ProRelix Research is a growth oriented CRO which provides drug development or clinical trial services from phase 1, phase 2, phase 3 and phase 4 with quality assurance and transparency. We execute services as per our standard SOPs in compliance with ICH-GCP principles, ethics and well being of trial subjects.
Phase 1 Clinical Trial – Conducting phase 1 clinical trials are setting a best dose of a new drug with fewest side effects on small group of 15 to 20 trial subjects to check safety of that drug. This dose escalation study continues until the maximum dose has been attained as per the protocol requirement. If drug is found to be safe, then it can be tested in phase 2. It includes single as well as multiple dose administration. Here we are analyzing pharmacokinetic and pharmacodynamic parameters in strict regulations. This trial can be performed in single as well as multicenter also.
Phase 2 Clinical Trial – Aim to conduct phase 2 clinical trial is to check safety and efficacy of the drug with particular disease and condition and monitoring common short term side effects and risk associated with the drug .Here we are performing accurate monitoring in compliance with ICH-GCP principles, SOPs and the applicable regulatory requirements to ensure the right, safety and well being of trial subject.
Phase 3 Clinical Trial – Main purpose of conducting phase 3 clinical trial is to obtain safety and efficacy of the drug from phase 2 on large group of people and compare it to commonly used treatment or standard drug or placebo. We are performing all the trials under the well qualified and experienced investigators. We conduct the trials using different study designs like randomized trial, open label/double blinded, parallel, crossover trial, etc. which depend on the protocol requirement. We are successfully conducting such trials and meeting the requirements of the regulatory body for the marketing approval.
Phase 4 Clinical Trial – Phase 4 clinical trials are conducted after the affirmative approval from DCGI for the marketing purpose. Goal to perform this post marketing surveillance trial is obtain additional information about the risk and benefits resulting from the long term usage of the drug on thousands of participants. Other purposes are also exploring new uses of the drug, drug-drug interactions, etc.
When you are outsourcing to ProRelix Research for conducting clinical trials, you are assured about all your services are in excellent quality with given timeline.
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