Our Services
Records Management
Nurses National Network
Medical Monitoring
Project management for Non-Interventional studies
Site Feasibility
Optimization of feasibility process as we collaborate with Institutions and Investigators in multiple locations across Romania.
Rapid site identification based on the requirements of Sponsors/ CROs. Recommendation of suitable sites from our network for a specific study protocol. Support our sites to provide fast answers to feasibility questionnaires received from Sponsors/CROs.
Provide historical data on patients’ profile for specific indication.
Implement pre-screening activities.
Provide input for protocol feasibility (e.g: eligibility criteria that are not medically significant but may drastically limit its enrollment, some local particularly treatment protocol etc).
Site Management
Provide operational and administrative support to the Principal Investigator (PI) at study site.
Allocate highly trained Site Coordinators (SCs) at study site who are delegated by PIs to perform administrative and non-medical study activities.
Allocate highly trained Site Coordinators (SCs) at study site who are delegated by PIs to perform administrative and non-medical study activities.
Site assistance in completing the required documentation in due time for EC/ RA submission.
Budget negotiation with site and third-party vendors for procedures and investigations in accordance with study protocol.
Contract negotiation and finalization in compliance with local regulations. Payment process optimization: calculating site staff fees, invoicing expenses and pass-through costs, ensuring the payments are done in accordance with local tax requirements.
Support site staff for timely and adequately training (GCP and protocol specific).
Support the site to meet the agreed patient recruitment rate and implement measures to ensure patient retention and treatment compliance.
Technical support for systems access and data entry (EDC, IWRS, etc.).
Provide rapid response to the queries and requests received from Sponsors/ CROs.
Support timely safety reporting through-out the study duration.
Collaborate with Sponsors/ CROs monitors to ensure efficiency of the monitoring visits from the site initiation until site close-out.
Regulatory
Management of local ethics committees communications / submissions.
Prompt completion of site documents and forms for National Ethics Committee and Regulatory Authority submissions.
Ensure the site is registered in the CTIS for studies submitted under EU-CTR procedure.
Timely compilation/ editing / upload of documents required for submission according to EU-CTR.
Scientific support
ICH – GCP – Good Clinical Practice training and customized study protocol training for each study team role.
Creation, implementation and revision of Standard Operations Procedures for Institutions according with ICH-GCP and local legislation.
Records management
Setting up and maintaining the paper or electronic Investigator Site File (ISF), according to GCP and Sponsor SOPs.
Ensure that the ISF is updated throughout the duration of the study.
Perform periodic quality checks and reconciliation with the Sponsor TMF to ensure completeness of the expected documentation and reduce TMF operational burden.
Review of the ISF to assess inspection / audit readiness.
Perform archive procedures upon study termination in accordance with the Clinical Trial Agreement.
Nurses national network
National study nurses’ team to support decentralized clinical trial activities in multiple locations across Romania.
Experienced research nurses with background covering a broad spectrum of therapeutical areas.
Medical Monitoring
Review of clinical trial data by qualified personnel with medical background, according to the needs of the Sponsor / CRO.
Verification of subject eligibility based on the review of eCRF data.
Monitoring of safety information collected during the clinical trial and cross check of adverse events and concomitant medications.
Project management for Non-Interventional studies
FAQ
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.