Development of the drug market launching strategy
- Evaluation of the drug role in the modern clinical practice
- Establishment of the direction of drug usage in various nosologies
- Analysis of the drug "niche" in the pharmaceutical market
Medical writing
- Preparation of reviews on the results of pre-clinical and clinical trials of a substance
- Elaboration of clinical trial protocols
- Development of the investigator's brochure
- Execution of patient's (volunteer's) information sheets with the informed consent form
- Development of diaries and questionnaires for a patient
- Adaptation of information and advertising materials within clinical trials
- Elaboration of the final report based on the results of a trial
Statistical processing of study results
- Statistical planning of clinical trials
- Determination of the necessary statistic parameters on the step of clinical trail design
- Calculation of the needed number of patients
- Control of completeness and authenticity of clinical trial data
- Checking of arrays of the data collected, correction of mistakes in bases
- Statistical processing and analysis of clinical trail data
- Calculation of statistical parameters, preparation of statistical reports
- Consulting on statistical data processing
Collection and processing of study data
- Elaboration of data management plan
- Development of the template for case report form (CRF)
- Working out of the electronic CRF design and preparation of its user manual
- Organization of electronic CRF testing
- Technical support of projects throughout the clinical trial
- Creation and tracing of data clarification requests
- Control of authenticity and completeness of data at/in all steps
- Final exporting of clinical trial database
Purchasing and shipping of drugs
- Obtaining a permit for drugs import
- Purchasing of reference drugs
- Purchasing of concomitant therapy drugs
- Organization of drugs shipping to clinical centers with transportation conditions registration (temperature loggers) and full adherence to cold chain requirements
- Drugs storage at the specialized warehouse meeting the requirements
Project management
- Selection and evaluation of clinical centers
- Submission of documents to regulatory authorities for obtaining a permit for carrying-out a clinical trial
- Interaction with the local ethics committees with the aim of approval of all documents of a trial
- Preparation of project plans: project management, monitoring, statistical plans, data and risk management plans
- Approval and signing of contracts with clinical centers
- Organization of materials for a clinical trial purchasing
- Cooperation with bio-analytical laboratories
Clinical monitoring
- Monitoring visits: center opening visits, routine and remote visits, center closing visits
- Control of availability of all necessary notifications/approvals from the local ethics committee
- Check of receipt, storage, and issuance of the investigational drug/reference drug
- Inventory accounting for clinical trial materials
- Control of patients enrollment in a trial
- Confirmation of the procedures of obtaining informed consent forms from patients
- Control of proper randomization
- Control of duly storage and maintenance of trial documents
- Monitoring of adverse events registration
- Tracing and timely reporting about SAE/pregnancy and deviations from the protocol
- Control of compliance with effective regulatory requirements and requirements of the protocol
- Check of trial raw documentation (hospital records, etc.)
- Check of data transfer to case report forms
- Control of documents preparation for archiving
- Elaboration of visit reports
Pre-clinical trials
- Selection and evaluation of pre-clinical trial centers
- Concluding contracts with centers, providing the base for a trial
- Analysis of the pre-clinical trial report and drafting a rough plan for the clinical part
Clinical bioequivalence and phase I trial
- Selection and opening of inspected clinical centers
- Training of the trial team based on study documents
- Purchasing and shipping of drugs and materials for a clinical trial
- Enrollment of healthy volunteers meeting the criteria
- Project management (monitoring and management)
- Shipping of biological samples to the analytical laboratory
- Statistical processing of the results collected, elaboration of the final report
Phase II-IV (later) clinical trial
- Selection and opening of centers throughout Russia
- Formation of a qualified study team, training on study documents
- Purchasing and shipping of drugs for a clinical trial, protocol-specific materials and equipment for a trial
- Enrollment of volunteers (patients) meeting the criteria
- Project management (monitoring and management)
- Organization of activities by the analytical laboratory (if necessary)
- Statistical processing of the results obtained, elaboration of the final report
Registration of active pharmaceutical ingredients and medicinal drugs
- Preparation of the set of documents to be submitted to regulatory authorities to receive a permit for clinical trials execution
- Preparation of the set of documents to be submitted to regulatory authorities to receive a marketing authorization for medicinal drugs and active pharmaceutical ingredients
- Consulting on the issues of documents preparation for regulatory authorities
- Maintenance of documents upon submission to regulatory authorities
Post-marketing supervisory programs
- Tracing of possible extension of indications for drug clinical use
- Determination of the target cohort of patients for leaflet extension
- Execution of meta-analyses and systematic review of the data of clinical trials globally
- Analysis of the risk/benefit ratio for a medicinal drug
Pharmacovigilance
- Implementation of pharmacovigilance within the Russian Federation territory
- Preparation of periodic drug safety reports
