High-quality data is one of the most critical elements of all clinical trials. Thus, data management is a core service of Wizard and a critical element of our customer value proposition. Our Data Management team is headed by one of the leading experts in the field of Data Management.
Wizard is a knowledge-based full service CRO catering to the domain-intensive nature of ‘Clinical’ data management. Poor quality data can not only be detrimental to the regulatory acceptance of a molecule, but also delay the market launch. As a result, biopharmaceutical companies recognize the value of high quality data, delivered in a cost efficient manner. We are a partner of choice for top pharmaceutical, biotech and FMCG companies for years. Our decades of experience has resulted in vast exposure ranging from project based delivery to strategic services globally as well as regionally. We have one of the biggest strategic partnership with a global pharmaceutical company; managing several programs with consistency across cluster of studies & contributing to client’s systems and processes.
Wizard has successfully managed studies across Phase I, II, III and IV studies for various regulatory submissions like USFDA, DCGI, EMA, and MHRA. Clinical research being our core expertise, you will find a significant difference in your outsourcing experience with us. See how our teams can help you with rescue studies, hybrid (paper + EDC) studies, data migration and other niche services.Our Comprehensive Global Clinical Data Management Services that combine our expertise with the latest technology, tools in EDC systems and data integration.
- e-CRF and Paper CRF Design and Production
- Electronic and facsimile data capture
- Database Design and Validation
- Interactive drug management and drug supply
- Laboratory data management (Lab, ECG, PK)
- Radiology Images Management
- CRF/Edit Check Log and Tracking
- Query Management, Query Generation and Resolution
- Adverse Event and Concomitant management.
- Safety procedures AEs/SAEs Reconciliation, reporting and management of protocol violations, deviations, and endpoints
- Medical coding using standard dictionaries; MedDRA, WHO-DD, and sponsors dictionaries
- Data validation, review, and cleaning
- Quality Control to highest standards, with Quality Control Management processes and ensure high-quality data
- Management of data of third party vendors, data consolidation and conversion
- Submission and transfer of Data to Sponsor, Regulatory Agency using CDISC standards
- DsNavigator / ARISg
- Cognos and Crystal Reports
- Clinical Trial Management Systems (CTMS)
- Statistical expertise in study design and Statistical Analysis Plan