Study budgeting, feasibility, site recruitment
SynCRO has collaboration 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
During the last years there were considerable delays in clinical study approval times in Romania which led to a decreased interest to conduct clinical trials in our country. Towards the end of 2018 the Romanian RA have realized that very prompt and urgent measures must be taken in order to normalize the situation.Read more
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