Xcene Research is committed to ensuring the highest standards of data quality in clinical trials. We understand the pivotal role that accurate and timely data play in the success of clinical research. What sets us apart is our unwavering dedication to delivering exceptional quality to our sponsors while prioritizing the well-being of our study volunteers.
One of our top priorities is patient care and the valuable contributions of our study participants. We guarantee that the data collected during their involvement significantly advances medical research. Our commitment drives us to consistently provide top-tier data to our esteemed sponsors, which in the long run will translate into new drug development that would be beneficial to patient care.
To maintain these high standards, Xcene Research employs a robust set of Standard Operating Procedures (SOPs), templates, and forms. Our dedicated team includes qualified healthcare professionals, supported by Research Assistants known for their data entry expertise. We conduct routine study audits, covering essential tasks to ensure top-notch data quality. These include:
1. Thorough Source Document Analysis
We scrutinize completed source documents for accuracy, completeness, and legibility.
2. Data Validation
We cross-reference the data in source documents with the information entered into the Electronic Data Capture (EDC) system for precision.
3. Error Trend Identification
We keenly identify error trends, enabling us to implement improvements in source document flow, data collection processes, and site procedures.
4. Regulatory Binder Assessment
We conduct meticulous reviews of regulatory binders, ensuring meticulous organization, filing, delegation of authority, comprehensive documentation, and the completeness of training records, which help eliminate quality check queries throughout the duration of the trial.
Our adherence to these processes, coupled with compliance with FDA guidelines for research and good clinical practices, allows Xcene Research to continually evolve, improve, and provide unparalleled data quality to our clients.
Trust is a fundamental pillar of our organizational values at Xcene Research, and we demonstrate this trust through various key principles. These principles encompass punctual project execution, unwavering dedication to uncompromising quality, transparent reporting of project status, and optimal communication to align seamlessly with our client’s objectives. Our commitment to upholding the highest standards in clinical research is unwavering, and we set ourselves apart by consistently delivering outstanding results.
Our mission revolves around expediting access to life-saving treatments in Africa. We imbue every project with a strong sense of care, ensuring that the data we generate is of the utmost quality. To achieve this, we conduct routine study audits that involve critical tasks such as rigorous protocol reviews, comprehensive source document assessments, identification of error trends, meticulous cross-referencing of data, and thorough reviews of regulatory binders. Through these rigorous practices, we guarantee that our sponsors receive data that is not only exceptional but also adheres to the highest industry standards.
