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.”

1. Symphony™
“Clinical Data and Analysis in Harmony…
Orchestrated to deliver cost effective results.”

2. The Osmovian EDC solution was
established as a spin out from
Academic & NHS led Research.
We're a bit different to most 'EDC'
companies...
Osmovian has produced many bespoke systems for clients with complex
requirements. Examples of the innovative projects that we've done for clients
in 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. So why are we different?
• We know that software for clinical research
doesn't need to be expensive. Symphony is
revolutionary in it's 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.
We're not EDC or CTMS: we just offer you one integrated tool to get the job done
Osmovian is not just a software or IT company that has identified a
market it can sell its products in, we are passionate Life Science
specialists that have worked for many years helping companies and
organisation find solutions.
We have a passion for providing solutions that ultimately will help treat
or solve health issues worldwide.

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 Management
Symphony provides everything Symphony provides all the tools
you need to get your trial up and you need to manage your
running quickly and capture your portfolio of trials.
data live on the web.
Real Time Reporting Public Trial Space
Symphony provides real time, Symphony provides a public trial
web-based reporting allowing space where you can publish
you to analyze and extract your documents, news and generate
data. interest.

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 Portfolio
Symphony helps you to create a successful and efficient Symphony allows you to quickly and easily setup
clinical trial for drugs, devices or surgical interventions whilst participating sites/users, control user access rights, define
helping to safeguard participants and achieve your goals. You study interventions, upload and manage regulatory
don't 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 easily
entire process. Symphony's 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 electronic
and 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 Data
Once you've set up your study and built your data capture Reliable Web Hosting and Backup
schedule on line, with one click of your mouse the ‘EDC’ part
Our reliable web hosting ensures access to your site and data
of Symphony is deployed to your investigators and site staff. A
availability 24/7, allowing for enhanced collaboration with a
full 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 are
concomitant 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. 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 forms
Improve End to End Productivity throughout the entire trial lifecycle making it possible to
Symphony is the only Clinical Research System on the market implement protocol changes with the minimum of
that can help improve end to end productivity and get your hassle. You can also share your case report forms with other
trial up and running quickly. It's innovative technology and trials by using Symphony's unique case report form library.
structured workflows streamline the process of single
or multiple trial management, schedule creation, data capture
and reporting. Symphony allows you to quickly and easily Monitor and Review
setup your participating sites and users, control user access
rights 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 Symphony's source
data verification workflow.
Document Management
Symphony provides a comprehensive document management
system so that you can upload and manage regulatory and
trial related documents for distribution to your target
audience.

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 Space
Share Documents
Symphony allows you to customise your public trial space to
The public site integrates with Symphony's document truly reflect your trials' identity. Rebrand your trial space
management system allowing you to share documents that with colours, images and text that let the world know exactly
may be of interest to the wider audience. who you are!
Manage Site Applications
If you wish, you can even set up your public trial space with a
site request form. This allows potential sites from around the
world to contact you and request to join your trial, a process
over which you will have complete control.

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-ability
Symphony provides intuitive, real time, web-based reporting Symphony's adhoc reporting tool makes is possible for you to
making it possible to review your data and analyse trial create and adapt reports as the complexity of your trial or
outcome 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 Security
Symphony's role based approach to report access, ensures
that report data is appropriate to a users' access rights and
permissions. All data downloads are restricted appropriately,
and audited to ensure you have full control over the
availability of your trial data.

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 where
Pay –As – You – Go others are build by your own in-house teams. :
For individual trials or where the Clinical Trial Unit is
uncertain about the number of Trials or wishes to initially
trial 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. 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 762 371
darren.carter@osmovian.com