Landmark CRO provides end-to-end clinical data management services, from data collection and validation to analysis and reporting. Landmark CRO uses advanced technology and software to ensure the accuracy, completeness, and consistency of clinical data, as well as compliance with data standards and regulations. Landmark CRO also offers data integration, data visualization, and data analytics services, to support decision making and knowledge generation.
Data Collection & Management
Data Cleaning & Validation
Data Integration & Analysis
Additional Services for a Successful Trial
Choosing Landmark Research CRO as Your Trusted Medical Device CDM Partner
Data Collection & Management
- CRF/eCRF Design : Our experts design Case Report Forms (CRFs) or electronic CRFs (eCRFs) compliant with CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) for efficient data capture
- SDTM Programming : We configure the database to follow the SDTM (Standard for Data Transfer Model) for consistent data structure and analysis across studies
Data Cleaning & Validation
- Data Entry & Verification : Our data management specialists manage the data entry processes, ensuring accuracy through double-data entry or electronic validation checks.
- Query Management : We generate comprehensive data queries (DQs) are generated for investigators to clarify inconsistencies and ensure data completeness
- Medical Coding : Our team assigns standardized medical codes (e.g., MedDRA) for the diagnoses and procedures for data analysis, facilitating regulatory reporting
Data Integration & Analysis
- Electronic Data Integration : We integrate data from various sources (e.g., ePRO – electronic Patient Reported Outcomes, wearable sensors) into the central database
- Real-World Data Management : CROs can handle real-world data (RWD) from registries or electronic health records (EHRs) for broader study insights
- Statistical Listings Development : They develop statistical listings in formats like R or SAS for statistical analysis
Additional Services for a Successful Trial
- Collaborative Data Management Plan : We work closely with you to develop a comprehensive data management plan outlining data collection, storage, and security protocols, ensuring regulatory compliance
- Real-Time Data Visibility : Landmark Research CRO offers real-time data dashboards upon request, allowing you to track study progress, identify potential issues early on, and make informed decisions
- Database Lock & Secure Decommissioning : Once data collection is complete, we ensure proper database lock (freeze) to preserve data integrity. After study completion, our team oversees secure database decommissioning following regulatory guidelines
Choosing Landmark Research CRO as Your Trusted Medical Device CDM Partner
- Proven Track Record : We have a well-established reputation for delivering high-quality CDM services in numerous successful medical device trials
- Advanced Technology Infrastructure : Our commitment to cutting-edge technology ensures seamless data management for your device trial
- Regulatory Compliance : We maintain a thorough understanding of relevant regulatory guidelines for medical device trials, guaranteeing compliance throughout the process
Benefits of using a CRO for Medical Device CDM
- Unmatched Expertise : Our team has extensive experience handling medical device trials, ensuring a deep understanding of specific data collection and management challenges
- Focus on Standardization : We prioritize CDISC/CDASH adherence for consistent data structures, leading to simplified analysis and robust results
- Advanced Technology : We leverage state-of-the-art data management systems and electronic platforms to ensure data security, efficiency, and scalability
At Landmark Research CRO, we are committed to providing exceptional Clinical Data Management services that empower your medical device trial to achieve its full potential. Contact us today to discuss how our expertise can transform your next medical device development program