Our highly experienced statistical team have been advising clients on whole clinical development programmes in the CNS area for many years.
NeuroScios is a specialist provider of Statistical and Data Management services for clients developing treatments for neurodegenerative diseases such as Alzheimer's, Mild Cognitive Impairment, Parkinson’s and Stroke and psychiatric diseases such as Schizophrenia and Depression.
NeuroScios has developed an extensive range of data collection tools available to clients (from EDC, digital pen, tablet/iPad to ePRO with smartphone and even voice recognition). These collection tools are all supported by a single sophisticated, but user-friendly, Clinical Data Management System CDMS (dataKapture.com) which is accessible to all designated end users.
Together with its parteners NeuroScios offers an extensive library of key psychometric computer based tests (covering the primary cognitive domains of Attention, Episodic Memory, Working Memory and Psychomotor Speed). An extensive library of ‘digitised’ pen and paper based test forms (both Clinical/Psychometric) covering a wide range of languages is also available. Again all these are combined into a single unified DMS system.
Data Management
Our data management team is led by a number of highly-experienced and technical project managers who are responsible for the quality and successful delivery of all data management tasks and deliverables. They use 'state-of-the- art' data management support tools as part of our 'in-house' CDMS system. We can also enable secure, remote access and usage through our cloud based setup.
Our Data Management services include: CRF design, EDC data review, Manual 'double key' data entry (with query generation, resolution, reporting and full audit trail), Data importing to SAS for derivation and structuring prior to analysis, Data coding with (WHO/MedDRA dictionaries) as well as Quality control.
Our industry-leading Clinical Data Management System (CDMS), dataKaptureTM is built on the latest industry standard Microsoft platforms (.Net, HTML5, Silverlight and SQL) and is integrated with SAS software. The CDMS is fully validated, documented and compliant with CFR 21 part 11.
The platform provides clients direct access to real-time data reporting, with interactive graphical review, patient profiling and trend assessment. It is a fully-enabled system that is suitable for data collection using both electronic (EDC, digital pen. tablet/iPad, ePRO and IVRS) as well as manual (traditional paper) CRF books.
Our team has experience across all phases of clinical development and most therapeutic areas, which provide familiarity with all sorts of databases and CDISC SDTM and ADaM structures. We have particular expertise with databases from PK/PD investigations, health economics, hospital registries and post-marketing safety monitoring trials. However, underlying this breadth of experience is our core focus and primary interest which remains neuro-cognition.
Statistical Services
Our highly experienced statistical team has been advising clients on whole clinical development programmes in the CNS area for many years. We can help with ‘Proof of concept’, Dose ranging or even with Adaptive designs and Interim analysis aspects during the phase II 'learning' process as well as consultation on designs for 'confirmatory' phase III programmes.
Our statistical services include: Protocol design, Sample size investigations, Development of statistical analysis plans and table shells, Application of analytical methods and Production of stand-alone statistical reports or consolidated Clinical Study Reports.
We routinely integrate databases from multiple projects, undertake meta analyses and create Integrated Safety Summaries. We are also regularly involved with DSMB's providing Data Reviews and Interim Analyses. We provide expert reports and 'state of the art' publication and presentation services.
Our particular strengths are: Adaptive designs:, Repeated measures mixed model analyses of time series data, Non-linear mixed modelling analyses of sparse data, Meta-analyses (Fixed and Random effects) for the combination of treatment estimates from individual trials and Survival analyses.