Center for Clinical Studies

St. Anne’s University Hospital in Brno will ensure the conduct and execution of your clinical study.

Our Center for Clinical Studies provides:

  • ensuring the organization and coordination of all related activities and processes
  • managing all communication between the hospital and clinical study sponsors (commercial studies)
  • supporting the conduct of academic studies (in collaboration with CZECRIN), and
    serving as a contact point for patients participating in specific studies and for volunteers interested in joining the volunteer database.

At St. Anne’s University Hospital, the following types of clinical studies are conducted:

  • Clinical drug trials
  • Clinical investigations and evaluations of medical devices
  • Academic studies (with CZECRIN support)

As part of administrative support for academic clinical trials, we can assist with:

  • Preparing documents required for regulatory approval, such as:
  • protocol synopsis and full protocol according to SÚKL requirements
  • informed consent forms and patient information materials
  • Concluding agreements with partner centers in the Czech Republic
  • Study monitoring

The entire process is divided into several phases:

1. Study Feasibility

Contact us at feasibility@fnusa.cz, and we will arrange a suitable site for your study. If you contact an investigator directly, please copy feasibility@fnusa.cz in your correspondence.
If you plan a feasibility or qualification visit, let us know — a representative of the Clinical Studies Center will attend.

2. Start-up Phase

To initiate contract negotiations for a clinical study, please send the following documents to trials.icrc@fnusa.cz:

  • draft contract
  • draft budget
  • study protocol and a Czech summary of the protocol
  • patient informed consent form
  • information about any devices loaned for study purposes
  • pharmacy manual
  • laboratory manual
  • any other study manuals (e.g., echocardiography or ECG manual)
  • completed pharmacy questionnaire
  • completed laboratory questionnaire (if FNUSA laboratory services are used)

Clinical Study Contract:

At FNUSA, only a tripartite agreement between the sponsor (or CRO), the principal investigator, and the hospital is permitted. FNUSA prefers contract drafts prepared by the sponsor, which are then reviewed from legal and financial perspectives.
To ensure an efficient study start-up, we recommend sending the contract draft for negotiation simultaneously with the submission of documentation to the regulatory authority.

Before initiating the contract signature process, the following documents must be provided:

Interventional Studies:

  • regulatory authority approval
  • clinical trial insurance certificate
  • extract from the Commercial Register (for both sponsor and CRO)
  • power of attorney (if applicable)
  • contract version for the Contract Register
  • information on the expected regulatory approval date

Non-interventional Studies:

  • notification to the regulatory authority
  • extract from the Commercial Register (for both sponsor and CRO)
  • power of attorney (if applicable)
  • ethics committee approval
  • contract version for the Contract Register

3. Invoicing During the Clinical Study and Travel Reimbursement

a) Send invoicing documents to fakturace.trials@fnusa.cz
b) For information on payments, invoice corrections, received payments, and travel reimbursements, contact fakturace.trials@fnusa.cz or call +420 603 558 099 / +420 731 403 091.

4. Archiving of Clinical Studies

Archiving of study documentation at FNUSA is carried out in accordance with applicable legislation, FNUSA internal guidelines, and sponsor requirements, and is subject to a fee. All study materials are archived within the hospital premises.

Please send study proposals to: feasibility@fnusa.cz
For invoicing matters, contact: fakturace.trials@fnusa.cz

Head of CCS

Lucie Tesárková: lucie.tesarkova@fnusa.cz, +420 731 692 781

Start-up

Hana Machová: hana.machova@fnusa.cz, +420 605 234 855
Lucie Jelínková: lucie.jelinkova@fnusa.cz, +420 735 190 319

Billing Department

Petra Pavlů: petra.pavlu@fnusa.cz, +420 603 558 099
Sabina Sudová: sabina.sudova@fnusa.cz, +420 731 403 091

Academic Projects + Quality Controlling

Klára Kostelanská, PhD.: klara.kostelanska@fnusa.cz, +420 603 565 384

Academic Cooperation

Lenka Součková, PhD.: lenka.souckova@fnusa.cz, +420 734 395 742

Study Coordinators

Pavlína Prosecká: pavlina.prosecka@fnusa.cz, +420 734 643 224
Markéta Lukášová: marketa.lukasova@fnusa.cz, +420 735 190 315
Jana Roche: jana.roche@fnusa.cz, +420 603 560 070
Michaela Pavlacká: michaela.pavlacka@fnusa.cz, +420 603 500 655
Soňa Jakubová Niedermayerová: sona.jakubovaniedermayerova@fnusa.cz, +420 604 755 084
Yana Chuienko: yana.chuienko@fnusa.cz, +420 604 227 117
Tereza Matoušková: tereza.matouskova@fnusa.cz, +420 603 431 823

Clinical Research Nurses

Anna Chvátalová: anna.chvatalova@fnusa.cz, +420 731 069 043
Barbora Poulíková: barbora.poulikova@fnusa.cz, +420 704 675 664