Regulatory
DRUG TRIALS SNAPSHOTS at a GLANCE: 2022
Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who par…
Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who par…
Nepal's public health care facilities are facing a significant challenge in ensuring the quality of ess…
When seeking product registration with the Department of Drug Administration (DDA), pharmaceutical companies …
The Department of Drug Administration (DDA) in Nepal is responsible for regulating the import, manufacture, a…
An electronic trial master file (eTMF) is a digital repository of documents and other materials related to a…
A case report form (CRF) is a document used in clinical research to record data collected during a study. It…
Documents play a critical role in clinical research, as they help to ensure that the study is conducted in …
Standard operating procedures (SOPs) are detailed, written instructions that outline the steps required to p…
Quality assurance (QA) and quality control (QC) are important components of clinical research, and are desig…
Site initiation and activation are important steps in the process of conducting a clinical trial. Site i…
A Data Safety Monitoring Board (DSMB) is a group of independent experts who review the safety and efficacy d…
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH…
Clinical database development is a critical aspect of clinical research, as it involves the design and imple…
Biostatistics is the branch of statistics that is applied to the field of health and medicine. In clinical r…
Clinical data management is the process of collecting, storing, and analyzing data from clinical trials to s…
Site monitoring and management is a critical aspect of clinical trial management, as it involves the oversigh…
Ethics committees typically review clinical research studies at various stages of development, including th…
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH…
Clinical research is an essential part of the drug development process, as it involves testing new drugs in …
The drug development process is a complex and lengthy process that involves several steps from the initial d…