Clinical Studies
Our experts have more than 25 years of experience in preparing, realizing and evaluating clinical studies in many therapeutic areas (oncology, dermatology, gastroenterology, psychiatry, neurology, internal medicine, parenteral nutrition, critical care medicine, etc.), and more than 40 years of experience in experimental and/or clinical research. We have participated in the clinical development of a series of marketed, original drugs (Hypotylin, Migrenal, Meclopin, Mysalfon, etc.) and numerous successful generics (ranitidine, alprazolam, diclofenac, hymecromone, ketotifen, mephenoxalone, naftidrofuryl, silymarin, oral transfer factor, diltiazem, terbinafine, ketoprofen, etc.).
The department of clinical pharmacology offers realization of phase I-III (IV) clinical trials according to GCP. We offer:
- Provision of all the documents necessary for submitting the application for approval of clinical evaluation of a new drug to the relevant authorities
- Handling of communication with the state authority (SÚKL) and ethical committees
- Arrangement of all documents necessary for the studies to be conducted according to GCP principles: development of study protocol, investigator´s brochure, patient’s information, patient’s informed consent, elaboration of CRFs, etc.
- Arrangement of study insurance, contracts with hospitals and physicians and payments to volunteers
- Complex study monitoring and study audits
- Statistical evaluation of results, their clinical interpretation and the redaction of final reports
