The impact of ICH E6 has been to focus attention on the identification and mitigation of risk within clinical trials. At Clintec, utilizing such a a risk-based approach has always been essential to optimize quality in our clinical service delivery. Early identification means any issues are resolved and therefore adverse regulatory findings can be avoided. This approach also means investigator sites are inspection-ready throughout the life of the clinical trial.
Global and local expertise
Our Quality Control (QC) expertise spans the spectrum of therapeutic indications in both complex, global clinical trials as well as those more regionally focused projects and we offer both on-site and remote QC site checks.
Impact of increased expectations of site performance and support we provide
- Site staff must be well trained and up-to-date in Good Clinical Practice with respect to the design, conduct, and reporting of clinical trials
- Site staff should be trained on the impact of risk-based or targeted monitoring, where applicable, as first line responsibility for quality reporting remains at site level
- Investigator accountability for supervision of all staff and vendors also requires the provision of support and training
- Electronic Case Report Forms (eCRFs) require to be within one week of patient visit
- Source notes need to follow ALCOAC* (Attributable, Legible, Contemporaneous, Original, Accurate and Complete) principles
- All queries require to be resolved in real time
Re-education and enhanced capabilities required of investigational site
- Sites requite to have established robust processes including documentation n Standard Operating Procedures (SOP)
- Documented training on processes are required to be maintained
- Self-regulation and evidence of adequate QC process is essential
Clintec’s experienced Clinical Research Associates (CRAs) have extensive Quality Control experience, and cover many geographies and are able perform specialist sire QC visits. As ‘locals’, they are either native or fluent in local language language speakers and their extensive local knowledge makes them ideally placed to advise and support sites. Prior to the visit CRAs review all available documentation, including any available Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) systems, as well as any outstanding site issues. All activities are conducted in accordance with client &/or project specific QC documents and checklists. In addition, QC visits are conducted without the regular CRA in attendance to guarantee an independent review of the site and of CRA performance.
During each visit, any urgent concerns identified are escalated immediately. Findings are documented within the Quality Control Report and reviewed with the clinical trial team, so that remediation steps can be taken. After each visit, reports are submitted to our clients within defined timelines.
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