Medical Consulting
Comprehensive Support for Clinical Trials and Documentation Development: From Consulting to Registration
OUR SERVICES:
- Consulting support
- Training of research center personnel
- Ongoing communication with regulatory authorities and local ethics committees
- Selection and evaluation of research centers
- Organization of Investigator Meetings and training during center initiation
- Preparation of study budgets
- Negotiations and assistance in contract execution with research centers and investigators
- Preparation and conduct of joint monitoring visits
- Preparation of reports based on monitoring visit results
- Coordination of reports on serious adverse events
Development of Documentation Package for Clinical Trials:
- Study protocol design
- Individual registration forms
- Investigator brochure
- Patient information sheet
- Informed consent form
Development of Regulatory Documentation (Specifications, IMP, textual content of packaging mock-ups, package insert, and quality control documentation)
Preparation of literature references, reviews, and writing registration modules 2.2-2.7 in accordance with EAEU regulations.
OUR SERVICES:
- Consulting support
- Training of research center personnel
- Ongoing communication with regulatory authorities and local ethics committees
- Selection and evaluation of research centers
- Organization of Investigator Meetings and training during center initiation
- Preparation of study budgets
- Negotiations and assistance in contract execution with research centers and investigators
- Preparation and conduct of joint monitoring visits
- Preparation of reports based on monitoring visit results
- Coordination of reports on serious adverse events
Development of Documentation Package for Clinical Trials:
- Study protocol design
- Individual registration forms
- Investigator brochure
- Patient information sheet
- Informed consent form
Development of Regulatory Documentation (Specifications, IMP, textual content of packaging mock-ups, package insert, and quality control documentation)
Preparation of literature references, reviews, and writing registration modules 2.2-2.7 in accordance with EAEU regulations.
Moscow, 117105, Varshavskoye Highway, Building 1, Block 6.
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