by CRA School | Jul 22, 2020 | Articles, Cliniacal Trials, Clinical Research, Clinical Research
Endpoint selection: a complex process in Clinical Trials End-users of clinical trials such as clinicians, patients, policymakers, industry representatives, and members of the public generate evidence from randomized clinical trials to guide decision-making in clinical...
by CRA School | Jul 14, 2020 | Articles, Cliniacal Trials, Clinical Research, Clinical Research
Pharmacometric modelling and simulation: a tool in therapeutic decision-making When a medicine is prescribed, a fundamental requirement is to understand very well the dose-response relationship in order to determine how much and how frequently to administer a given...
by CRA School | Jun 25, 2020 | Articles, Cliniacal Trials, Clinical Research, Clinical Research
South Korea’s Rapid Emergency Response to COVID-19 Pandemic and Its effect on the Clinical Trials Regulations The pandemic caused by the spread of SARS-COV-2 (Severe Acute Respiratory Syndrome Coronavirus-2, COVID-19) disturbed the natural order of how...
by CRA School | Jun 8, 2020 | Articles, Cliniacal Trials, Clinical Research, Clinical Research, Clinical Research Coordinator, Dentist, Pharmacist, Veterinarians
REGULATORY AFFAIRS FOR MEDICAL DEVICES A dynamic world full of new challenges Eduardo Mendoza, PhD, CRP Sr Specialist at Zimmer BioMet . Working in the Medical Devices Regulatory Affairs field, I have realized this field is very dynamic and full...
by CRA School | Apr 20, 2020 | Cliniacal Trials, Articles, Clinical Research, Clinical Research
WHO launches the SOLIDARITY study, a global mega trial on the 4 most promising coronavirus treatments The World Health Organization (WHO) has announced a large global trial, SOLIDARITY, to establish the safety and effectiveness of different antiviral drugs in treating...
by CRA School | Apr 10, 2020 | Cliniacal Trials, Articles, Clinical Research, Clinical Research
First-in-humans clinical trials of vaccines: Best practices, regulations and need of regulations MARIA HAIDER, MBBS, CCRP Medical Advisor, CRA School The responsibility for the quality, safety and efficacy of the vaccines lies first and foremost...
by CRA School | Apr 3, 2020 | Clinical Research, Articles, Clinical Research, Clinical Research Coordinator
Do you know GCP ? Test your knowledge onClinical Trials and the Good Clinical Practices If you wish to apply for the Accelerated program, email your answers to this test to support@cra-school.com 1. What is the most important consideration during a...
by CRA School | Mar 27, 2020 | Cliniacal Trials, Clinical Research, Clinical Research
A Summary and Perspective on FDA-guidelines for Clinical Trials Conduct During COVID-19-pandemic In response to the public health emergency posed by COVID-19 virus, the FDA has issued a guideline for conducting clinical research. This guideline, issued for...
