Statistics & Data Management

Data Management

The key to excellent data management is flexibility. We respond smartly and straight forward to minimize any influence on timelines. This ability is the true mark of a valuable CRO partner —but NUVISAN surpasses that basic function by applying strong cost-effective measures, quality assurances, as well as therapeutic and regulatory expertise.

Since the data of any clinical investigation is of utmost value NUVISAN’s philosophy is not to separate data management from the study team, but involve the data management department already in the proposal process. We believe integration from the start is the ideal way to efficiently clean and organize data.

You can work with us for full-trial build or select from our suite of Data Management Services:

• CDASH Case report form (CRF) design, electronic or paper
• Data Mangement Plan and Data Validation Plan Development
• Database set-up and validation
• Electronic data capture (EDC) systems implementation and training
• Double data entry for paper CRF–based studies
• In-depth, thorough quality assessments: checking for errors or trends and querying data through final database lock
• Generation and Delivery of CDISC SDTM submission package

Validation of all system components throughout the study period is performed as modifications are introduced

We also adhere to the benchmarks set by SCDM and CDISC.

Use of familiar systems improves efficiency because it frees sites to focus on the protocol requirements rather than technology. We work with ORACLE’S INFORM, Oracle’s CLINTRIAL and CLINSPARK to afford industry recognized programs in the performance of data management activities.

Statistics

Integration and collaboration are the foundations of our superior statistical services. Having a group of experienced statisticians and statistical programmers working together with the data management team, and being therefore fully engaged throughout a study, leads to a fruitful cooperation for each individual trial.

Biostatistics is involved in study planning and data quality checks, performs programming of analysis data sets as well as tables, listings and figures for study reports, and collaborates with our medical writers and medical experts to produce the clinical study report. This alignment is clearly defined and has shown proven efficiency throughout the conduct of numerous studies.

Our full-range of statistical services includes:

• Consultancy during protocol development; from study design, sample size estimation and methodology review, to full engagement in clinical study reports
• Regulatory consulting
• Randomization
• Statistical analysis plan development
• Table shells - so you know how your data will be presented
• SAS®-programming of analysis datasets as well as tables, listings and figures
• Rapid reporting
• Full suite of CDISC SDTM and ADaM data formats and accompanying files