Today, we offer access to most fruitful and ever growing clinical research markets of Ukraine. Our primary service domain is within clinical trials conduct and investigational sites management. The services cover various aspects – investigational site start-up, enrollment facilitation, data and quality management, and many others. You can grasp them at a glance in the list below, but if you’re interested to learn about our services more we’d be glad to provide you with detailed information.
Regulatory Services:
- Protocol submission to RA;
- Central Ethics Protocol approval;
- Patients' and Investigators' Insurance;
Easy Site Start Up:
- determining site feasibility;
- development of site regulatory documents;
- Local Ethics Committees (ECs) submissions;
- providing sites with office equipment (on demand);
- identification and contracting of external facilities to perform study procedures (e.g., central Lab facilities, IMP depo facilities, etc.).
Assisting sites with staff:
- recruitment of qualified site coordinators, sub-investigators and consultants;
- trainings for site staff.
Site Management & Monitoring:
- on-site monitoring visits;
- distant (office-based) monitoring;
- risk-based monitoring;
- data-management.
Ensuring Enrollment:
- development, production and distribution of recruitment materials;
- patients referral management;
- patient recruitment strategies (identification of potential clinical trial subjects and referral sources located close to the site)
- visits management and boosting communication;
- identification and elimination of site specific issues/hurdles preventing sites from good enrollment;
- review of site enrollment targets and follow-up of correction actions;
- site engagement programs;
- pre-screening assistance.
Patient compliance and retention:
- assistance with transportation of study subjects to site facilities for visits;
- patients travel reimbursement;
- patients visit management;
- patients engagement and patient-driven events;
- patients compliance and counseling, at-risk & incompliant patient tracking;
- management of patient compliance challenges.
IMP Depot:
- IMP Depot;
Central laboratory:
- Central lab;
Site contracts:
- counseling during negotiation of contracts;
- legal review of contracts;
- accounting site payments.
Project management:
- site coordination;
- provide a liaison between Sponsor/CRO and investigators;
- quality control of study procedures and documentation of study visits;
- follow-up of monitoring visit findings action plans;
Data management:
- CRF completion on behalf of investigators;
- Resolutions of data queries;
- Site IT support;
- Work with electronic study systems on site’s behalf.
Assistance with proper Safety reporting:
- Investigator support in SAE reporting;
- Submissions to ethics committees.
Quality management:
- assistance during audits and inspections;
- site SOP writing and implementation;
- site performance assessments.
Clinical trial communication:
- translation and sharing of study newsletters;
- facilitating direct communication between Sponsor and clinical sites;
- promotion and implementation of Sponsor’s initiatives, development of initiatives on Sponsor’s behalf;
- education of clinical sites personnel;
- reporting to Sponsor of site specific and study-related issues that might affect site performance.
Pharmacoeconomics:
- preparing localized pharmacoeconomics reports;
Medical Services:
- Review of study protocol and amendments;
- Selection of KOLs and National Study Curator;
- Conducting scientific interviews with KOLs;
- Medical support in CRF design;
- Development of the study specific tools;
- Trainings on the study protocol to Investigators and CRAs;
- Representing the sponsor interests with ECs and RA
- Services of Study Physician, Safety Physician;
- Medical Reviewer for the study
- Medical information support