Study fit and start-up
Can SiteLink support our study regardless of phase or design?
Yes. SiteLink provides site-level execution for Phase I through Phase IV, interventional and observational, including post-authorisation safety studies. The operational model, the SOPs and the SiteLink Patient Management System are the same across phases; only the visit density, sampling logistics and follow-up horizon change. Send the synopsis and we will confirm feasibility for the specific design.
How does SiteLink contract with a CRO or sponsor?
Through a single scope of work per study, with SiteLink as the counterparty for the site-level services and the principal investigator retaining the investigator agreement. One point of contact, one invoice stream and one set of KPIs for every site we operate on the study. Where the sponsor prefers a tripartite clinical trial agreement, we work within that structure.
What should a feasibility request include, and what information do you return?
Send the protocol synopsis, inclusion and exclusion criteria, target enrollment and timelines to info@sitelinkeu.com. We return the completed feasibility questionnaire in the CRO or sponsor template, with investigator availability, a realistic patient-population estimate from the sites we operate and any protocol-specific constraints flagged up front rather than at site initiation.
How do you protect start-up timelines in Bulgaria?
Site-level documents for the EU Clinical Trials Regulation Part II package, ethics committee submissions and the investigator site file are prepared in parallel with contract and budget negotiation, not after it. Start-up tasks are tracked per site with named owners, and the CRO receives a status view rather than a status meeting. The study-level CTIS submission remains with the sponsor or CRO.
Visit delivery and oversight
How does SiteLink keep enrolled patients on schedule and in window?
Every visit is planned in the SiteLink Patient Management System from the Day 1 anchor with its protocol window. Coordinators see upcoming and at-risk visits per patient, and each patient receives an automated SMS or email reminder before the visit with the confirmed date and time. Reminder delivery is recorded per patient, so retention effort is evidenced, not asserted.
What visibility does the CRO or monitor get into site performance?
Enrollment and visit status are available on request in the format the CRO uses for its own tracking, and the principal investigator has a real-time study-wide view in the platform. Monitors are supported with organised source, a current investigator site file and continuous temperature records, so monitoring visits and remote source data verification proceed without reconstruction.
How do you ensure data quality and query turnaround?
Source is completed at the visit, entered into the sponsor EDC within the agreed window and reconciled against source before queries arrive. Queries are answered against source, not memory. A field-level audit trail in the platform records who changed what and when for every patient record, which supports both internal QC and ALCOA+ expectations during inspection.
How are investigational product storage and visit rooms temperature-monitored?
Every refrigerator, freezer and patient visit room at the sites we operate carries a calibrated digital sensor reporting continuously to a locally hosted, open-source automation platform (Home Assistant) that SiteLink runs itself. Each time-stamped reading is stored; minimum, mean and maximum are plotted over 24 hours, 7 days and 30 days; threshold alerts fire the moment a limit is crossed. There are no paper logs and no transcription, and the record is available to the monitor or inspector for the life of the study in one format across every site.
People, data and collaboration
Are your staff GCP-trained and how is delegation handled?
Coordinators hold current ICH E6 (R3) GCP training and are added to the delegation log by the principal investigator before performing any study task. Training records and CVs are maintained in the site file. Role-based access in the platform mirrors the delegation log, so a coordinator sees only the studies and functions delegated to them.
How do you handle personal data and GDPR?
Bulgaria is an EU member state and SiteLink operates under the GDPR. Patient data is held on infrastructure controlled by SiteLink, access is role based and logged, and reminder messages carry only what the patient needs to attend. Sponsor and CRO data-processing terms are incorporated into the scope of work.
Can SiteLink operate more than one site for the same study?
Yes. Each site keeps its own investigator, delegation log and site file, while SiteLink applies one set of SOPs, one platform and one reporting format across all of them. For the CRO that means a single operational counterpart in Bulgaria and consistent quality between sites.
What is the fastest way to start a conversation?
Email info@sitelinkeu.com with the therapeutic area, phase, expected timelines and the sites or regions under consideration. That address is monitored by the people who run the sites, and it is the only contact channel we use.
