During the planning and preparation phase of a clinical trial, study organizers require the development of a comprehensive set of documents for the registration of therapeutic equivalence, bioequivalence, or early-phase clinical studies, as well as for regulatory and post-marketing studies.

Clinical Trial Documentation ServicesCerta Clinic LLC has extensive experience in the pharmaceutical industry and clinical research, providing services for the development of documentation for Phase I–IV clinical trials, including bioequivalence studies. Our specialists prepare the following documents:

• Clinical Study Protocol Synopsis with sample size calculation
• Clinical Study Protocol
• Investigator’s Brochure
• Patient Information Sheet with Informed Consent Form
• Articles and literature reviews on the specific investigational medicinal product

At our Clinical Center, the documentation is developed by physicians with scientific expertise in various therapeutic areas and experience in clinical documentation. Physicians work closely with biostatistics specialists to ensure scientific accuracy and statistical rigor.

• Information Required for Documentation Development:Data from previously conducted preclinical and clinical studies of the investigational drug, including in-house preclinical studies (for reproduced drugs)
• Draft of the Investigator’s Brochure or Summary of Product Characteristics

The Protocol is the main document of a clinical trial, detailing the study objectives, methodology, study population, procedures, treatment methods, and statistical analysis plan. Before drafting the Protocol, optimal endpoints are selected based on literature review and prior studies, the sample size is calculated considering patient dropout rates, and the study design, population, statistical methods, inclusion/exclusion criteria, and procedure schedule are defined.

From this process, a Clinical Study Protocol Synopsis is created. Once approved by the sponsor, it serves as the foundation for the full Protocol.

The Investigator’s Brochure is a key document providing a summary of preclinical and clinical data on the investigational drug for medical use. It follows a structured format including: general information, physical, chemical, and pharmaceutical properties, preclinical study data, clinical study data, discussion, and the product’s medical instructions.
The purpose of the Investigator’s Brochure is to provide investigators with all available information on the investigational drug, including safety data. The brochure is updated periodically to reflect new data as the investigational product progresses. Depending on the completeness of the provided preclinical or clinical materials, additional literature searches may be performed.
If necessary, all documentation, including materials provided by the client or sourced from literature, can be professionally translated.

The Patient Information Sheet with Informed Consent Form is a single document consisting of two inseparable parts. By signing it, the participant provides written consent to participate in the clinical trial and agrees to the conditions of the Protocol. This document is prepared based on the Clinical Study Protocol and presents the study information in a clear and understandable format.

• The Individual Registration Card (IRC) is a paper or electronic form used to collect data obtained during the clinical portion of the study for each participant and is submitted to the Sponsor. Development of the IRC begins after the Protocol has been finalized.