Data Management Services

At mediSMART, our data management services ensure accuracy, integrity, and regulatory compliance throughout the clinical data lifecycle. We apply robust planning, expert analysis, and validated systems to transform raw data into reliable insights that drive confident decision-making.

Our Data Management Services include:

💻 EDC Preparation and Guidelines

We manage the setup of Electronic Data Capture (EDC) systems, including guideline creation, user access configuration, and system validation — ensuring clean and timely data collection from study start to close-out.

📊 Design of Statistical Considerations

Our statisticians work closely with clinical teams to define key statistical parameters and endpoints, aligned with regulatory expectations and study objectives.

🔢 Sample Size Calculation

We provide precise sample size estimations based on the study design, expected treatment effect, variability, and power — helping sponsors optimize trial efficiency and statistical validity.

📝 Data Management Plan (DMP) Preparation

We develop comprehensive Data Management Plans, outlining all processes related to data handling, quality control, and timelines — ensuring smooth and consistent data operations.

✅ Data Validation Plan (DVP) Preparation

Our team creates Data Validation Plans to define edit checks, query logic, and data discrepancy processes — essential for data accuracy and regulatory readiness.

📈 Statistical Analysis Plan (SAP) Development

We prepare detailed Statistical Analysis Plans covering analysis populations, methods, and output specifications, ensuring alignment with the protocol and regulatory requirements.

🗄️ Database Generation and Data Entry Processes

We oversee custom database creation and data entry workflows, ensuring accuracy, traceability, and compatibility with regulatory standards.

📉 Statistical Analysis

Our expert statisticians perform in-depth statistical analyses using validated software and methodologies, delivering clear outputs for reporting and decision-making.

🎓 Data Management Trainings

We offer targeted training programs on data management systems, standards, and SOPs — empowering teams to maintain high-quality data throughout the study.