Download - Clinical cube customer presentation30 04 14
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Customer Briefing
30th April 2014
Peter Watts
THIS DOCUMENT AND THE INFORMATION AND DATA IN IT ARE PRIVILEDGED AND CONFIDENTIAL. THEY ARE PROVIDED IN CONFIDENCE, FOR THE SOLE PURPOSE OF EVALUATING THE CLINICAL CUBE OFFER AND MAY NOT BE DISCLOSED TO ANY THIRD PARTY OR USED FOR ANY OTHER PURPOSE WITHOUT THE EXPRESS WRITTEN PERMISSION OF THE CEO OF CLINICAL CUBE LIMITED.
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Clinical Cube deploys data and technology that expedites and transforms the five stages of clinical trials and related drug development processes. Our solu;on allows us to process and dis;ll massive amounts of standard and non-‐standard observa;onal and clinical data.
Proprietary data extrac;on capabili;es allow us to turn data into knowledge, deliver focused reports and run unique pa;ent recruitment and monitoring processes on behalf of our clients.
Proposi;on
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Current prac;ce
Random
Clinical Cube
Precise
• Clinical Cube replaces current fragmented & inefficient processes with an ultra efficient data & technology solu;on
• Our managed service provides immediacy and accuracy, removing the arbitrary nature of manual legacy clinical data collec;on solu;ons
Unique Proposi;on
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• CC//DATA is the central data warehouse that drives all of Clinical Cube’s individual product solu;ons.
• Real world health and demographic data combines with primary and secondary care health data sources to build the core of Clinical Cube’s analy;cal services
CC//DATA
CC//DATA
CC// Feasibility
CC//RECRUITMENT
CC// REPORTER Clinical Cube
Product portfolio
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All repor;ng and analysis is developed in collabora;on with our customers and the outputs are unique in regard to their specific needs. Typically these reports include the following:
Report and analysis
• Prevalence by geography -‐ produced na;onally, regionally and by surgery. • Prevalence by hospital – surgeries linked to hospital by radius • Disease incidence by hospital • Loca;on – geographical analysis of trials by loca;on showing phase of trial, therapeu;c area, recruitment target and recruitment status
Feasibility
• Na;onal prevalence review and locality hotspot iden;fica;on • Aggregated (non PCD) subject data extracted from GP systems* • Individual subject data (PCD) extracted from GP systems *
Recruitment
• Aggregated (non PCD) subject data extracted from GP systems, weekly, monthly quarterly * • Individual subject data (PCD) extracted from GP systems * • Safety and surveillance reports * • Excep;on and adverse events repor;ng * • Quality of life reports *
Reporter
• Clinical Cube, under IGSoC governance standards, will support appropriation of data extraction agreements with GP’s, Investigators and patients
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• The impera;ve to be agile and accurate in delivering trial feasibility, at all phases of development, has never been greater. Speed and precision, combined, offer the key to expedi;ng drug development ;mescales and improving related ROI.
• CC//Feasibility is used to address feasibility analysis at the outset of trial development, Phase 0, and throughout phases II, III and IV of the trial development process.
• Combining UK observa;onal health data with other related informa;on sets allows our systems and analysts to work hand-‐in-‐hand with our customers to be_er inform and accelerate the feasibility and assessment stages of all phases of the drug development process.
CC/FEASIBILITY
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CC/FEASIBILITY • CC/Feasibility uses the latest Geo-‐mapping tools to iden;fy pa;ent cohorts
across the country using the trial protocol to define the search algorithm
• Once na;onal pa_erns have been iden;fied data can be interrogated at a local surgery surgery level
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• Pa;ent recruitment remains one of the most challenging, ;me consuming and costly aspects of any trial. Without high quality search and selec;on at the beginning of a project, the results can ocen lead to poor reten;on, project delays and at worst trial failures.
• Working within stringent and approved data governance prac;ces, CC//Recruitment u;lises CC//Data to deliver a 3 step process that allows a trial organisa;on to iden;fy likely pa;ent groups, provide access to pa;ents with the support of their GP and finally provide onward pa;ent contact management.
• Using our unique data driven approach, CC//Recruitment removes the arbitrary nature of clinical trial pa;ent enrollment. Our collabora;ve approach combines the interests of the trial organisa;on, inves;gator site and pa;ent to bring a new level of proficiency to the development and delivery of clinical trials.
CC//RECRUITMENT
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• Iden;fy simple and complex pa;ent types using mul;ple indicators. Accurate selec;on ensures faster recruitment and lower fall out rates
• Conduct what-‐if analysis to build around centres of excellence
• Focus CRA ac;vity
• Lower trial failure rate
• Reduce costs
• Focused results
CC//RECRUITMENT
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• Access to data to support observa;onal, registry and health outcomes is of immense importance to achieve a robust and high quality outcome. Direct access to real world data presents poten;ally significant ;me and cost savings compared to the more tradi;onal routes of achieving data collec;on.
• U;lising granular level data, including quality of life results, enables us to support the requirement to provide ongoing assessment and analysis of cri;cal success factors, support evalua;on of benefit-‐risk data as well as deliver the post marke;ng safety surveillance remit required by regulators.
• Data immediacy is central to our solu;on. CC//Repor;ng ensures that our customers have speed of access and a degree of data transparency that will allow them to transform their own repor;ng capabili;es. Improving quality and improving outcomes.
CC//REPORTING
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• Na;onal pa;ent cohorts can be recognised and analysed.
• Each group or individual can be managed and analysed on an ongoing basis.
• Surveillance, excep;on repor;ng and QOL can be monitored on an ongoing basis
CC//REPORTING
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Thank You
Peter Watts e. [email protected] t. 07776 131954
THIS DOCUMENT AND THE INFORMATION AND DATA IN IT ARE PRIVILEDGED AND CONFIDENTIAL. THEY ARE PROVIDED IN CONFIDENCE, FOR THE SOLE PURPOSE OF EVALUATING THE CLINICAL CUBE OFFER AND MAY NOT BE DISCLOSED TO ANY THIRD PARTY OR USED FOR ANY OTHER PURPOSE WITHOUT THE EXPRESS WRITTEN PERMISSION OF THE CEO OF CLINICAL CUBE LIMITED.