Services

Feasibility Management

We manage feasibility requests through a centralized process, collaborating closely with experienced investigators to ensure optimal outcomes. Each request is thoroughly evaluated to deliver a tailored and realistic assessment. Our team provides a carefully curated list of potential study sites from our extensive network, ensuring alignment with the specific requirements and objectives of each project.

Project Start-Up

MEDRIAL maintains a robust database to support efficient management of start-up documentation. Our locally based site research coordinators ensure the prompt preparation and submission of all required documents, enabling a fast, streamlined, and reliable start-up process.

Contract Management

Our centrally managed contract services ensure consistency and efficiency, coordinated through a dedicated single point of contact. We facilitate a streamlined contracting process by providing end-to-end support to sponsors, CROs, and investigators, accelerating negotiations and reducing administrative burden for all parties involved.

Quality Management

To uphold the highest standards across all clinical trials, we manage and monitor operational processes using a sophisticated CTMS. Each activity is guided by comprehensive SOPs with a strong focus on data integrity and patient safety. Regular internal audits ensure strict adherence to study protocols and GCP, while also driving continuous improvement across all processes.

Recruitment Support & Concept Development

Our extensive network of referring physicians and research centers across Armenia provides broad access to a diverse patient population, enabling us to meet recruitment targets efficiently even for rare conditions. With sites located in the country’s leading university hospitals, we offer access to a wide and diverse patient population. Patients with chronic conditions are closely monitored by their physicians, and securely stored in our internal database, facilitating seamless follow-up and long-term study participation. This close physician–patient relationship contributes to high enrollment rates and minimal dropout. We implement tailored recruitment strategies, including online marketing, digital recruitment campaigns, and direct cooperation with physicians. Our proven approach allows us to customize these approaches to meet the specific needs of each clinical trial, ensuring the best recruitment outcomes for even the most challenging studies.

Project Management

At MEDRIAL, project managers anticipate and manage risks to ensure the delivery of successful results on time, covering every aspect of the clinical trial process – from site feasibility, communication, and supply handling to study follow-up and final database lock. Our project managers serve as the primary point of contact, handling all communications with sponsors and CROs, ensuring smooth, high-quality recruitment studies. Additionally, project management supports both clinical research sites and CRAs. This direct communication is key to identifying potential risks early, enabling us to develop strategies to swiftly address any issues. Our team follows a proactive, solution-oriented approach, ensuring optimal project outcomes.

Our Training

MEDRIAL provides a comprehensive training program designed to strengthen the skills and expertise of our team. This includes everything from foundational GCP training to advanced, study-specific instruction. We also support investigators and key stakeholders with targeted guidance to overcome recruitment challenges, ensuring high-quality performance and strict adherence to study protocols.

Privacy & Data Protection

With the implementation of the General Data Protection Regulation (GDPR) on May 25, 2018, privacy and data protection have become critical aspects of our work. CLINÉCA actively supports its sites in developing and implementing standardized data protection protocols to safeguard patient information. We are committed to ensuring compliance with privacy regulations across all network sites, offering guidance and templates to ensure secure patient interactions.

Daily Activities at the Sites

• Under the guidance of the investigators, MEDRIAL’s highly skilled site research coordinators handle a variety of non-medical tasks, constituting 70-80% of the total clinical trial workload. These activities include:
• Contact with Independent Ethics Committees (IEC) and assistance with document submissions.
• Protocol and GCP compliance.
• Reporting and tracking safety information.
• Quality control oversight.
• Logistics management, including subject visits, CRO and sponsor visits, drug accountability, and lab sample handling.
• Management of study files, eCRF data input, and query resolution.
• Data cleaning, inventory management, and project file archiving.