Clinical trials
Perform every phase of your trials immaculately and gather complete data about your products.
Our service includes:
- Maintaining all kind of agreements with investigators, site staff, hospital managers, vendors and facilities (where applicable) and sponsors (CDA, CTA etc.)
Regulatory
- Maintaining all regulatory activities according to local/EU laws from the Drug Board committee (Drug Committee), Central Ethics Committee and Ministry of Health. This service includes:
- Submission of documentation packages to get initial approvals of Drug Boards and CEC and MoH
- Notifications to all regulatory authorities during the study (from start up till close out)
- Submission of documentation packages to all regulatory authorities to get any kind of additional approval during the study (as applicable, addendum to protocol, investigator broschures, new versions of ICFs..)
- Maintaining PV activities in clinical trials – this service includes submissions and notifications to regulatory authorities and sponsor of CIOMS reports (when applicable), DSUR, 6-month line listing, PSUR, etc. plus follow up on every CIOMS report with investigators and sites and notifying Drug Board (where applicable)
- Feasibility testing of all sites – this service includes feasibility action in two phases:
- On-line like primary phase (via questionnaires etc.)
- In-person visit after selection, which includes all sites in Croatia and the region, where applicable
- Organization of all site visits – this service includes sites set up for all kinds of visits from selection visits, initiation visits, routine monitoring visits (scheduled/unscheduled), close-out visits and end-of-trial follow-up visits. Our team handles all pre-visit and postvisit actions (education of personnel etc.)
- Support during screening, enrolling or discontinuing patients from the study
- Closing sites, equipment returns and archiving complete documentation until transfer to the sponsor
- Maintaining all shipments for sites – this service includes ordering all medicine kits, medical devices and other materials for sites which are necessary for the trial (notebooks, refrigerators, data forms, centrifuge for laboratory etc.)
- Translation of clinical trial documentation – this service includes in-house translation of all clinical trial documentation with necessary QC (confirmation of translation) and certification of proofreading. In case of urgency/overload we can ensure our vendor partner to comply with all deadlines
- Preparation of sites and personnel for inspections (of all regulatory authorities) and audits (internal or sponsors’ audit)
Contact us
Headquarters
Lašćinska cesta 40
HR-10000 Zagreb
Croatia
Office
Planinska ulica 13/2
HR-10000 Zagreb
Croatia
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
info@martifarm.com
Pharmacovigilance
farmakovigilancija@martifarm.com
Tel: +385 1 5588 297
Legal info
Full company name
Short company name
Headquarters
Office
Legal form
Court register
Registration number
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
080751121
OIB
Share capital
Authorized representative
29969122438
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
Bank account
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)
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