Lead Auditor 

Amyotrophic Lateral Sclerosis (ALS)

Prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 study.

(Series of site audits performed in Italy)

Lead Auditor 

Alzheimer Disease

Multicenter, double-blind, placebo-controlled, randomised, parallel-group, phase 3 study.

(Series of site audits performed in Spain and Slovakia) 

Lead Auditor 

Gastro-Intestinal Stromal Tumor

Prospective, multicenter, randomised, open-label, active-controlled, phase 3 study.

(Series of site audits performed in Netherlands)

Auditor 

Prevention of Fracture in Ambulatory Postmenopausal Women with Severe Osteoporosis

Randomized, double-blind, placebo-controlled, comparative, phase 3, multi-center study.

(Series of site audits performed in Czech Republic, Poland and Romania)

Auditor 

Spasticity in Stroke Study

Randomized, controlled, open-label, parallel-group, multi-center study.

(Series of site audits performed in Germany) 

Auditor 

Cardiac Indications

Prospective, multicenter, open-label, post market study.

(Series of site audits performed in Czech Republic) 

Clinical Research Specialist 

Degenerative Cervical Disc Disease (Medical Device Study)

International, prospective, multicenter, non-interventional post market release study intended to collect data prior and after Cervical Disc replacement.

(Responsible for study setup and management of all study related activities in Czech Republic, Slovakia, Hungary and Serbia) 

Senior CRA

Intervertebral Disc Replacement Prosthesis Clinical Evidence (Medical Device Study)

Retrospective, multi-center, non-interventional, post-marketing study.

(Responsible for study setup and management of all study related activities in Czech Republic, Slovakia and Venezuela) 

Lead CRA 

Huntington's disease

Observational, prospective, multi-national, multi-centre study of HD affected at all stages and their families including premanifest gene carriers, confirmed non-HD mutation carriers and at risk individuals, and a volunteer control group.

(Responsible for monitoring activities supervision in France, Belgium, Italy, Spain, Netherlands, Portugal, Denmark and Germany)

Lead CRA 

Multiple Sclerosis

Phase 3, randomised, double-blind, placebo controlled, parallel groups, multicentr study.

(Responsible for monitoring activities supervision in Czech Republic, Slovakia and Poland)

Senior CRA 

Non-Radiographic Axial Spondyloarthritis

Phase 3, multicenter, randomized, double-blind study comparing the efficacy and safety of continuing versus withdrawing study drug therapy in maintaining remission.

(Responsible for study setup and monitoring of sites in Slovakia)

Senior CRA 

Aneurysmal Subarachnoid Hemorrhage

Phase 3, multicenter, randomized, double-blind, placebo controlled, parallel group, efficacy and safety study.

(Responsible for study setup and monitoring of sites in Czech Republic)

Senior CRA 

Dermatomyositis

Phase 2, randomized, double-blind, placebo controlled trial.

(Responsible for study setup and monitoring of site in Czech Republic)

Senior CRA 

Clinical evaluation of total artificial heart for patients with advanced heart failure (Medical Device Study)

Prospective, international, multi-center, interventional, single-arm study.

(Responsible for study setup of site in Czech Republic)

Senior CRA 

Functional Mitral Valve Regurgitation (Medical Device Study)

Prospective, multi-center, single-arm trial.

(Responsible for study setup and monitoring of site in Czech Republic)

Senior CRA 

Measurement of Low-energy Stimulation in Patients with Atrial Fibrillation (Medical Device Study)

Non-significant risk, prospective trial.

(Responsible for study closure of sites in Czech Republic)

Senior CRA 

ActiveModerate Crohn's Disease

Prospective, multi-center, single-arm trial.

Phase 3, double-blind, placebo-controlled, parallel-group, multicenter, multiregional trial.

(Responsible for study monitoring of sites in Czech Republic)

Senior CRA 

Study of the Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator for Emergent Revascularization in Acute Ischemic Stroke (Medical Device Study)

Randomized, placebo controlled, double-blind study.

(Responsible for study setup and monitoring of sites in Czech Republic)

Senior CRA 

Study of Recombinant Factor IX Product in Previously Treated Pediatric Subjects with Hemophilia B

Non-randomized, open label design that includes an initial pharmacokinetics evaluation in all participants, followed by six months (50 exposure days) of treatment.

