At CodeStat Solutions, we are dedicated to supporting your company every step of the way, from the initial design of the clinical trial to study close-out. Our experienced team of experts is well-versed in regulatory guidelines from FDA, EMA, 21 CFR Part 11, and ICH-GCP, ensuring that your data management processes adhere to industry standards.

Our knowledgeable data managers specialize in delivering timely results for your clinical trial data, prioritizing accuracy and integrity without compromising on turnaround times. We understand the importance of meeting critical deadlines, and we pride ourselves on consistently delivering high-quality results within stipulated timelines.

From clinical development planning to data delivery, CodeStat Solutions offers customized data management solutions that prioritize accuracy, integrity, accountability, and transparency. Our services encompass a comprehensive range of activities, including (e)CRF design and preparation of annotated CRF, database design, clinical data entry, laboratory data handling, medical/dictionary coding, data validation, query management, and adherence to current data standards such as SDTM, CDASH, and other CDISC standards.

Additionally, our quality control processes and database lock procedures ensure that your data is of the highest quality and integrity before dissemination. We conduct (blinded) data reviews, perform SAE reconciliations, set up status reports and statistics, and prepare statistical or integrated reports to provide you with actionable insights derived from your data.

Furthermore, our expertise extends to third-party vendor management, ensuring seamless coordination and collaboration across all aspects of data management.

Partner with CodeStat Solutions for agile reporting, reproducible results, source-verified data, timely delivery, and cost-efficient solutions. Let us guide your company through the complexities of data management with our expertise and commitment to excellence. CodeStat Solutions – where accuracy meets efficiency in clinical data management.