Osmovian EDC Brochure

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A overview and guide to a low cost EDC (Electronic Data Capture) product offered by Osmovian for Clinical Trials.

"Clinical Data and Analysis in Harmony…
Orchestrated to deliver cost effective results.”

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Osmovian EDC Brochure

  1. 1. Symphony™ “Clinical Data and Analysis in Harmony…Orchestrated to deliver cost effective results.”
  2. 2. The Osmovian EDC solution wasestablished as a spin out fromAcademic & NHS led Research. Were a bit different to most EDC companies...Osmovian has produced many bespoke systems for clients with complexrequirements. Examples of the innovative projects that weve done for clientsin the past include:• Integration with other healthcare databases• System deployment within the UK NHS secure network environment• Allowing patients to see their own data securely• Direct patient input to web data collection• SMS/text notifications to patients and investigators• Capturing feedback from patients directly from SMS/text messages
  3. 3. So why are we different? • We know that software for clinical research doesnt need to be expensive. Symphony is revolutionary in its pricing: no other clinical research software offers such fantastic value for money. • We want to make life easier, not more complex. We pride ourselves on ease of use and minimal training requirement. Web software should serve the user, not the other way round. • Everything in one place. Were not EDC or CTMS: we just offer you one integrated tool to get the job doneOsmovian is not just a software or IT company that has identified amarket it can sell its products in, we are passionate Life Sciencespecialists that have worked for many years helping companies andorganisation find solutions. We have a passion for providing solutions that ultimately will help treat or solve health issues worldwide.
  4. 4. “Create, manage and report on your Trial(s) with an easy to use feature rich and low cost friendly system.”Build Your Study Project ManagementSymphony provides everything Symphony provides all the toolsyou need to get your trial up and you need to manage yourrunning quickly and capture your portfolio of trials.data live on the web.Real Time Reporting Public Trial SpaceSymphony provides real time, Symphony provides a public trialweb-based reporting allowing space where you can publishyou to analyze and extract your documents, news and generatedata. interest.
  5. 5. Build Your Own Study Symphony can help you to create a successful and efficient clinical trial for drugs, devices or surgical interventions. Add your new trial, sites and users quickly and easily. Create and publish your electronic case report forms ready for data entry. Manage trial documents and recruitment.Create a Successful and Efficient Trial Manage Your Trial PortfolioSymphony helps you to create a successful and efficient Symphony allows you to quickly and easily setupclinical trial for drugs, devices or surgical interventions whilst participating sites/users, control user access rights, definehelping to safeguard participants and achieve your goals. You study interventions, upload and manage regulatorydont need to be an expert user to set up a study in Symphony documents and build and publish your case report forms.- our easy to follow workflows help guide you through the Store trial related documents centrally so that they are easilyentire process. Symphonys user friendly interface makes it accessible to the relevant participants. You can easily,easy for you to manage and monitor recruitment and control effectively manage single or multiple trials simultaneously,site participation whilst ensuring the completeness, accuracy transferring your protocol into a comprehensive electronicand consistency of the data collected. study. Create visit schedule and CRFs quickly either from template libraries which help eliminate data duplication, or by defining the data types you want.Collect Your Trial DataOnce youve set up your study and built your data capture Reliable Web Hosting and Backupschedule on line, with one click of your mouse the ‘EDC’ part Our reliable web hosting ensures access to your site and dataof Symphony is deployed to your investigators and site staff. A availability 24/7, allowing for enhanced collaboration with afull audit trail is provided of all entries made and standard worldwide audience. Symphony is completely web-based,procedures and nomenclature are used for AEs and SAEs, with no need to install any software on your PC. Your data areconcomitant medications and Source Document Verification automatically backed up regularly to two separate(SDV). destinations. If you have particular requirements for web hosting arrangements please contact us.
