Dear Ladies and Gentlemen,
On the basis of over ten years of experience in the line of clinical studies, we offer competent and comprehensive services in the scope of clinical projects coordination starting with:
verification of correctness and completeness of study documentation
with regard to guidelines of local law regulations
selection and evaluation of potential study sites
preparation (including translations) and submission of study documentation
to Ethics Committee and Central Register of Clinical Trials
preparation and training of study centers before project commencement
(meetings for Investigators, additional refresher trainings in Good Clinical Practice, site initiation visits)
further:
coordination of cooperation of institutions engaged in the project
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
until the stage of:
final Data Clarification Forms resolution with regard to CRF entries
checking of archived documents
drug accountability
site close-out
Licząc na możliwość nawiązania w współpracy proszę o kontakt: mc@monicare.pl
lub telefonicznie +48 509 45 40 78
