Selected procedures

Preparation of study documentation

We prepare the following study documents:

• Study Synopsis and Protocols
• Subject Informed Consent Forms (ICF)
• Case Report Forms (CRF)
• Study reports in CTD format
• Subject diary
• Source data (between others: screening forms, subject cards, tests referrals ect.)
• Study specific Instructions and Logs
• Other documents related to the procedure of study registration

All documents are prepared in Polish or English.
We translate the study documentation.
Experienced medical writer is a member of our team.

Study management

• Study management by experienced Project Managers/Coordinators
• Close cooperation and communication with a Sponsor (including periodic written reports on the study progress)
• Reach and qualification of clinical sites (in case of multi-center studies)
• Preparation and signing of agreements with sites and investigators
• Preparation and submitting documentation to Independent Ethics Committee and regulatory authorities (CEBK-), constant communication with these institutions
• Obtaining EudraCT number
• Training sessions for study teams
• Monitoring of clinical sites all over Poland ( in case of multi-center studies)

Subjects' recruitment

• Recruitment of healthy subjects from own, registered database
• Recruitment of subjects by physicians of various specialties, who cooperate with the company

Informed Consent

• Informing study participants by an investigator, in accordance with GCP guidelines
• Signing of the Informed Consent Form in presence of an investigator

Medical procedures at MTZ Clinical Site

• Medical history and demographic survey
• Physical examination and BMI definition
• Vital signs measurements
• Various methods of administration:
  • oral
  • parentral
  • rectal
  • transdermal
• Collecting of blood and urine samples, including 24-hour urine collection, also other biologic materials
• Tests performed by own laboratory:
  • drug screen in urine
  • nicotine screen in urine
  • alcohol in exhaled air
  • pregnancy tests
• 24-hour professional medical supervision
• Defined procedures in case of emergency
• Monitoring and reporting of adverse events (AE)
• ECG recording
• Availability of constant vital signs monitoring (between other tele-ECG)

All binding procedures are highly standardized, described in SOPs and instructions and are subject to regular, periodic internal audits.

Specialistic procedures

• Specialist physical examination required by protocol (e.g. ophthalmic, dermatological, gynecological)
• High resolution skin pictures , high standardization and professional assessment
• Collecting samples of the stratum corneum of epidermis (stripping method)
• Tests:
  • chromameter - do evaluate skin color
  • corneometer - to measure skin hydration
  • tewameter - to evaluate efficiency of the skin water barrier
  • cutometer - to evaluate skin elasticity
  • sebumeter - sebum measurement
  • pH-meter - to evaluate skin pH
• Defining MED
• Spirometry
• Tele ECG