Bioequivalence studies
Bioavailability study with healthy volunteers and patients. Part or Full services.
0 |
years on the market |
0 + |
studies "under one roof" |
0 |
satisfied customers |
Bioequivalence studies
Bioavailability study with healthy volunteers and patients. Part or Full services.
|
Monitoring/quality control
Creation of registers. Patient support programmes. Literature search (systematic, targeted).
|
User testing of Patient leaflet
Documentation development, testing and reporting according to EUA requirements.
|
Registers development and maintenance
Drug and disease registers, safety assessment. Database maintain.
|
Patient' s leaflet development
Patient' s leaflet development for medication.
|
Publications and presentations development
Preparation of articles, reviews, presentations by study results.
|
Phase I-III studies
Evaluation of drug efficacy and safety in different nosologies. Part or Full Services.
|
Literature searching
Literature review, preparing systematic and analytical reviews.
|
Regulatory support
Documents development, obtaining study approval. Assistance in expert's assessment.
|
CoMed Medical Centre
The company's own medical unit.
|
Data management and statistics
eCRF development. Entering data from paper CRFs. Statistics.
|
Communicating with healthcare specialists
Signing of contracts, surveys and expert advice.
|
Preparation of documentation
Preparation of a study documentation (Protocol, BI, ICF, plans, etc.)
|
Adverse events evaluation
Preparation of the RMP and the PSUR. MedDRA coding of AE. Assessment of the causal relationship.
|
Modules for a dossier development
Preparation of sections of the registration dossier in accordance with EAU requirements. Risk management plan.
|
Observational and real-world studies (RWD/RWE)
Study of drug prescription, patient population assessment. Evaluation of effectiveness in a real-world practice. Evaluation of medical resources utilization. Evaluation of discharges in health-care system.
|
Patient support programmes
Educational and information programmes. Diagnostic and laboratory programmes. Increased adherence to medication. Establishment of personal cabinets.
|
Post-registration studies
Phase IV studies, non-interventional studies, registries. Part or Full services.
|