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QSS helps companies manage the operational, compliance, and data demands of running a clinical trial. If your trial is underway and you need structured oversight, site management, GCP monitoring, or data integrity support, we can help you keep it on track.
Running a clinical trial is an operational and regulatory challenge in equal measure. Investigators and site staff need to follow the approved protocol precisely. Data must be collected accurately, completely, and in real time. Adverse events must be identified, documented, and reported within required timeframes. And the entire process needs to be auditable at any point during the trial.
Good Clinical Practice (GCP) is the international standard that governs how trials are conducted, recorded, and reported. Compliance with GCP is not optional — it is the basis on which regulatory agencies evaluate whether the data from your trial is valid and whether your submission can be accepted. Gaps in monitoring, data management, or safety reporting during execution can undermine results that took years to generate.
QSS provides structured execution and data management support to help you maintain compliance, protect data integrity, and keep your trial moving through to completion.
We assess candidate investigational sites for infrastructure, patient population access, investigator experience, and compliance history, and support site initiation including training, document preparation, and readiness confirmation before enrolment begins.
We conduct on-site and remote monitoring visits to verify that your trial is being conducted in accordance with the approved protocol, GCP guidelines, and applicable regulatory requirements, flagging issues early before they affect data integrity.
We oversee data collection processes to ensure accuracy, completeness, and consistency throughout the trial, supporting the use of Electronic Data Capture (EDC) systems and reviewing data against source records to maintain a clean, audit-ready dataset.
We support the interpretation and analysis of trial data in alignment with the pre-specified statistical analysis plan, ensuring that outputs are accurate, reproducible, and ready to underpin your regulatory submission.
We support the identification, documentation, and reporting of adverse events and serious adverse events in compliance with regulatory requirements, ensuring that safety information reaches the appropriate parties within required timeframes.
We maintain the Trial Master File (TMF), the collection of essential documents that demonstrates the trial was conducted in accordance with GCP standards and is the primary evidence base for regulatory review and inspection.
We monitor for protocol deviations, support investigation and documentation of non-compliance when it occurs, and help your team implement corrective actions to prevent recurrence.
Explore articles, blogs, and videos on GCP compliance, clinical trial data management, and site monitoring.
Good Clinical Practice is an international standard for the design, conduct, recording, and reporting of clinical trials. It is required by the FDA, Health Canada, the EMA, and most major regulatory agencies worldwide. Compliance with GCP ensures that trial data is credible and that participant rights and safety are protected throughout the study.
Monitoring involves regular review of trial conduct at investigational sites, verifying that investigators are following the approved protocol, that informed consent procedures are correct, that data is being recorded accurately, and that any adverse events are being identified and reported appropriately. Monitoring can be conducted on-site or remotely depending on the trial design and regulatory expectations.
The Trial Master File is the collection of essential documents that demonstrates a clinical trial was planned, managed, and conducted in accordance with GCP. It is the primary evidence regulators and auditors review when assessing whether a trial was conducted properly. A complete, well-organized TMF is a non-negotiable requirement for any regulatory submission that relies on trial data.
Data management involves establishing robust collection processes, using validated Electronic Data Capture systems, reviewing data against source records, and maintaining clean, consistent datasets throughout the trial. Regulatory agencies expect data to be accurate, complete, and verifiable at any point during or after the trial. We oversee these processes and support your team in maintaining data integrity from first enrolment through to database lock.
Protocol deviations must be identified, documented, and assessed for their impact on participant safety and data integrity. Significant deviations may need to be reported to regulatory authorities or ethics committees. We support the investigation and documentation of deviations and help your team implement corrective actions to prevent recurrence.
Serious adverse events must be identified and documented at the site level and reported promptly to the sponsor, who then determines whether expedited reporting to the regulatory authority is required. Timelines and reporting requirements vary by jurisdiction. We support sponsors in meeting their safety reporting obligations under FDA, Health Canada, and international requirements.
Yes. Quality Smart Solutions can step into ongoing trials to provide monitoring support, data management oversight, or TMF remediation at any stage of execution. We assess your current situation and provide targeted support where it is needed most.
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