  6. 6. Project Management Symphony allows you complete control over your trial portfolio. Follow and control trials, sites and patients through the entire process of setup, recruitment and treatment. Symphony allows you to review the status of all your trials as they progress to completion. Schedule Creation With Symphony, you can create and publish your schedule electronically and version control your case report formsImprove End to End Productivity throughout the entire trial lifecycle making it possible toSymphony is the only Clinical Research System on the market implement protocol changes with the minimum ofthat can help improve end to end productivity and get your hassle. You can also share your case report forms with othertrial up and running quickly. Its innovative technology and trials by using Symphonys unique case report form library.structured workflows streamline the process of singleor multiple trial management, schedule creation, data captureand reporting. Symphony allows you to quickly and easily Monitor and Reviewsetup your participating sites and users, control user accessrights and define study interventions. Monitor and review recruitment, data entry, adverse events, concomitant medication and trial medications as the trial progresses. Validate your data against source documents in the least labour intensive fashion with Symphonys source data verification workflow.Document ManagementSymphony provides a comprehensive document managementsystem so that you can upload and manage regulatory andtrial related documents for distribution to your targetaudience.
  7. 7. Public Trial Space Symphony provides a customizable public trial space, allowing you to publish information and documents to share with a wider global audience. Make your trial your own! Brand Your Trial SpaceShare Documents Symphony allows you to customise your public trial space toThe public site integrates with Symphonys document truly reflect your trials identity. Rebrand your trial spacemanagement system allowing you to share documents that with colours, images and text that let the world know exactlymay be of interest to the wider audience. who you are!Manage Site ApplicationsIf you wish, you can even set up your public trial space with asite request form. This allows potential sites from around theworld to contact you and request to join your trial, a processover which you will have complete control.
  8. 8. Real Time Reporting Real time, web-based reporting makes it possible to review your data and analyse trial outcome at the touch of a button. Symphony provides interactive reporting with the ability to export into .xls, .csv and .pdf formats.Intuitive Real Time Reporting Scale-abilitySymphony provides intuitive, real time, web-based reporting Symphonys adhoc reporting tool makes is possible for you tomaking it possible to review your data and analyse trial create and adapt reports as the complexity of your trial oroutcome at the touch of a button. Symphony provides feature- data needs change.rich, interactive reporting with the ability to export into .xls,.csv and .pdf formats.Data SecuritySymphonys role based approach to report access, ensuresthat report data is appropriate to a users access rights andpermissions. All data downloads are restricted appropriately,and audited to ensure you have full control over theavailability of your trial data.
  9. 9. Costing Options Osmovian offers Symphony under 3 basic costing models, these are provided to offer the broadest cost effective models to drive real value in the deployment of an EDC solution on your Trial(s). Modular options would be available should you wish to mix the options for specific trials, where you could call upon the expertise of the Osmovian team to build specific pages or specific trials wherePay –As – You – Go others are build by your own in-house teams. :For individual trials or where the Clinical Trial Unit isuncertain about the number of Trials or wishes to initiallytrial the product: Technology Transfer Program Fully hosted solution Where Osmovian would train the £99 per Trial Per Month and; relevant staff to design and build the eCRF/Reports and 99p per patient per month documentation to GCP standards. Training is provided at a rate of £750 per day, plus any expenses, at cost, should the training required be for longer than 1 day. And then the Managed Trial Program addition ongoing cost would be as: Fully hosted solution Where Osmovian would design and build the eCRF and reports structure to the specification set We can offer a fixed package. i.e. by the trial protocol and through discussions and we would document to ensure compliance with ICH/GCP. Cost of which • 0-10 clinical trials hosted @ £2000.00 -£2500 p/m would be £350 per eCRF page for the design and build. And (including support, hosting) then: • 11-20 CTs hosted @ £2500.00- £3000.00 p/m (including support, hosting) We can offer a fixed package. i.e. • 0-10 clinical trials hosted @ £2000.00 -£2500 p/m (including support, hosting and training) • 11-20 CTs hosted @ £2500.00- £3000.00 p/m (including support, hosting and training)
  10. 10. Next Steps Should you like what you have read here and are in the process of reviewing your EDC requirements for current or forthcoming studies, Please feel free to contact us on the details below and we would be happy to arrange a no obligation online demonstration or even arrange to come a visit your site and provide a more detailed demonstration. FOR FURTHER INFORMATION CONTACT: Darren Carter +44 (0) 7794 762 371darren.carter@osmovian.com

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