We conduct clinical trials, including the preparation of medical documentation and comprehensive support throughout all stages of the study, culminating in the preparation of the final trial report.
– Study Protocol
– Investigator’s Brochure
– Case Report Form
– Patient Informed Consent Form
– Patient Diary
– Feasibility of clinical sites
– Feasibility ofresearch and diagnostic laboratories
– Assistance with obtaining permission to conduct the study
– Assistance with clinical siteaccreditation (if necessary)
– Assistance with contracting the site
– Assistance with contracting the laboratory
– Assistance with contracting the insurance company
– Obtaining IEC approval
– Importing the investigational drug (if necessary)
– Preparation of the trial master file
– Printing study documents and preparing investigator files
– Preparing training materials and conducting training for the research team
– Conducting the initiation meeting
– Conducting initiation and close-out visits
– Conducting interim monitoring visits
– Preparation of the statistical analysis plan
– Preparation of the statistical report
– Preparation of the final clinical trial report
Clinical trials play a central role in the process of introducing new medicines. They are necessary to ensure the safety and efficacy of medicines that will later be used to treat patients. Conducting a clinical trial is a mandatory step before a new medicine can be registered and marketed.
“PharmAssistence” LLC organizes and conducts clinical laboratory trials for organizations operating in the Eurasian Economic Union and the CIS. We understand that this process is extremely important and responsible, so we carefully prepare for each stage of the process. Our specialists have considerable experience in supporting clinical trials, following the principles of scientific methodology in medicine.
We can help you conduct small clinical trials of a medicine as well as large-scale trials. We can organize turnkey trials. With us, you will save time and money and be able to launch a medical product in the country in a timely manner.
Our team of professionals will develop a study protocol, assist in the preparation of the documentation package, select a clinical trial site, provide study monitoring and auditing, and prepare the final report. By working with us, you will have a reliable partner who will help you successfully implement your project and achieve your goals.
Every year, our professional piggy bank is replenished with many successfully completed projects. Each study is unique, as we develop individual strategies that take into account the specific goals and objectives of our clients. To everyone who cooperates with us, we offer:
Do you want to organize clinical trials of drugs in Russia, the CIS and the EAEU? We invite you to cooperate!
You can contact us using one of the suggested contacts or by requesting a callback.
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