(Responsible for feasibility / selection of investigators, study setup, regulatory matters and monitoring of sites in Czech Republic)

Senior CRA 

Induction treatment of active Hemophagocytic Lymphohistiocytosis

Open label single arm pilot study to investigate the safety and efficacy of intravenous multiple administrations of fully human anti-interferon gamma (anti-IFNγ) monoclonal antibody, as induction therapy in patients with Hemophagocytic Lymphohistiocytosis.

(Responsible for study setup and regulatory matters of site in Czech Republic)

Senior CRA 

Malignant Wounds (Medical Device Study)

Prospective, open, non-controlled clinical investigation to evaluate the adequacy of a new dressing in patients with malignant wounds.

(Responsible for study setup and monitoring of sites in Czech Republic)

Senior CRA 

Venous Leg Ulcers (Medical Device Study)

Multicenter, post-marketing clinical investigation to evaluace the performance and safety of a soft silicone foam dressing in exuding Venous Leg Ulcers.

(Responsible for study setup and monitoring of sites in Czech Republic)

Senior CRA 

Primary Cemented Total Hip Arthroplasty (Medical Device Study)

Prospective, randomised, uncontrolled, single-centre, post-market surveillance study.

(Responsible for study setup and monitoring of site in Slovakia)

Senior CRA 

Degenerative Disc Disease, Facet Joint Disease and/or Pseudo Arthrosis Post Anterior Instrumentation (Medical Device Study)

Multi-center, prospective, single-arm, post market clinical follow up study to assess outcomes in subjects with chronic low back pain.

(Responsible for study setup and monitoring of site in Slovakia)

Senior CRA 

Stress Urinary Incontinence Treatment with Clinical Performance Evaluation (Medical Device Study)

Prospective, multicenter, observational, single arm, post-market release study.

(Responsible for feasibility / selection of investigators and study setup in Czech Republic)

Senior CRA 

Survey of Inhibitors in Plasma-Product Exposed Toddlers

Independent, international, multicentre, prospective, controlled, randomised, open label clinical trial.

(Responsible for study setup and monitoring of sites in Czech Republic and Slovakia)

Senior CRA 

Minimal Access Spinal Technologies Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (Medical Device Study)

Prospective, multicenter, observational, post-market release study.

(Responsible for study setup and monitoring of sites in Czech Republic and Slovakia) 

Senior CRA 

Herniectomy versus Herniectomy with a Spinal Stabilization System for the Treatment of Complex Disc Disease (Medical Device Study) 

Prospective, randomized, controlled, multi-center trial to assess surgical and clinical outcomes.

(Responsible for study setup and monitoring of sites in Czech Republic)

Senior CRA 

Autonomic regulation therapy to enhance myocardial function and reduce progression of heart failure with reduced ejection fraction (Medical Device Study)

Multi-center, open-label, randomized, controlled clinical trial with an adaptive design.

(Responsible for monitoring and closure of sites in Czech Republic)

Senior CRA 

Clinical and radiographic early outcomes of hip arthroplasty with cementless stem (Medical Device Study)

Post-market study.

(Responsible for study setup and monitoring of site in Czech Republic)

Senior CRA 

Outcomes of stem with cup after total hip arthroplasty (Medical Device Study)

Prospective, randomized clinical study.

(Responsible for study setup and monitoring of site in Slovakia)

Senior CRA 

Clinical and radiographic early outcomes of total knee arthroplasty (Medical Device Study)

Prospective, post-marketing study.

(Responsible for study setup and monitoring of site in Slovakia)

Senior CRA 

Treatment of predominantly chronic venous leg ulcers (Medical Device Study)

Multicentre, prospective, randomized, open-label, assessor blinded study.

(Responsible for study setup, monitoring and closure of sites in Czech Republic)

CRA I and II 

Pilot Neck Vertebral Compression Fractures Study (Medical Device Study)

Basic & pre-clinical research, cadaver models.

(Responsible for study setup and monitoring of sites in Slovakia)

CRA I and II 

Multiple Sclerosis

Phase II, multicenter, randomized, parallel-group, partially blinded, placebo controlled study in patients with RRMS.

(Responsible for feasibility / selection of investigators, study setup, regulatory matters and monitoring of sites in Czech Republic)

CRA I and II 

Diabetes Mellitus

Experimental biobank repository study.

(Responsible for feasibility / selection of investigators, study setup, regulatory matters and monitoring of sites in Czech Republic)