Support the trial subject
At all times during the research project the trial subject or patient must be protected. Therefore it is essential that subjects are sufficiently made aware of the study, the purpose and duration, the procedures to be followed, the nature of the product to be tested, the expected benefits and possible risks involved.
Beside informing subjects on these and other relevant matters, Penthecilia will stimulate and monitor their therapy compliance and guarantee the safety of the trial subject by checking their vital signs, ECG, taking blood samples etc. We will carefully monitor the toxicity levels and side effects of the test product, analyze the collected data and report our findings. During the entire project we will ensure that all regulatory privacy regulations are observed.
Our services include:
- Informing subjects on the nature of the research project and the procedures to be followed
- Obtaining the informed consent of subjects before participating in the research project (informed consent interview)
- Stimulating and monitoring therapy compliance
- Performing physical check-ups on subjects, e.g. vital signs, ECG etc.
- Take blood samples, e.g. for pharmacokinetics
- Dispensing study medication and monitoring drug accountability
- Guaranteeing the privacy of the trial subjects
- Monitor side effects; recognize, document and report within the timeframes stipulated in the protocol
- Follow-up planning