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Clinical Study Center

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 73a9bd9a-45cc-4ab5-b047-35efecb7c1e8

Service Description

The Clinical Study Center offers comprehensive support for the design, implementation, and management of clinical trials. This service focuses on ensuring the integrity, quality, and compliance of clinical studies across various medical fields. The center provides expert guidance on protocol development, regulatory submissions, site management, and data collection, ensuring that all trials meet regulatory standards and are conducted ethically. With a dedicated team of experienced professionals, the center facilitates patient recruitment and retention, monitors trial progress, and ensures accurate data reporting.

Offerings: Research & Development Ethics & Regulatory Affairs Expert Medical Opinion Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Scientific & Medical Communication Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
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Provider & Contact

Provider Country Slovakia
Published Email tef@unm.sk
Billing: per hour/person
Full Price €240 EUR
Reduced Price €180 EUR
Pricing Detail

The average cost for service delivery, including all expenses (personnel, operational costs, equipment, and overhead), is estimated at EUR220 per person-hour. This includes: Personnel Costs: EUR80 (average salary per hour for skilled personnel with expertise in clinical study management). Equipment and Operational Costs: EUR100 (includes data management systems, clinical trial supplies, and facility usage). Overhead Costs: EUR40 (administrative support, compliance costs, insurance, and other indirect expenses).

Operational Details

Service Inputs Study protocol, regulatory requirements, and relevant clinical documentation (e.g., informed consent forms, investigator brochures)
Service Outputs Comprehensive clinical study reports, including data analysis, patient demographics, and trial outcomes
Dependencies & Restrictions MDR;GDPR;Ethics vote;Facility costs
Service Standards ICH GCP, MDR 2017/745 (and MDR 536/2014 for clinical drug trials)
  • ICH GCP
  • MDR 2017/745