Clinical Data Management (CDM)
Our Unmatched Expertise in Accelerating Clinical Trials.
YouV is highly experienced in data management and database programming teams take pride in recommending efficient data management and programming solutions for your study.
We are here to enhance the speed of trail through reliable and secure data processes using the industry-leading technology for data capture. All databases are subject to the highest data quality standards and will pass a database audit.
We are here to enhance the speed of trail through reliable and secure data processes using the industry-leading technology for data capture. All databases are subject to the highest data quality standards and will pass a database audit.
A comprehensive set of Professional CDM Services that focus on your trial success.
We are certified and have unparalleled expertise in Medidata RAVE, INFORM and IBM Clinical Development Study Builders.
Data Management Plan (DMP) development
Medical data coding
CRF/eCRF design and development
Query Management
CRF Annotation & Review
Safety Data Management & Reconciliation
Data import and data export specification preparation
Data processing for paper and EDC studies
Database Build & Design
Data Export/Transfer
Data validation specifications
Data standardization/CDASH Compliant deliverables
Edit checks Programming & Testing
Data management, Project management, study oversight, and consulting support
Our Approach.
Our standardized data management approaches bring about efficiencies that save time and cost, create trustworthy data sets, and are flexible enough to be tailored to each study.
Data Management Planning.
- Devlopment of detailed data management plan that outlines the processes and procedures for collecting, storing, and managing data from a clinical trial.
- Studies designed and implemented using industry-standard CDISC SDTM and ADaM guidelines.
- Help in selection of appropriate data management systems.
Data Entry & Validation.
- Rapid Data Entry and Validation services ensuring the data accuracy and entry to EDC systems in timely manner.
- Quality control check gates using edit checks and data validation checks that are set to automatically check the data for errors, inconsistencies, or missing information.
- Medical coding using WHODrug & MedDRA dictionaries.
- Well-defined and robust processes to ensure that the data caputred is accurate and complete, and that it meets the requirements of regulatory authorities.
Data Cleaning & Reconciliation.
- Rapid query identification and resolution to resolve any data discrepancies or errors observed during study conduct.
- Data cleaning and reconciliation services to ensure that data is accurate, complete, and consistent, and that it meets the requirements of the regulatory authorities.
- Real-time data access and Regular Study Updates to clients for better study management.
- Serious adverse event (SAE) reconciliation. Management and integration of local laboratory reference ranges with CRF data.
- Integration, verification and reconciliation of external electronic data.
Data Reporting & Analysis .
- Data reporting and analysis services that help the client to understand the results real time
- Real time Study-specific data listings, tables, figures and statistical analysis services to help our clients make informed decisions about their trial
Data Archiving & Retrieval.
- Safe and easy data archiving and retrieval services for future use of Study data .
- Methods Meets the requirements of the regulatory authorities.
Clinical Data Management Services in Nutshell:
At YouV, we understand the importance of thorough preparation and planning in the study startup phase. Our clinical data management team works closely with you to ensure that all necessary considerations for data collection and management are taken into account, and that your study is set up for success.
- Develop and implement data management plans.
- Perform database design and build activities.
- Provide training to study staff on data management processes and systems.
- Conduct data quality control and data validation activities.
- Develop data reconciliation plans and data transfer agreements.
At YouV, we understand the importance of efficient and effective data management during the conduct of your clinical research study. Our clinical data management team works closely with you and your study sites to ensure that all data collection and management activities are conducted smoothly and efficiently.
- Manage data collection, entry, and validation.
- Conduct ongoing data quality control and data cleaning activities.
- Provide data query resolution support.
- Monitor study progress and data completeness.
- Ensure timely and accurate data transfer to sponsor.
- Provide regular data reports and dashboards to study team.
- Coordinate with study sites to resolve data-related issues.
At YouV, we understand the importance of comprehensive support during the closeout and post-closeout phases of your clinical research study. Our clinical data management team works closely with you to ensure that all necessary activities for study closeout and data archiving are performed efficiently and effectively.
- Conduct final data cleaning and data quality control activities.
- Prepare study database for archiving and maintenance.
- Provide final study datasets and analysis datasets.
- Generate final study reports and submit to sponsor.
- Assist with publication and presentation of results (if required)
- Maintain study data and archives for long-term accessibility.
- Provide ongoing support for regulatory submissions and interactions with regulatory agencies.
Case Studies.
Adding value to your businesses through our services
Other Expertise.
Regulatory Support Services
Project Operations
Biostatistics
Pharmacovigilance
