Clinical Data Management Service is the first most import part of product life cycle. CDM services at AstraClinical covers the process of collecting, validating, and preparing the data towards statistical analysis for clinical trials. This starts with setting up a clinical data collection tool(s) or a clinical database based on study protocol to collect and store data. Once data is stored, implementing data validation steps is crucial to ensure accurate data is collected and complies with ICH-GCP and all applicable global and local regulatory requirements. Once the data collected is fit for analysis, the database is locked to avoid any modification and datasets are delivered to statistics and programming teams for analysis.

AstraClinical is providing Clinical Data Management services in a wide range of study designs and methods. We provide services from the design of the Protocol, Informed Consent Form, Case Report Form, database build, testing and validation, data entry, coding and Serious Adverse Event (SAE) management, to delivery of complete and accurate data in a customized output format.

AstraClinical expert Clinical Data Management team offers tailored concepts across all key therapeutic areas with particular expertise not only in pivotal Phase II/III trials, but also for late-phase approaches. We combine experience with technology and therapeutic expertise to ensure actionable outcomes and highest quality and process acceptance in terms of the data we deliver.

As a customer-focused operation, we feature a robust service portfolio and deliver the highest quality results on every project. That’s why we have embedded quality checkpoints into our processes from beginning to end.  We use multiple industry-leading electronic data capture (EDC) technologies suited to your requirements and adapted to a decentralized/virtual trial approach.

Our Clinical Data Management Services include:

• Data Management Plan
• Project Management
• Protocol review
• CRF/eCRF design and development
• CRF Annotation, Testing & Validation
• Database design, build and test
• Data validation and Query management
• Edit checks Programming & Testing
• Data entry/reviews/cleaning
• Medical coding (MedDRA, WHODrug)
• Safety Data Management & Reconciliation
• Data Integration services for due diligence
• Database exports/transfers
• Database lock and audit
• Flexible reporting solutions
• Database release using sponsor format (SAS, CDISC (SDTM, define.xml), etc)
• Real-time data viewing and reporting

Clinical Data Management, Project Management, Clinical Monitoring and Medical Management are part of clinical operations. AstraClinical takes care complete clinical operations with dedicated experts and physicians.