Our Blog
Sermes CRO, first company to manage the submission of a clinical trial in Spain through CTIS
Sermes CRO, together with Mikrobiomik, manages the first submission of a clinical trial in Spain through CTIS (Clinical Trial Information System), the new European clinical trial’s portal.
By Sermes CRO
Sermes CRO has been the first Spanish clinical research company to present a study through the new European platform, the Clinical Trial Information System, CTIS. CTIS go-live last January was necessary for the EU CTR 536/2014 (European Union Clinical Trial Regulation) to come fully into force. It aims to make Europe a more competitive market for the clinical research industry.
The first clinical trial submitted via CTIS has been promoted by Mikrobiomik, a bio-pharmaceutical company pioneering clinical research and development of treatments based on intestinal microbiota. It aims to study the efficacy, safety, and tolerability of its leading product MBK-01 (freeze-dried microbiota faecal capsules) for the treatment of non-alcoholic steatohepatitis. Two Spanish sites, so far, are participating in this randomized, doble-blind, multicenter phase II clinical trial: Marqués de Valdecilla Hospital and Puerta de Hierro Hospital.
The new CTIS centralizes the submission and the whole documentation management of clinical trials in Europe. Its application aims to harmonize the clinical trial approval processes within the different European countries, as well as introducing common assessment criteria. There will be a three-year transition period in order to clinical research industry to adapt to CTIS.
Sermes CRO is the only Spanish company involved in the EMA’s working group on CTIS since 2017. It has also been certified by EMA as CTIS Train of trainers.
Sermes CRO, together with Mikrobiomik, manages the first submission of a clinical trial in Spain through CTIS (Clinical Trial Information System), the new European clinical trial’s portal.
By Sermes CRO
Sermes CRO has been the first Spanish clinical research company to present a study through the new European platform, the Clinical Trial Information System, CTIS. CTIS go-live last January was necessary for the EU CTR 536/2014 (European Union Clinical Trial Regulation) to come fully into force. It aims to make Europe a more competitive market for the clinical research industry.
The first clinical trial submitted via CTIS has been promoted by Mikrobiomik, a bio-pharmaceutical company pioneering clinical research and development of treatments based on intestinal microbiota. It aims to study the efficacy, safety, and tolerability of its leading product MBK-01 (freeze-dried microbiota faecal capsules) for the treatment of non-alcoholic steatohepatitis. Two Spanish sites, so far, are participating in this randomized, doble-blind, multicenter phase II clinical trial: Marqués de Valdecilla Hospital and Puerta de Hierro Hospital.
The new CTIS centralizes the submission and the whole documentation management of clinical trials in Europe. Its application aims to harmonize the clinical trial approval processes within the different European countries, as well as introducing common assessment criteria. There will be a three-year transition period in order to clinical research industry to adapt to CTIS.
Sermes CRO is the only Spanish company involved in the EMA’s working group on CTIS since 2017. It has also been certified by EMA as CTIS Train of trainers.
×