Data Management and Biostatistics

Data management

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. We take pride in producing 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 EDC systems, including Oracle Health Sciences InForm, Oracle Clinical, Medidata Rave, eCaseLink and OpenClinica. However, we are flexible in using any system that the sponsor requires.

Moreover, our collaborative web based platform gives a secure access to Interactive Web Response (IWRS), Clinical Trail Management (CTMS) and Training/Learning Systems. All parts of our architecture support regulatory compliance, quality control and complex data management.

NEOX data management services can be utilized in 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 and cost-effective solutions.
• Consistency of clinical data management ensured by global standards.
• Quality management of data reliability, accuracy, integrity and accountability.
• Expert eCRF and database design which promotes data collection of clean data.
• Our data management experience means that EDC system can be in place in as few as 2–8 weeks.
• Early problem solving and reduced oversight time ensured by our agile project management. We offer flexibility to meet partner´s needs throughout whole project life cycle.

Biostatistics

NEOX offers biostatistics solutions covering the wide spectrum. We bring a profound understanding of the background of disease and compounds or devices.

Our services:

• 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 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.