Syncro is specialized in site selection, regulatory affairs and clinical trial monitoring. We have the know-how and experience for the setup and management of clinical trials in Romania. Either you choose all the below listed services for Romania, or you decide to select only one segment outsourced to Syncro, we can strongly affirm that you will not be dissapointed of our performance.
Study budgeting, feasibility studies, site recruitment
SynCRO has its own database with qualified investigators in different clinical specialties: oncology, cardiovascular medicine, diabetes, internal medicine, neurology, ophthalmology, E.N.T., orthopedic surgery and medical devices.
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