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
