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Information for Sponsors and Contract Research Organizations

Welcome to the official page for Sponsors and Contract Research Organizations. If you are interested in conducting a trial at our center, please reach out to the Principal Investigator (PI), who will oversee the proposal. After discussion with the PI, a feasibility assessment will be conducted, followed by a selection meeting. Should you need supplementary details during this period, further information will be provided by the respective clinical research coordinators at the individual clinics.

 

After the site confirmation, contract negotiations will commence.

 

Contract Negotiation Process

 

To start the contract negotiation process, please complete the  IKEM Clinical Trial Start-up Questionnaire and send it to trials@ikem.cz along with the following documents

 

  • Study protocol in Czech
  • Investigator brochure 
  • Patient informed consent form
  • Pharmacy manual
  • Laboratory manual
  • Clinical manual (for medical devices)
  • Proposed budget: The budget must be submitted in the same currency as the payments for the clinical evaluation will be processed.
  • Draft contract
  • Draft Loan Agreement: If a clinical trial includes the loan of any equipment, a separate loan agreement must be executed. 
  • Regulatory and Ethical Approvals: If available at this stage.
  • If the clinical trial includes an Investigational Medicinal Product (IMP), please complete the online  IKEM Pharmacy Clinical Trial Entry Form  and contact pharmacist Markata Olsovska, MSc. via email at  marketa.olsovska@ikem.cz  to negotiate the pharmacy budget.

  

Required Documents for Contract Signing

 

Before signing the contract, you will need to submit the following documents: 

  • For drug trial: approval from SÚKL via CTIS
  • For device trial: approval from SÚKL and EC 
  • Proof of a valid clinical insurance policy
  • Commercial Register extract for both the Sponsor and the Contract Research Organization (CRO)
  • Power of Attorney (if applicable)
  • Final version of the contract for publication in the Register of Contracts 

 

For information regarding the rules for electronic signatures at IKEM, please see the following link: e-signature

 

Fees and costs 

 

Start-up fee – 40,000 CZK

Observational study start-up fee - 15,000 CZK

Archiving fee – 45,000 CZK

Pharmacy start-up fee – 15,000 CZK 

 * Amounts are stated without VAT

Additional fees are assessed based on the specific requirements of each trial to ensure the most favorable conditions for the successful implementation of your clinical trial. 

 

We accept payments in CZK, EUR, and USD. 

 

For remittance, please select one of the accounts provided below.

 

Currency: CZK       

IBAN: CZ6707100000000042334041    

SWIFT: CNBACZPP           

Account Number: 42334041/0710        

Bank details: Czech National Bank, Na Prikope 28, 115 03 Prague 1, Czech Republic

 

Currency: EUR

IBAN: CZ4007100345340042334041

SWIFT: CNBACZPP           

Account Number: 34534-42334041/0710        

Bank details: Czech National Bank, Na Prikope 28, 115 03 Prague 1, Czech Republic

 

 

Currency: USD

IBAN: CZ2907100348330042334041    

SWIFT: CNBACZPP           

Account Number: 34833-42334041/0710

Bank details: Czech National Bank, Na Prikope 28, 115 03 Prague 1, Czech Republic

  


Our laboratories are certified in the field of laboratory and diagnostic methods in healthcare, approved by the Ministry of Health of the Czech Republic (MZČR). The relevant certificates can be downloaded below.

 

For laboratory reference ranges, please see the following link: IKEM Laboratory 

 

 

Downloadable Documents

 

  

Contact Information

 

Institute for Clinical and Experimental Medicine

Videnska 1958/9, 140 21 Prague 4

CRN: 00023001, VAT ID: CZ00023001

 

Commercial Clinical Trials Coordinator

Lucie Vacirova

Tel: +420 23 605 4205

Email: trials@ikem.cz

 

Clinical Research Coordinator

Tereza Metelcova, Ph.D.

Tel: +420 23 605 2125 or +420 702 297 007

Email: tereza.metelcova@ikem.cz

 

IKEM Pharmacy - Contact person

Marketa Olsovska, MSc. 

Email: marketa.olsovska@ikem.cz     

 

 

CTIS information:

ORG-100013075

Institute For Clinical And Experimental Medicine.

Videnska 1958/9, Prague, Czechia

 

We look forward to our collaboration. 

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