Study budgeting, feasibility, site recruitment
SynCRO has its own database with qualified investigators in all major therapeutic areas from Romania, Hungary and Moldova.
Regulatory affairs, ethic committees
+ Preparation of documents and submission to regulatory authorities and ECs
+ Timely reporting of SUSARs, SAEs.
Drug import, site initiation
+ Drug import and distribution to centers
+ Site initiation / training of investigators
Project management, study coordination, monitoring
+ Trial site management / site supplies (laboratory kits, CRFs)
+ Continuous assessment of investigators' compliance with GCP / regulatory requirements
Clinical Data Management and Biostatistics
Syncro is providing Clinical Data Management and Biostatistics services through it's partner, AdWare Research.
AdWare Research was established in 1997 and it is a dynamically developing pre-clinical and clinical data-management and biostatistics provider company. AdWare provides its service in compliance with the national and international regulations, and possesses the relevant GLP, RA certificates.+ Data-management and biostatistics
Its main activities are:
+ Quality assurance
+ Independent audit
+ Education and consultancy
With its strategic partners AdWare can undertake whole-scale project management.
The data-management services are provided by its own developed Mythos data-manager software that fulfills the criteria of FDA CFR 21 part 11.
For more information please visit: www.adwareresearch.com
A communication from the Romanian Regulatory Authority (ANMDM) website from 15-Jan-2019 states that the RA have prioritized and is committed to reduce the delays in approval times, for all types of applications / submissions.Read more
Syncro was ISO 9001-2008 certified on 2nd of June 2014 as a Clinical Research Organisation, involved in the setup, conduct and management of clinical trials. This certification is a sign of our commitment to deliver high quality services to our partners.Read more