We offer full data management & statistics operational support, specifically for clinical trials – from protocol development, data collection and analyses right through study results reporting.
Close collaboration of our data management and biostatistics teams guarantees the timely delivery of accurate, high-quality study results.
We help define the questions and how to answer them
We pre-plan analyses to answer protocol objectives (SAP)
We ensure that all protocol key data are collected in CRF
We deliver accurate, complete and reliable data (DMP, DVP, Reconciliations)
We program the datasets according to CDISC standards (SDTM and ADaM)
We deliver the TFLs according to SAP and QC, plan and review the CSR statistical interpretation
Data Management & Biostatistics
Our data management services cover the data life cycle, from collection to archival, using regulatory-compliant tools to ensure data integrity and industry standards. Our experienced, agile and cohesive team of clinical data managers ensure a seamless flow from first-patient-in to database lock.
We provide comprehensive end-to-end data management services, including (e)CRF development, database design, electronic data capture, data cleaning, as well as query resolution, medical coding, data review meeting organisation, database lock, and archival, ensuring that the necessary documentation is provided at each step.
By offering tailored solutions with a strong focus on quality, our clients can stick to timelines and keep costs to a minimum. Our statisticians provide statistical support along the full development cycle of the drug, from early development to post-marketing studies, across a wide variety of therapeutic areas.
We provide clinical study design and protocol support, regulatory support, statistical part of protocol writing, statistical analysis plan (SAP) writing, programming, tables figures and listings (TFL) deliverables, statistical and clinical study reports support.
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