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There is a lower, license fee structure for these external locations. This pricing structure also applies when using ClinSpark to support Central Safety Lab business workflows.
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External sites can collect up to 5000 datapoints per month.
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In today’s world, transparency is the norm, not the exception. At IQVIA we are full into transparency and we believe that it helps building trust with our clients. So for us putting sharing the pricing on the website model is a logical consequence of being transparent. We offer ClinSpark in a Software as a Service (SaaS) model. For many other industries, it is very common to have SaaS offerings with public pricing. So maybe it is just something our industry needs to get used to a bit more.
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How do I know how many ‘Item Group Data’ I will use?
A: There is no definite answer to give to this question, as it will depend on many factors that can change between units. But it is possible to make an estimate. To do so, we advise to multiply the expected number of assessments with a scaling factor of 1.4. This scaling factor is an empirical number and may not be accurate in all situations, but gets a realistic estimate.
What is a scaling factor and why does it need to be applied?
A: In real-life we see that units collect more data than just the bare assessments. For example, a protocol may dictate that volunteers lie down 10 mins before their ECG is taken. If the unit decides to record that event as source data, it would trigger an Item Group Data in addition to the actual recording of the ECG. So while many would consider this to be one assessment, in ClinSpark two Item Group Data are recorded. Also, some data are collected as one assessment, but because of CDISC data structure requirements, this would be recorded as multiple Item Group Data. Medical History is an example of that. So when enrolling a subject into a study who is new in the database, recording the Medical History may result in multiple Item Group Data. However, once the subject is in the database and its data is pulled into the next study, no new Item Group Data are generated. All these effects together make the number of Item Group Data typically a bit higher than the number of assessments, something that we capture in the scaling factor.
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No. All the costs for hosting the application on AWS, one of the worlds best cloud-services, are included in the prices advertised.
Are there any other costs I should take into account?
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When do you start charging my Subscription Fee?
We will start charging you the ClinSpark Lite subscription fee upon the start of your onboarding project. This effectively ‘licenses’ you to use ClinSpark in your Sandbox and Validation environments.
You will only be charged a ClinSpark Lite subscription fee for one (1) site during onboarding.
When you go to production you will be charged the applicable ClinSpark subscription fee for each of your sites.
Are we charged for Item Data Groups during the onboarding phase of our project?
No. You won’t be charged for Item Data Groups collected in your Sandbox, Pre-PROD, Migration and Validation environments during your onboarding.
You will only be charged for Item Data Groups once your Production environment is live.
At what point does it become more cost effective to switch from Light to Pro?
We have worked out that as soon as you collect more than 150,000 item data groups it is better for the customer to switch to ClinSpark Pro.
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Are there any other costs I should take into account?
There are no further costs for IQVIA. However, for the system to run, you will need a reliable internet connection and computing devices (laptops, tablets, desktops, barcode scanners, etc) that fit your workflow. Also, for certain functionality, when ClinSpark connects to external systems, the licenses and/or usage costs of such systems are not included in ClinSpark costs. These would for example be Twilio for phone/messaging support, MedDRA license, etc. In the proposal we will make for you, we identify those areas specifically so you can plan and budget for those.
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In resource use, there will be huge savings in (lack of) transcription, QC processes, data querying, data cleaning, etc. Also, paperless workflows for review and sign-off on eligibility, ECG’sECGs, lab-results etc. by the Principle Principal Investigator will save a lot of resources.
Overall we believe that ClinSpark will save you money. But still we would not present ClinSpark as a cost-saving tool. Instead we believe that the main reason for using ClinSpark is increased quality and subject safety. Immediate insight into the safety of the volunteers, the availability of full medical history and study data of current and past studies in case of emergencies, a single source of truth, in-process data-checks, sponsors having real-time insight in the course of the study, the ability to do remote monitoring, the ability to export SDTM-like SAS XPT datasets for downstream processing and analysis etc. etc. are what really provides value.