Human studies letöltés

HUMAN STUDIES

IN OUR INSTITUTE

human studies

COFOPEX LTD.
Bimbó út 92.
1022 BUDAPEST
HUNGARY

E-Mail: barai@mail.datanet.hu
mobile: +36 20 9357 867

About Us

Network of professionalism - Expertise on Time

Our institute was founded in 1997 as a privately owned Hungarian Clinical Research Company for providing services to the healthcare and allied pharmaceutical biotechnological industries. These services include Phase I-IV Clinical Trials and their managements.

térkép

The institute is complete with a Phase I Unit meeting the necessary international requirements, a Biochemical and Molecular Biology Laboratory, an Outpatient Clinic offering treatment for patients with Ostoporosis, Diabetes or Cardiovascular diseases and finally an SMO (Site Management Organization) system: a network of many GPs and specialists working nearby.
The institute accredited Phase I Unit also participates in the education of the Semmelweis University (Budapest) for vocational and practical (manual) training in Clinical Pharmacology.

Headquarters of the institute are located in Balatonfüred, one of the most beautiful recreational cities of Central Europe. As a medium sized, flexible and dynamic organisation can offer competitive price,- and time setting for clinical trials.

Personnel

The dedicated team has a group of highly skilled professionals with an understanding of customer needs and all specific expertise in project demands.

Our team consists of 6 MDs with at least two specializations from the medical fields of Clinical Pharmacology, Diabetes, Cardiology and Endochrinology and their work is strongly supported by highly skilled study nurses, coordinators and administrative help. The lab is run by chemical engineers and skilled lab technicians.

Clinical Pharmacology Services

Phase I.
Our laboratory is accredited for phase I., II. studies by National Pharmaceutical Institute.
Our laboratory provides comprehensive research and accelerated development services for pharmaceutical products according to ICH-GCP and FDA standards.

Phase I Trials

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The institute has an independent Phase 1 Unit, with a total capacity of 18 beds. Short and long term hospitalization is possible.

Rooms, bathrooms and toilets are equipped with an Internal alarm system.

The nearby Intensive Care Unit, the recreation room, the separate drug supply unit and the Archive room all serve the Site.

The institute performs the following types of clinical trials: first-into-man; interaction; pharmacokinetics for patients with liver and kidney diseases; bioequivalence and bioavailability

The attached reference list demonstrates the international acceptance of our institute Phase I activities.

Phase II-III Trials

The institute can collect patients from the following therapeutic areas:

Cardiovascular Diseases, Diabetes, Osteoporosis, Musculoskeletal diseases, Hyperlipidemia, Obesity; Hypertension, Asthma, COPD, chronic and acute bronchitis and tumors.

The attached reference list demonstrates the international acceptance of institut’s Phase II-III activities.

Site Management Organisation (SMO)

The institute has established an SMO system: a network of investigators. The company has special collaboration with County Hospitals, Outpatient Clinics, Dyalisis centres and General Practitioners.

Each trial is conducted by institute’s dedicated staff, including Principal Investigators, nurses and coordinators. SMO MDs either take part actively in the trial or collect patients - according to the wish of the Sponsor.

The institute keeps in touch with the investigators. The company offers regular general GCP as well as trial-specific trainings for MDs. Whether SMO MDs take part in the trial as investigators or as a doctor referring patients - depends on the structure of the actual trial and the Sponsor’s decision.

If they are investigators, than the institute ensures the administrative coordination of a trial (permissions, contracts), quality control, collection and handling of laboratory samples, drug supply and completing CRF-s. This cooperation enables the institute to enrol a lot of patients into studies and also to have access to special patient populations.

Expertise

We work with specialists from the following fields of Medicine:

  • Clinical Pharmacology
  • Endocrinology
  • Internal Medicine
  • Paediatrics
  • Diabetes
  • Osteoporosis
  • Cardiovascular Diseases
  • Allergy
  • Pulmonology
  • Rheumatology
  • Gastroenterology
  • Radiology
  • Ophthalmology
  • Neurology
  • Gene technology, Clinical Genetics and Parmaco-Genetics
Services
Quality Execution of Clinical Studies

Phase I-II and III studies with the involvement of healthy young and elderly volunteers, patients with kidney, hepatic diseases, hypertension, dislipidemy, respiratory, cardiovascular , allergic-, and rheumatoid arthritis diseases.

Project Management

Experienced project management guarantees efficient operational execution on time for:

  • Compilation of Proposals
  • Planning and Preparation of Trials
  • Submission to the Local Ethics Committee
  • Regulatory Services
  • Clinical Document Managing
  • Drug Handling (storing, distribution and accounting)

Volunteer/ Patient Pool

The unique cooperation with the Hospitals and the regional outpatient facilities in different medical fields provides special patient/subject populations, making it possible to conduct a broad range of successful clinical pharmacological studies.

Healthy volunteers

Young male, female volunteers
Elderly male, female volunteers

Patient Population

Patients with Cardiovascular-, Diabetic-, Osteoporotic, Rheumatoid, Hyperlipidemic or Asthmatic diseases, obesity; chronic or acute bronchitis.

Special Methods

Establishing new methods is a time consuming task at study preparation phase.

The institute is experienced in this respect, the general procedures (training, set up, validation, SOP) are laid down to guarantee successful management and quality control of new methods.

