Regulatory agencies require pharmacodynamic data on time-action profiles for
new or biosimilar insulin preparations, including pre-mixed insulins, using
the glucose clamp procedure
In addition there is a general agreement among experts that the glucose
clamp procedure is the best available method for the assessment of insulin
action
Clamp experiments are designed to counteract the blood-glucose-lowering
effect of drugs (e.g. insulin or oral antidiabetic agents) by delivering
variable amounts of glucose, which maintain blood glucose concentrations at
a predetermined target level
Solutions
Handling of both Healthy subject & Patient studies
Protocol Design and insights in clamp protocol
Clamp data analysis and interpretation
Execution of Glucose clamp at Clinical facility (Healthy subjects)
PK sample estimation using ELISA
Our Infrastructure
04 state-of-art beds with stature lifts that have back-up generators
Fire and chemical hazard systems with standard operating procedures (SOPs) and well-maintained equipment
Tertiary care tie up with Omni hospital, 100 bedded multi-specialty hospital for sophisticated and advanced emergency medical care
Well-equipped special care area to handle medical emergencies with provisions such as cardiac monitor, defibrillator, ECG machine, suction machine, oxygen cylinder, cardiac arrest kit, and anaphylaxis kit
In-house ambulance
A well-trained team that is experienced in handling emergencies