Skip to Content

Clinical trial protocol

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: cc899dbd-9804-4281-9112-9bda1e6b838d

Service Description

Description of sequence and structure of particular activities of a clinical trial (CT). Selection of a suitable trial design and identification of alternative clinical trial designs and implementation issues. Service includes: Initial Consultation with CT Coordinator: planning of details of a trial such as endpoints and outcomes, sample size calculations, data management, study protocol, randomization, patient and site recruitment, funding, insurance, etc. CT Protocol: elaborating CT protocol for the Investigator (client company! Including necessary documentation kit for CT running (inform consent, donation agreement, etc.) CT Registration: submitting CT protocol to respective authorization body and in Clinical Trials Information System Key words: Clinical trial design, Clinical protocol, Clinical testing, Investigation, Research

Offerings: Data (FAIRness, preprocessing, standardization, best practices, etc.) Ethics & Regulatory Affairs Quality Management Expert Medical Opinion Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Scientific & Medical Communication Development of conformity evaluation standards, protocols & tools Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
Provider Logo

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 estimated cost for service delivery is EUR240 per person-hour. This includes: Personnel Costs: EUR100 (average salary per hour for skilled professionals involved in clinical trial design). Operational Costs: EUR100 (including tools, software, and facility usage). Overhead Costs: EUR40 (covering administrative support, compliance, and other indirect expenses)

Operational Details

Service Inputs Client product information and intention of investigation
Service Outputs Clinical Trial Protocol, Clinical Trial Reg. No.
Dependencies & Restrictions MDR;Ethics vote;GDPR
Service Standards Clinical Trials Regulation, ICH GCP Guidelines
  • Clinical Trials Regulation
  • ICH GCP Guidelines