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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

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

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