Request for Proposal

Currency of the proposal:
Other available information and other requests:

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Type of product:
Therapeutic area:	allergies/respiratoryanesthesiologycardiovascularCNSdermatologyendocrinologygastroenterologyhaematologyimmunologyinfectious diseasesoncologyophthalmologypediatricsrare diseasesreproductive healthrheumatologyurologywomen's health/obstetricsother (please indicate below)
Indication:
Phase:	IIIIIIIVdeviceother
Number of sites:
Location of sites:	USAEUEAEU (Russia, Belarus, Kazakhstan)UkraineIndiaother (please indicate below)
Number of enrolled patients:
Number of completed patients:
Number of patient visits (including screening):
Enrollment period (months):
Treatment and Follow-up period (months):
Monitoring frequency (per site):
Required SDV (%):

Feasibility
Regulatory submission
Organization of the Investigator meeting
Patient insurance
Investigator agreements and payments
Medical writing	Protocol designInvestigator brochureICF, Patient informationFinal CSR
Data management, biostatistics	SDTMCDISC complianceCRF development
Medical monitoring
PVG and safety	Safety reviews of SAEsConstruct CIOMS formsSubmit CIOMS formsHold and mantain the SAE databaseReconciliationDSMB
Vendor management	Central labSpeciality lab (PK/Imaging)Other (please specify below)
Clinical monitoring	Qualification visitsSite initiation visitsSite monitoring visitsClose-out visits
Drug supply management	IRT/IWRSCourier shipmentsWarehouse/StoragePackaging and labelingDestruction Package size: Cargo volume: Number of shipments to depot: Number of shipments to sites: Drug storage/shipment conditions: Other available information about IP:
Project management
Audits
Local prchase/distribution of consumables, equipment
Laboratory kits logistics
Biosamples logistics
Consulting
EU representation
GDPR compliance
Other

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