- Bioequivalence
- Phase I & II studies
- Phase III (in cooperation)
- Phase IV (in cooperation)
Bioequivalence (BE)
We will professionally assist you in the finding
of appropriate, well-trained and reasonably priced
clinical site. The head of our BE section in the
past run successfully several BE studies. We have
good connections with the professional staff, both
in the country and abroad.
Presently, we will help with preparation of
the protocol, preparation of CRF and we can take
care of the organization of the study. Also
integrated final report and archiving - we only
need your drug and willingness to cooperate.
Phase I, II, III & IV studies
It is enormous task to perform these studies. We
would like to help you. To find the appropriate clinical
site. To help with recruitment of patients. Perhaps
the most important help is preparation of informed
consent (IC) for the patient. This is a difficult
not only from the point of view of individual patient
but also - even more importantly for your aim - from
the point of view of Ethical Committees. These
bodies are now very meticolously checking each sentence
of informed consent. We perfectly will translate
your IC and if you wisely allow us check IC for correctness
during preparation in English. Such approach can
save you months of valuable time. Cooperation with
us could be important.
Our service include: statistics of clinical
trial, preparation of the protocol, preparation of
CRF & informed consents, registration
of clinical trials with the Agency, organization of the study,
service during study, preparation of integrated final
report, archiving.
Our experience: participation (statistics protocol,
CRF, informed consent, integrated final report) in
several phase I studies successfuly accomplished. |