin-based combination therapy (ACT), transmission patterns and the presence of malaria vectors in the Kikuyu area of the Kenyan Central highlands, a non-traditional/low risk malaria transmission zone where there have been anecdotal reports of emerging malaria ...
Verona Pharma plc, a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its financial results for the fourth quarter and full year ended December 31, 2020, and provides a corporate update.
Modulating delirium through stimulation (MoDeSt): study protocol for a randomized, double-blind, sham-controlled trial assessing the effect of postoperative transcranial electrical stimulation on delirium incidence Trial registration {2a and 2b} The trial was registered on 23 February 2024 in the German...
(GCP) Guidelines. For all ROCKET studies, the respective study protocol, any protocol amendments, informed consent form, investigator’s brochure, and other relevant documents are submitted by the principal investigator to their respective IRB/Independent Ethics Committee (IEC) and reviewed and approved...
Over the past decade, there has been a transformation in the portfolio of medicines to combat malaria. New fixed-dose artemisinin combination therapy is available, with four different types having received approval from Stringent Regulatory Authorities o
Over the past decade, there has been a transformation in the portfolio of medicines to combat malaria. New fixed-dose artemisinin combination therapy is available, with four different types having received approval from Stringent Regulatory Authorities o
The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent. Any change or addition to the protocol can only be made in a written protocol amendment that must be approved by the sponsor...
Culminating evidence shows that current care does not optimally meet the needs of persons with parkinsonism, their carers and healthcare professionals. Recently, a new model of care was developed to address the limitations of usual care: Proactive and Integrated Management and Empowerment in Parkinson...