  • Psychometric Testing (wide range of paper and computer-aided assessments)
  • Inzulin resistence examinations („euglycaemias clamp” technique)
  • HOLTER
  • ABPM
  • Respiratory function examinations
  • Plasmaferezis, Stem cell isolation
  • Genotyping
  • Gene polimorphism and gene expression
  • Pupillomety
  • Special Cardiovascular Testing examinations (ECHO, Ergometry, Electrophysiology, Cathetherisation)
  • Cryo-preservation and storing
  • Endoscopy in backgroung institution
  • HOLTER monitoring

LABORATORY

labor
Clinical Biochemistry
  • Clinical Chemistry
  • Blood and coagulation tests
  • Urine analysis
  • Virus- and Drug-tests
  • Pregnancy tests from urine and blood
  • Special tests and markers (in bone-, metabolic endocrine and cardiovascular diseases)

Tests are performed with high capacity laboratory automated equipment. Permanent participation in the independent quality control system.

The laboratory has huge storing capacity either on +4 °C, -20 °C,-80 °C or in liquid nitrogen.

Molecular Genetics:

Test types:

  • Cell, DNA, RNA isolation and storing
  • Cryo preservation and storing
  • Genotyping (Pharmaco - and Toxicogenetics)
  • Gene expression

With the help of our well equipped and high quality Molecular Biology Laboratory we can perform all kinds of RNA and DNA work.

Outpatient Clinics
clinics

Our air-conditioned, comfortable clinic is situated at Balatonfüred, Hungary within easy access of both public transportation (bus, train) and car.

At the Clinic (Regional Osteoporosis Centre) Osteoporosis and diabetes consultations are performed with specialised MDs and qualified assistants.

The clinic basically accepts patients with GP offering, however they can also participate in different sorts of examinations (DEXA bone density measurements as well) for a certain charge. Osteoporosis Research and Clinic in Balatonfüred DEXA and Ultrasound Bone Densitometry GE Lunar DPX- Pro) Bone Metabolism (Bone Formation/ Resorption Markers ) and Resorption Laboratory Testing are performed.

Diabetes Research and Clinic Metabolic Unit

(Clamp studies)

Diabetes clinics serves the outpatient diabetics from the rural region and the cities on the north sore of the lake Balaton and from the four rehabilitation hospitals with total of 800 beds located in Balatonfüred.

Cardiovascular

Cardiovascular Research Laboratory and Clinic Exercise Testing ECG Holter Monitoring and ABPM Nuclear Medicine Facilities Cardiac ECHO Outpatients from the region and former hospital patients for follow up control. Clinic uses bicycle and tread-mill exercise performance testing, isotope diagnostic facility, cardiac ECHO and cathetherisation.

Population screening tests

Our institution regularly performs population screening tests in nearby towns with the help of local GPs as well as regional nurses and with the support of The National Public Health and Medical Officer Service (NPHMOS) We perform bone densitometry (heel)- and metabolism check as well as prostate tumor testing (glocose, cholesterol, blood pressure, weight, height and PSA).

creened patient receive medical advice and are referred to specialists for further tests or consultations.
Our institute repeatedly organizes informative lectures and trainings.

Reference

Our institute Phase I Unit
Therapeutic Area Type of Study Number of Volunteers
1 hormon replacement Pharmacokinetic study 24 patients with renal insufficiency
2 potassium replacement Bioequivalence / single dosing 24 HV
3 antibiotic Bioequivalence / single dosing 28 HV
4 antidepressant Method validation for interaction studies 18 HV
5 antihypertensive Bioequivalence / single dosing 24 HV
6 anticonvulsant Bioequivalence / single dosing 24 HV
7 antidepressant / alcohol Interaction study 24 HV
8 proton pump inhibitor Bioequivalence / food interaction 24 HV
9 proton pump inhibitor Bioequivalence / single dosing 32 HV
10 antihypertensive Bioequivalence / single dosing 36 HV
11 antidiabetic Bioequivalence / single dosing 24 HV
12 antixolitic /anxiolitic Interaction study 16 HV
13 proton pump inhibitor Bioequivalence / food interaction 32 HV
14 beta-blocker pharmacokinetic in elderly population 24 HV, elderly healthy volunteers
15 proton pump inhibitor Bioequivalence / food interaction 32 HV
16 anticonvulsant,thy neuropa Pharmacokinetic study 16 hepatic patients
17 NSAID Bioequivalence / single dosing 28 HV
18 Bronchial asthma COPD Pharmacokinetic study 24 hepatic patients
19 oral antidiabetic Phase I / multiple dose, dose ranging 36 HV
20 oral contraceptive Bioequivalence / single dosing 41 HV female
21 proton pump inhibitor Bioequivalence / multiple dosing 32 HV
22 antiallergic Pharacokinetic, pharmacodynamic study 8 HV
23 faecal incontinence Phase I / multiple dose, dose ranging 60 HV
24 liver function diagnostic PK study, single dose i.v. 12 HV
25 NSAID Pharmacokinetic study 11 hepatic patients, 12 HV
26 tofisopam / midazolam Interaction study 16 HV
27 levocetirizin Bioequivalence / single dosing 28 HV

COFOPEX LTD.
Bimbó út 92.
1022 BUDAPEST
HUNGARY

E-Mail: barai@mail.datanet.hu
mobile: +36 20 9357 867

 
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