Target SMO was founded in 2009 as part of Target Consulting Group Co, being the first site management company for clinical studies in Romania. Initially, the site management services were deployed only for non-interventional clinical trials, while Target delivered also services like data management and medical writing for Sponsors and CRO’s.
Due to our performance level and solid experience, we have been asked by our customers in recent years to extend these services also to phase 2 and 3 interventional clinical trials. In time, Target developed a national network of medical centers and investigators in various medical specialties, becoming a key catalyst of good cooperation between these and the Sponsors and CRO’s.
Our activity has at its core the aim of improved well-being for the patients. In clinical studies, we believe that a strong collaboration between investigators, medical centers, patients’ associations, regulatory authorities, CROs and pharmaceutical companies is the answer to achieve this. Implementing the recent new EU-CTR regulations may represent a challenge for the parties involved in clinical trials in our country.
This makes the proper communication, understanding and good cooperation between the parties key success factors. In order to support this and contribute to the successful implementation of the new EU-CTR rules, Target does organize among other dedicated events on the EU-CTR subject for the professionals involved in clinical trials.
Frequently Asked Questions
What is a SMO?
A Site Management Organization (SMO) is a provider that delivers operational and administrative support services to the clinical investigators at a research site. This includes everything from handling regulatory and compliance activities to managing patient recruitment and data collection. SMOs can also provide support with study start – up, monitoring and close – out. SMO services may include: identifying or managing investigators and sub-investigators, hiring study staff, preparing submissions to Institutional Review Boards, assisting with project feasibility, patient recruitment, study site initiation and other site-specific study activities. For more information, please see section “Services”.
Could external investigators and institutions, besides Romanian ones, collaborate with Target SMO?
We wish to create a multicultural network defined by commitment and quality. Therefore, we are open to collaborate with other SMOs and investigators from all Europe. If you want to be a part of our story, please contact us. (link/ buton spre sectiunea contact us).
What is a site?
A site is a place where clinical trials are conducted. This place could be a private medical centre, an hospital, a research institute or an university. The Sponsors choose only the sites which have the appropriate facilities for their studies. Target SMO could help the medical centres to respect all the standards required and to increase the quality of the services.
Could Target SMO help you to create a study team?
Our staff is highly trained for the role of Study Coordinator and for the management tasks. If you choose to work with us, we will allocate the best person for your site and your study. Also, we have a nurses network which can perform the specific procedures at the site or at the patient’s home. Even though your study is centralized or decentralized, together we could create the perfect team. For more information, please refer to the section “Services”, sub-sections “Site Management” and “Nurses Network”.
How could Target SMO support his partners for alignment at the new Regulation, EU-CTR?
Target could offer consulting for a good understanding and application of the EU-CTR principles. Our goal is to make the transition easier for everyone, therefore we organise special workshops and post the latest news about the subject on our website, also we can help your institution to register in SPOR-OMS (Please see section EU-CTR).
Why is important SPOR-OMS registration?
By registration in SPOR-OMS platform, a site received special IDs used for its identification and recognition in the CTIS, the system which represents the common portal for all information about the clinical trials conducted in Europe. On our website you could find a guide with detailed instructions for registration. For other queries contact us and one of our consultants will assist you.