At EPINTEK, we provide professional clinical trial monitoring services to ensure the highest standards of quality, compliance, and data integrity throughout the medical device clinical trial process. As outlined in the Good Clinical Practice (GCP) Guidelines for Medical Device Clinical Trials, monitoring is an essential component of any clinical study. Our experienced team of monitors supports sponsors in fulfilling regulatory requirements and maintaining scientific rigor across all trial phases.

Comprehensive Clinical Trial Monitoring Services

Our monitoring services strictly follow the Standard Operating Procedures (SOPs) established by the sponsor and are designed to ensure that clinical trials are conducted in accordance with the protocol, applicable regulations, and ethical principles.

Key Responsibilities of Our Monitors Include:

1. Pre-Trial Site Readiness Assessment
We verify that each clinical trial site has appropriate conditions in place before the trial begins, including:

uAdequately trained and qualified personnel

uFully equipped and functional laboratory facilities

uSufficient number of eligible subjects

uResearch staff familiar with trial procedures and requirements

2. Ongoing Compliance Verification
Throughout all stages of the trial — pre-trial, during, and post-trial — our monitors ensure that investigators and institutions are adhering to:

uApplicable laws and regulations

uGCP guidelines

uThe approved clinical trial protocol

3. Informed Consent and Subject Management
We confirm that:

uAll subjects have signed informed consent forms prior to participation

uInclusion criteria are properly applied

uFollow-up visits, required tests, and examinations are completed as per protocol

uAny errors or omissions are corrected and documented accurately

uRevised informed consent forms are re-signed by affected subjects who are still participating in the trial

4. Data Accuracy and Integrity Assurance
Our team ensures that:

uCase Report Forms (CRFs) are correctly completed and consistent with source documents

uCorrections and notes are clearly marked, signed, and dated by the investigator

uPatient demographics, disease types, case numbers, and treatment outcomes are verified and recorded

5. Subject Withdrawal and Non-Compliance Documentation
We document instances where subjects withdraw from the study or fail to comply with the informed consent, and discuss these cases with the investigators to understand the reasons and implications.

6. Adverse Event and Device Defect Tracking
We ensure that:

uAll adverse events, complications, and device malfunctions are recorded

uSerious adverse events and critical device defects are reported within the required timeframes

uAppropriate follow-up actions are taken and documented

7. Trial Device Management Oversight
We monitor the supply, use, maintenance, transportation, receipt, storage, distribution, handling, and return of investigational medical devices to ensure proper accountability and safety.

8. Equipment Maintenance and Calibration Checks
We oversee the regular maintenance and calibration of equipment used during the trial to ensure accuracy and reliability of collected data.

9. Document Version Control
We confirm that all investigators receive and use the latest versions of clinical trial-related documents, such as protocols, CRFs, and informed consent forms.

10. Detailed Monitoring Reports
After each monitoring visit, a comprehensive written report is submitted to the sponsor. This includes:

uMonitor’s name, date, time, and location of the visit

uSummary of activities performed

uIssues identified and corrective actions taken

uEvaluation of protocol adherence and overall trial progress

Why Choose EPINTEK for Monitoring Services?

EPINTEK's team combines deep regulatory knowledge with extensive clinical operations experience. We help sponsors reduce risk, improve trial efficiency, and ensure full compliance with international and national GCP standards. Whether you need full-service monitoring support, our tailored solutions help safeguard the integrity and success of your medical device clinical trials.

Let us help you maintain the highest level of quality and compliance throughout your clinical development journey.

For more information about our monitoring services or to request a customized service proposal, please contact us today.