| Seasoned Know-how |
XTrials Research Clinical Data Services leverage our strict quality standards, operating procedures, and innovative
Internet technologies, to deliver high quality clinical databases in the fastest possible time.
Our dedicated CDM Project Teams work closely with sponsors through all phases of database specification development
and endeavor to function as an extension of your in-house resources. We believe close communication and collaboration,
particularly at the early definition stages, promote firm, hands-on, assurances that your protocol requirements are
being met in ways that facilitate accurate, consistent, and complete, clinical deployments.
Quality process controls are built into every step of our data management procedures. We know from first-hand experience,
these are the principal drivers for delivering clean databases that reduce overall cycle times. But unless these quality
methods are closely integrated with robust, enabling technologies, their full business impact and potential are not easily
realized. Our unique blend of expert clinical knowledge, process engineering, and Internet-based solutions, provides you
with the reliable data services you need to efficiently clean and lock your databases with optimal speed and integrity.
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Comprehensive Clinical Data Management Services
- Data management and regulatory standards consultancy
- Data management plan, validation conventions, data handling guidelines
- Case report form design, production, and distribution
- CRF annotation and data transfer schema (CDASH, STDM)
- CRF completion guidelines and site training
- Monitors presentation and training
- Database design, construction, and qualification
- CRF logging, tracking and pre-entry review
- CRF imaging and indexing
- Hybrid data capture including double data entry and verification
- Data field and cross-form edit checking
- Central laboratory, imaging, ECG, and PRO feed integration
- Secondary data review and quality assurance
- Automated and manual query management
- Protocol violation tracking & reporting
- AE, CM and disease preferred term encoding (MedDRA, WHOdrug)
- SAE reconciliation
- Data evaluability and validation meeting
- Database freeze, lock and audit
- Integrated safety/efficacy summaries (ISS & ISE) support
- Archiving and imaging
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| Proven Results |
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