NEW: QMS development and GCP audits
"Without standards, there can be no improvement" (Taiichi Ohno).
SynCRO provides consultancy for clinical research sites in the development of Quality Management System (QMS) and site-specific clinical research Standard Operating Procedures (SOPs).
In addition, we can perform GCP investigational site audits and vendor qualification audits anywhere in the world.
Patience is bitter, but its fruit is sweet
As you may already know (or have experienced), during the last years there were considerable delays in clinical study approval times in Romania which led to a decrease of Sponsors'/CRO's interest to conduct clinical trials in our country.
Clinical research was limited to VHP trials and therapeutic indications in which Romania could not be bypassed or excluded due to its large patient pool.
Towards the end of 2018 the Romanian Regulatory Authority have realized that very prompt and urgent measures must be taken in order to normalize the situation: yesterday, 3rd of June 2019, the RA communicated on their website that they are in the process of eliminating the delays in clinical study approvals.
Please find below the link to the RA communication (in Romanian language), where you can also find a table with their progress, which seems very promising:
Bearing in mind the positive attitude and the actual measures taken by the Romanian RA, it is the right time to (re)start clinical trial projects in Romania.
Regulatory approval times improving!
A communication from the Romanian regulatory authority 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. According to this communication in the last two months from 2018 an average of 48 application & submission files have been analyzed, compared to an average of 9 files during the first 10 months of the year.
We are glad that finally this prioritization have been made and we hope it will lead to the normalization of the approval times and the increase of the Sponsors' interest for Romania.
You may find the original announcement (in Romanian) on the ANMDM's website:
ISO 9001-2008 Certificate obtained
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. We consistently endeavour to go beyond providing services that just meet GCP and regulatory requirements. We invest in quality management systems and continuous evaluation of our services.
DAI-SYS CRO member for Romania
Syncro was accepted as the DAI-SYS CRO member for Romania. DAI-SYS is an organisation operating on a global scale linking selected local CROs, specialists services and relevant information sources to assist bio-product developers.
New website launchedSyncro's new website is up and running!