Hírek és érdekességek

Site Information

Site Name: Simplex Ltd.
Address: 4481 Nyíregyháza, Fácán u. 2. (A.), Hungary
Site Type: Outpatient clinical research site

E-mail: simplexkft@gmail.com

Phone:+36-70-380-8623

Investigator Experience:

Principal Investigator: Dr. Andrea Nagy, MD
Medical Specialties:

• General Practice
• Occupational Medicine
• Diabetology

Clinical Trial Experience:

• Involved in clinical research since 2012
• Experience as Sub-Investigator and Principal Investigator
• Approximately 150 Phase II, III, and IV clinical trials

Therapeutic Areas:

• Hypercholesterolemia
• Hypertriglyceridemia
• Diabetes Mellitus/ Prediabetes
• Asthma
• COPD
• Osteoarthritis
• Cardiovascular outcome studies
• Hypertension
• Nephropathy
• Obesity
• Atrial fibrillation
• Heart failure

Sub-Investigators / Specialists

• Pulmonology studies: Conducted under the supervision of Pulmonologist

Study Team and Resources

• 2 Study Nurses (collectively involved in ~150 clinical trials)
• 12Clinical Trial Coordinator
• Dedicated staff available for patient visits, follow-up, data entry, and study coordination

Facilities

• Dedicated consultation and examination rooms
• Monitoring room
• Sample processing area
• Secure IMP storage area
• Dedicated archive room for study documentation

Equipment and Sample Handling

• Calibrated ECG
• Spirometer
• Medical refrigerator (2–8°C)
• Refrigerated centrifuge suitable for sample processing
• –70°C freezer for long-term sample storage
• Temperature monitoring and documentation available

Laboratory Capabilities

• On-site sample processing (centrifugation, aliquoting, temporary storage)
• Ability to prepare samples according to protocol requirements
• Experience with central laboratory shipments

IMP Storage and Handling

• Temperature-controlled IMP storage
• Continuous temperature monitoring
• SOPs in place for IMP receipt, storage, accountability, and return/destruction

Patient Population and Recruitment

• Access to general practice, diabetology, and pulmonology patient populations
• Experience in recruiting chronic disease patients
• Established patient databases and routine care populations

Data Management

• Experience with EDC systems (e.g. Medidata Rave, Oracle InForm, Veeva)
• Source documentation maintained according to GCP requirements

Monitoring and Audits

• Experience hosting on-site and remote monitoring visits
• Experience with sponsor and CRO audits
• No major findings identified during audits

Regulatory and Compliance

• Full GCP compliance
• SOPs available for all critical study processes
• Experience with ethics committee and regulatory submissions

Start-Up Capability

• Able to support rapid start-up activities
• Feasibility questionnaires, CVs, training logs, and essential documents available upon request