Clinical trials in High-Med – information for Pharma companies and CROs

Physicians from private outpatient clinic High-Med conduct clinical trials phase II, III and IV in accordance with ICH- GCP requirements and provide specialist medical care.
Following investigators are experienced in clinical trials and research:

• Dorota Bystrzanowska MD – dermatology and venereology
• Prof. Hanna Wolska MD, PhD – dermatology and venereology
• Kamila Padlewska MD, PhD – dermatology and venereology
• Małgorzata Godziejewska-Zawada MD, PhD – endocrinology and diabetology
• Iwona Szczupacka MD – gynecology
• Jacek Borowicz MD – gastroenterology, infectious diseases and densitometry
• Krzysztof Kłos, MD, PhD – allergology, immunotherapy / vaccines, pulmonology

Our co-investigators also have considerable experience in clinical trials and research.
Investigators from High-Med have taken part in over a dozen clinical studies in following indications:

• dermatology (psoriasis, psoriatic arthritis, atopic dermatitis, acne, rosacea, mycosis)
• allergology (asthma, atopic dermatitis, idiopathic urticaria)
• immunotherapy
• endocrinology (hyperprolactinemia, diabetes)
• gynecology (hormone replacement therapy – HRT, premature childbirth, decrease in bone mass during lactation)
• gastroenterology

High-Med can also conduct clinical trials in:

• psychiatry
• orthopaedics
• neurology

All site personnel i.e. physicians, nurses, and study coordinator are being permanently trained according to Good Clinical Practice (GCP).
High-Med was audited by sponsors of clinical trials, and every time judged very positive and as a site which met GCP standards.
High-Med is considerably experienced in:

• central laboratory
• eCRF (DataLabs, Medidata Rave, Phase Forward)
• Clinphone, IVRS, IWRS
• professional imagery – e – CASE
• skin biopsy
• allergen immunotherapy
• ECG
• spirometry

If needed in clinical study, we can cooperate with the local laboratory, pharmacy, and department of diagnostic imaging and radiology (X-ray).

In High-Med clinic are 6 consulting rooms, treatment room, waiting room, and a reception desk. Patients’ source notes and study documents are stored in a separate, monitored and locked room. Access to this room is limited.
Besides that, High-Med possesses certified and validated equipment:
ultrasound scanners, refrigerators, freezer, electronic scales, thermometers min/max, glucometers, centrifuge.
Access to internet (wi-fi), phone and fax lines, copy machine and scanner is available in our clinic.
Also, separate room / working space for CRAs is provided.

High-Med has considerable experience in contacts with Ethics committees regarding registration and conducting the clinical trials in Poland.

For all information regarding cooperation with our clinic, please contact: dorota.bystrzanowska@high-med.pl