At a glance - CanBiotech
Transcription
At a glance - CanBiotech
Capish Solutions provides tools which will help life science and health care companies to make better sense of the ever increasing data volumes. Bring your data to life Data Generation Data Entry At a glance Capish Solutions gives you the tools to: • • • • • • Achieve a deeper understanding of your data through superior data analytics tools. Data Export CDISC Standardisation Capish Ontology DATA Identify relevant information using Capish’s data mining and search capabilities. Collaborate with your partners through Capish’s web based cloud ready service. Archive data using XML as a flat non-proprietary text based file format. Interactively explore and compare all available data and drill down from summary visualizations to individual patient records. Analysis Tools (Free-text Search, Charts, Data Exploration) INFORMATION Company and Collaboration Partner Users KNOWLEDGE Completed studies Clinical trial Management (CTMS) Data Management ODBC/ASCII SDTM Capito Capish Holons Capish Infomart Capito Capish Holons Capish browser Gain unprecedented access to every single data point through interactive navigation and drill down functionality. Consolidate data and information from different service providers and disparate data sources into one unified knowledge base. Integration layer Capish Data Exploitation Platform Ongoing studies Clinical trial Management (CTMS) Data Management ODBC/ASCII ASCII Capito Capito Capish Holons Capish Holons Transfer at predetermined intervals Automated Feedback to CRO Patient Centric Holons Capish Indexing Management Regulatory Affairs Clniical Operations ASCII (for import in 3rd party software) Proprietary tables (ADaM, SDTM+,etc) Pharmacovigilance Statisticians Automated feedback to Company Capish Solutions is built on an Ontology - a framework with known relationships between individual entities within the framework. This structure provides the backbone for a highly structured and consistent approach to information management and allows data pooling across disparate data sources and different clinical trials. Filter data according to your needs and maintain the applied filter across all graphs. Capish Solutions provides free text search and data mining capabilities to evaluate hypothesis easily. Collaboration platform Capish Solutions provides a collaboration platform for companies, divisions and CROs to work together in a seamless manner. Capish Solutions enables a structured consistent approach to data visualization and management across organizational and geographic boundaries through the consolidation and integration of data from disparate sources in a single unified knowledge base. Clinical Trial Design and Conduct Capish Solutions can help in the design of new clinical trials on the basis of sound systematic analysis of patient populations in the same therapeutic area. Capish Solutions can help to evaluate and validate biomarkers for improved efficacy and safety analysis as well as patient stratification. Capish Solutions offers the tools to conduct interim analyses in the context of adaptive trials. Clinical Safety Review Regulatory Submissions Pharmacovigilance Capish Solutions enables the identification of unexpected trends and unknown relationships through the ability to interactively explore and compare all available data without the need for time consuming data extraction and manipulation. The unprecedented search, filtering and drill down functionalities facilitate the medical review of the available clinical data. Capish Solutions accelerates the analysis and extraction of information relevant for the regulatory file. Capish Solutions accelerates the evaluation and answering of queries by regulatory authorities. Due to its flat XML file format Capish Solutions has the potential to become a data standard for the eCTD. Capish Solutions can help to quickly detect safety signals and discover product-AE relationships across all relevant data sources. Capish Solutions expedites the assessment of the risk-benefit ratio of a product and aids in the preparation of safety reviews. Capish Solutions The Challenge The pharmaceutical industry is facing many challenges from spiraling R&D costs to a new therapeutic landscape of servicing true unmet medical need and the advent of personalized medicine. Undaunted, the industry is looking at many ways to address these challenges from the virtualization of the R&D process and the development of strategic alliances to getting a better understanding of disease parameters. Converting Information into Knowledge The Solution Capish Solutions is a knowledge management tool providing the missing link for R&D leaders in their aim to transform the drug development process: • Consolidate information in a consistent manner across different organizations and data sources. • Bridge the gap between disconnected data stores to advance and accelerate innovation in the development process • Utilise leading edge knowledge management and data visualization methods to enhance the efficiency and effectiveness of modern R&D practices • Introduce new data management approaches that enable drug developers to quickly gain an optimal insight into clinical R&D programmes. Corporate Head Office Capish International AB Stortorget 9 211 22 Malmö Sweden +46 (0)40 10 88 80 USA Capish Inc. 3711 Market St 8th floor Philadelphia PA 19104 +1 (484) 436 4398 capishknowledge.com [email protected]