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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.)
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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 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