On the basis of over ten years of experience in the line
of clinical trials, we offer professional and complete services in the scope of
clinical projects phase II-IV coordination including:

verification of correctness and completeness of study documentation including guidelines of local law regulations

selection and evaluation of potential study sites

preparation and submission of study documentation to Ethics Committee and Central Register of Clinical Trials

preparation and training of sites before project initiation

coordination of cooperation of institutions engaged in the project

regular monitoring of study sites with particular stress placed on:regular monitoring of study sites with particular stress placed on:
- consistency of patient inclusion criteria to project
- reliable verification of source data and its conformity with entries in Case Report Forms
- cooperation in serious adverse events reporting
- supervision over an investigational product
- supervision over all institutions additionally involved
in the project

checking of archived documents

drug accountability and authorized destruction
of unused medication

site close-outs
offer concerns Poland, Ukraine, Czech and Slovakia
more...