Experience & Quality

EN ISO 9001:2015 Certification

Mag. Andreas Raffeiner GmbH – certified according to the quality standard ISO 9001:2015!

As an external service provider, we maintain high quality sustained by our partner firms in our internal processes as well.

Hence, we started setting up a documented quality management system consistent with the ISO 9001:2000 requirements already in early 2006. Since to date no experience has been gathered in Austria in regards to our very specific business sector (external monitor, external CRA, freelancer), this is a very unique challenge for our company. Hence, it is a special privilege to be able to announce that our company

successfully completed the certification process on October 30, 2006.

This certification procedure consists of a detailed review of all quality-relevant company processes. Obtaining the ISO certification is yet another statement about the standards of our quality management, offering guarantees to our clients that every individual business operation carried out by Mag. Andreas Raffeiner GmbH corresponds to the norm and meets the high quality requirements of the ISO standard.

Quality Austria carries out yearly external audits in order to ensure the actual adherence to the quality management system as well as its further development.

Upon request, we will be happy to provide you with a basis for this certification – The Management Manual of Mag. Andreas Raffeiner GmbH (Trade register No.: 416 / 6485 BH Urfahr – Umgebung).

Experience and therapeutic areas

 

GASTROENTEROLOGY (> 900 Patients)

  • Dyspepsia
  • H. pylori eradication
  • Gastro-esophageal reflux disease (GERD)
  • Stomach protection in NSAID use
  • Peptic ulcer bleeding
  • Chronic inflammatory bowel disease
  • Hepatitis C

HÄMATOLOGY (>400 Patients)

  • Prophylaxis for deep vein thrombosis (DVT) and pulmonary embolism following extensive orthopedic surgeries

RHEUMATOLOGY (>350 Patients)

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Systemic juvenile idiopathic arthritis
  • Systemic lupus erythematosus (SLE)
  • Polymyositis

DERMATOLOGY (>100 Patients)

  • Dermatomyositis
  • Psoriasis
  • Contact dermatitis

BONE DISEASES (>400 Patients)

  • Osteopenia and osteoporosis
  • Osteoarthritis

METABOLIC DISEASES (>100 Patients)

  • Diabetes mellitus type 2

RESPIRATORY DISEASES (>1000 Patients)

  • Bronchial asthma
  • COPD
  • Seasonal allergic rhinitis (hay fever)
  • Acute bronchitis

CARDIOLOGY (>400 Patients)

  • Hypertension
  • Heart failure
  • Cardio-renal end point study in diabetes mellitus type 2
  • Antithrombotic therapy following STEMI and NSTEMI

NEPHROLOGY (>200 Patients)

  • Dialysis and peritoneal dialysis
  • Pre-dialysis
  • Treatment of anemia in chronic kidney disease
  • Immunotherapy following renal transplantation

NEUROPATHY (>100 Patients)

  • Chronic low back pain

CENTRAL NERVOUS SYSTEM (>100 Patients)

  • Schizophrenia
  • Acute ischemic stroke
  • Alzheimer’s disease
  • Japanese encephalitis
  • Depression
  • Multiple sclerosis

ONCOLOGY (>250 Patients)

  • Breast cancer
  • Colorectal cancer
  • Prostate cancer
  • Endometrial cancer
  • Ovarian cancer
  • Cervical cancer

OPHTHALMOLOGY (>5 Patients)

  • Pathologic Myopia

IMMUNOLOGY (>90 Patients)

  • The flu
  • H5N1 virus

STUDIES ON MEDICINAL DEVICES

  • Rhinopharyngitis / rhinitis in children (> 200 patients)

NON-INTERVENTIONAL STUDIES

IN THE CLINICAL THERAPEUTIC AREAS:

  • Rheumatology (> 800 patients)
  • Metabolism (> 800 patients)
  • Psychiatry (> 150 patients)
  • Nephrology (> 100 patients)
  • Dermatology (>50 patients)