Phases II and III
The clinical centre conducts multicentre international Phase II and III studies. Phase II studies determine the dosing regimen, the dose and the efficacy of a medicine in a specific disease: the medicine is compared with placebo or with standard treatment. In Phase III, it is studied in a broader group of patients to confirm efficacy, tolerability and safety before registration.
What matters to sponsors and contract research organisations (CROs):
- Our staff work with electronic data capture systems (experience with leading electronic systems and databases), so they join a project more quickly.
- Strict adherence to procedures and timely documentation are the basis for meeting obligations to the client.
- We estimate realistic patient enrolment rates in advance, at the feasibility assessment stage.
Phase IV
Phase IV takes place after a medicine is registered. It collects additional data on safety and on interactions with other medicines, and follows therapy in routine practice. The centre has experience of observational post-marketing studies at its own site. A standard of timely documentation helps to collect data quickly and to respond promptly to queries.
Medical fields
The clinic conducts studies of medicines for various medical fields; for details, see the Experience page.
How to start
Send us a synopsis or protocol. We will check the inclusion criteria, procedures and enrolment rate, then prepare a budget and a schedule. Send us a request or call us.
Questions and answers
How do Phases II, III and IV differ?
Phase II finds the dosing regimen and assesses efficacy in patients with a specific disease. Phase III confirms efficacy, tolerability and safety in a broad group of patients. Phase IV is a study after the medicine is registered: it collects additional data on safety and on interactions with other medicines.
See also
Feasibility assessment of a clinical study
A feasibility assessment is a review of the protocol before a study starts. It shows whether the study can be run at the site within the required timelines and with the required number of participants. The clinic carries out this assessment for sponsors and contract research organisations (CROs).
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Taking part in clinical studies: for patients
Taking part in a clinical study is voluntary. The patient is told about the purpose of the study, the procedures, the risks and the possible benefits, and then signs informed consent. During the study, doctors supervise the patient.
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Quality management system
Participant safety and data reliability are ensured by a quality management system: standard operating procedures, internal and external audits and regular staff training.
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