Data Management and Biostatistics
From clinical development planning to data delivery, NEOX is committed to customizing data management solutions that emphasize accuracy, integrity, accountability and transparency as much as agile reporting. Our expertise, supported by validated, regulatory-compliant and quality-controlled data management architecture, enables us to produce results that are reproducible, source-verified, delivered on time and cost-efficient.
NEOX has extensive experience in clinical monitoring and data management activities using several industry standard EDC systems including Oracle Clinical and InForm, Medidata Rave, eCaseLink and OpenClinica. We work closely with our clients to utilize any system that the sponsor requires. We are also able to skillfully import, connect, and clean Real World Data/Real World Evidence (RWD/RWE) from disparate sources.
NEOX data management services can be utilized in both drug and medical device development for clinical trials and registry studies of various size and complexity, across a broad range of indications.
Our Clients Can Expect
- Customized, validated and cost-effective solutions
- Consistency of clinical data management ensured by global standards
- Quality management of data reliability, accuracy, integrity and accountability
- Databases residing in safety on our own private physical servers located in secured ISO certified environment (no shared or cloud solution used)
- Early problem-solving and reduced oversight time ensured by our agile project management
- Flexibility to meet sponsor´s needs throughout whole project life cycle
Key Data management Features:
- Expert ePRO/eCRF and database design enhanced by streamlined randomization, online queries generation and resolution, or automatized pharmacovigilance alert messaging
- RWD/RWE capture/import, optimization, connection and cleaning
- Utilization of privately hosted, 21 CFR Part 11 compliant open source EDC or any other EDC of choice
- Readiness to develop unique study-specific modules by our in-house programmers
- Collaborative web-based platform at our disposal with access to Interactive Web Response System (IWRS), Clinical Trial Management (CTMS) and Training Systems
- Source data verification and medical coding
NEOX offers biostatistics solutions throughout the trial process. We approach each project from our deep expertise in therapeutic indication and compounds or medical device.
- Clinical development planning
- Biostatistical inputs during protocol designing, analysis and endpoint strategies
- Power analysis and sample size determination
- Randomization method selection, schedule creation and integration with EDC/Randomization system
- Statistical Analysis Plan (SAP)
- Frequent, automated reporting of results
- Data Validation Reports (DVR) for completeness and correctness of clinical data
- GCP and ICH E9 compliant interim and final statistical analysis
- Data delivery in Clinical Data Interchange Standards Consortium (CDISC) format
- Collaboration with medical writers to assure appropriate interpretation of results
- Selection/development of appropriate methods for RWD/RWE analysis
- RWD/RWE analysis