“Driven by innovation, inspired by wellness — Gliatech creates intelligent health solutions designed to simplify and elevate everyday well-being.”

Our Clinical Trial experts are instrumental in managing and overseeing all phases of clinical studies-from initiation to close-out. Through regular coordination with study teams and the use of our proprietary Clinical Trials Management System (CTMS), they ensure real-time tracking of study progress, patient enrolment, site information, and key regulatory deadlines and milestones.

Our Clinical Research Associates (CRAs) are responsible for conducting comprehensive site visits and ensuring high standards of compliance and quality across all trial activities. Their responsibilities include:

1. Coordinating study and site start-up activities
2. Supporting IRB/EC submission and meeting processes
3. Ensuring adherence to study protocols, SOPs, contractual obligations, and budgetary requirements
4. Monitoring subject screening and enrolment procedures
5. Managing SOPs and regulatory documentation (both electronic and paper-based)
6. Preparing and maintaining monitoring visit reports, calendars, and schedules
7. Overseeing safety reporting and regulatory submissions
8. Verifying informed consent forms are properly signed and archived
9. Conducting Source Data Verification (SDV) in accordance with protocol and monitoring plans
10. Reviewing eCRFs/CRFs with site personnel to identify trends and serious adverse events (SAEs)
11. Performing investigational product accountability
12. Auditing investigator site files for accuracy and completeness
13. Providing ongoing guidance and support to clinical sites to ensure successful trial execution

Ensuring patient safety and effectively managing serious adverse events (SAEs) are critical components of a successful clinical trial. At GliaTech, our team of experienced clinical research physicians brings deep medical expertise to evaluate safety concerns as they arise, supporting a robust and proactive risk management strategy throughout the study duration. GliaTechoffers a comprehensive and adaptable suite of drug safety services for clinical trials, including:

1. Coordination and management of Data Safety Monitoring Committees (DSMCs)
2. 24/7 assessment and reporting of Serious Adverse Events (SAEs)
3. Expert medical review of adverse events and all trial-related safety data
4. Preparation of Development Safety Update Reports (DSURs)
5. Safety notifications for Investigators and Ethics Committees

At GliaTech, we ensure the highest level of data integrity through strict compliance with industry-standard data management operating procedures. By working in close collaboration with our partners, we deliver accurate, high-quality data within project timelines, while maintaining full adherence to Good Clinical Data Management Practices (GCDMP).

Our Clinical Data Management services include:

1. Comprehensive EDC system training for sites and monitors
2. System validation to ensure compliance and performance
3. Design and development of eCRFs and paper CRFs
4. Preparation of essential data management documentation (DMP, DVP, DMR, etc.)
5. Database setup, data entry, medical coding, validation, and cleaning
6. Import, integration, and cleaning of electronic data (e.g., lab, ECG, PK, diary)
7. Reconciliation of SAE, lab, ECG, imaging, and other clinical data
8. 24/7 EDC helpdesk support
9. Secure web portal for real-time access to study progress, queries, subject data listings, and summary tables
10. Ongoing user support, including training and helpdesk assistance
11. Data migration services
12. Database lock and archival processes

GliaTech is committed to delivering reliable, high-quality clinical data that supports the success of your trials.

At GliaTech, our Quality Assurance (QA) team is committed to upholding the highest standards by conducting periodic audits across various clinical trial processes, thereby supporting the development and maintenance of a robust Quality Management System (QMS). In close collaboration with our clients, the QA team ensures that service requirements and project scope are clearly defined and aligned with regulatory expectations.

GliaTech offers a comprehensive range of QA services designed to ensure compliance with regulatory authority requirements for clinical trials, including:

1. Vendor and Investigator Site Audits
2. System and Study Audits (e.g., Pharmacovigilance, Clinical Databases)
3. Clinical Study Report and Trial Master File Audits
4. Protocol and Investigator Brochure Audits
5. Clinical Laboratory Audits
6. Pre-inspection Audits
7. Standard Operating Procedures (SOPs): Development, Review, and Updates
8. Quality Management System (QMS): Development, Review, and Maintenance

GliaTech offers comprehensive end-to-end regulatory support for clinical trials. We manage the preparation, submission, and follow-up of clinical trial applications in compliance with the requirements of relevant regulatory authorities (RAs).

Our regulatory services include:

1. Coordination between investigators and Institutional Review Boards (IRBs) or Ethics Committees (ECs)
2. Submission of Development Safety Update Reports (DSURs), Serious Adverse Events (SAEs), and other mandatory reports in accordance with RA guidelines
3. Preparation and submission of clinical study reports
4. Study transparency and disclosure management
5. Regulatory support for the import, supply, and oversight of investigational products
6. Import/export permissions for investigational products and biological samples

Investigational Product Management:

1. Local labeling design and regulatory compliance
2. Storage, distribution, return, and destruction of investigational products
3. Coordination and oversight of third-party service vendors