Non-interventional studies and observational programs
The today's drug regulation systems of developed countries strive for continuous post-marketing evaluation of drug efficacy and safety with elaboration of various risk management programs. Such programs combine post-marketing drug safety and efficacy profile studies (by observational, retrospective studies, maintaining registers, active monitoring) and the measures aimed at prevention of drug therapy (risk mitigation tools).
Our Company develops and carries out post-marketing trial programs by implementing the ideas and requests of the manufacturers and controlling the drug efficacy and safety profile upon its usage in real clinical practice.
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 the plan on data management
- Development of the template for the case report form (CRF)
- Working out of the design of an electronic CRF and preparation of its user manual
- Organization of testing of electronic CRFs
- Technical support of projects throughout the clinical trial
- Creation and tracing of data clarification requests
- Control of authenticity and completeness of data on all steps
- Final exporting of the 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 purchasing of materials for a clinical trial
- 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 raw documentation of a trial (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
