Study Protocol Development

The NPhU Clinical and Diagnostics Center offers services for study protocol designing of clinical and pre-clinical studies for CRO, pharmaceutical companies, and plants.

There is hardly a clinical research conducted without a transparent and professionally designed plan. That’s why every clinical investigation should start from a clinical study protocol composition. The main aim of this documentation is to list all the measures that will be taken during the investigation course in the manner prescribed by the regulatory bodies.

Clinical Trial Protocol Contents

According to the guidelines prescribed by ICH-GCP, the research protocol on clinical trials is aimed to objectively describe the rights and obligations of the parties during the experiment, elicit the methodology, objectives, statistical considerations put into the research basis, study design, subject selection and exclusion criteria, publication policies, project, background information, flow charts, etc. All the supporting information making a research sustainable should be gathered and systematized at the clinical trial protocol development stage for an investigation to start.

International Protocol Compliance

The stage of a clinical research documentation processing plays a significant role in the further investigation result acquisition and validation ensuring the research integrity. That’s why it is critically important that this procedure is carried out with competent, certified, and high-quality specialists with the observance of all the norms of both state and international level. NPhU Clinical and Diagnostics Center works in full accordance with international rules for conducting clinical trials and compiling related documentation. Thanks to this, we provide services in a clinical trial protocol design and follow-up clinical studies around the whole world at the same quality level.

Deep Scientific Research Expertise

Highly skilled and intelligent staff of NPhU CDC has a wide experience of study protocol designing practical activities. Their professionalism is based on deep scientific prowess with an emphasis on practical research activities. We offer our clients a systematized and scientifically-grounded clinical research protocols, which are of great value for pharmaceutical organizations and manufacturing enterprises around the world.

Contact Us

Useful link:
The Laboratory of Clinical Diagnostics