Clinical Trial Services in USA, India, Europe, & Australia

ProRelix Research is a growth-oriented CRO that 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.

We know the particulars of conducting phase 1, 2, 3, and 4 clinical trial services across the world, so we can make the complex less complicated, mainly for small pharmaceutical, medical device, herbal, nutraceutical, and biopharmaceutical companies that may be new to clinical trials. We have knowledgeable and experienced clinical trial professionals in the USA, India, and in multiple other countries across Europe, Australia, Africa which makes us uniquely positioned to help sponsors plan multi-country regulatory requirements.

Having team-provided clinical trial services for decades, we have determined strategies and processes to increase the speed of conduct and accessibility to new clinical trial sites. Our network with many investigational clinical trial sites, clinical research centers, patient groups, and medical consultants means we bring strong resources to bear in support of your clinical research projects.

Phase 1 Clinical Trial

Conducting phase 1 clinical trials is setting the best dose of a new drug with the fewest side effects on a small group of 15 to 20 trial subjects to check the safety of that drug. This dose-escalation study continues until the maximum dose has been attained as per the protocol requirement. If the 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

The aim to conduct a phase 2 clinical trial is to check the safety and efficacy of the drug with a particular disease and condition and monitoring common short-term side effects and risks 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 the trial subject.

Phase 3 Clinical Trial

The main purpose of conducting a phase 3 clinical trial is to obtain the safety and efficacy of the drug from phase 2 on a large group of people and compare it to commonly used treatment or standard drug or placebo. We are performing all the trials under well-qualified and experienced investigators. We conduct the trials using different study designs like a 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 marketing approval.

Phase 4 Clinical Trial

Phase 4 clinical trials are conducted after the affirmative approval from US FDA, CDSCO, MHRA, EMA, and TGA for marketing purpose. The goal to perform this post-marketing surveillance trial is to 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 of excellent quality with the given timeline.

(You can check our other range of services by clicking on respective pages)

About Us

ProRelix Research is the best clinical research organization (CRO) with global service capability supporting Phase 1, 2, 3, & 4 clinical trials for Pharma, Biotech, Biopharma, Medical device, Nutraceutical & Herbal companies in US, India, Australia, & Europe.

Subscribe Blogs & Newsletter
Loading
Inquire Now
close slider





      Register Now

      All the fields are mandatory