Introduction

ClinSpark comes as a Software as a Service offering only. Its pricing is largely based on actual use. There are no long contractual commitments, you can cancel any month. Based on specific needs, there are three packages you can choose from:

ClinSpark Recruit is the ideal entry into the ClinSpark platform. For a low fixed monthly fee, you will have a fully functional recruitment database. It can be implemented on a stand-alone basis without further connections.

ClinSpark Lite is a fully functional version of ClinSpark, with low fixed costs. Ideal for getting started while benefiting from all the connectivity options ClinSpark has to offer. Also a cost-effective solution for smaller units.

ClinSpark Pro is a fully functional version of ClinSpark, with low variable costs. Ideally suited for medium to large units, once implementation has been completed and all studies are run on the platform.

ClinSpark Extra

ClinSpark supports the use of external locations to support Early Phase studies often conducted in partnership with the core site. It is anticipated that these external locations only work with the core site from time to time and that they will leverage the functionality of the core site infrastructure.

External locations will not receive support from the IQVIA team, they will not receive service desk accounts. All support, training, coaching, oversight etc. must be provided by the core site.

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.

External sites can collect up to 5000 datapoints per month.

If sites collect more datapoints, they require a regular ClinSpark Lite or Pro subscription.

Number of Data Points are measured as number of Item Group Data in the ClinSpark application

All prices are per site.

Exclusions

Some core sites may have multiple clinic locations, e.g. for screening participants in a neighbouring town or city, or a small number of beds (2-5) in a nearby hospital. These may sometimes be referred to as satellite sites. These sites would not be considered external sites if they:

are within a 50 mile / 80 km radius from the core site, and
use the same subject database as the core site, and
draw significantly from the resources (staff, equipment, etc.) of the core site, and
use the same SOPs as the core site

These locations would be considered to be part of the core site.

ClinSpark Pricing FAQ

ClinSpark pricing is very transparent and is published above. ClinSpark pricing is also a little different to what is typically seen in this industry. In this FAQ we explain some of the concepts underlying our pricing structure and addressing some of the questions that are often asked.

Why are you so open about your pricing?

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 sharing the pricing 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.

Do all tiers of ClinSpark have the same functionality?

ClinSpark Lite and ClinSpark Pro have the exact same functionality. Both are full versions of the software and have all functionality available. The difference is purely financial, to accommodate the use in both smaller and bigger units. ClinSpark Recruit has a reduced set of functionality and is essentially a volunteer database and supports only recruitment activities. We offer this option as a low-barrier entry into using ClinSpark. Most clients that use ClinSpark Recruit would eventually extend their use into ClinSpark Lite or ClinSpark Pro.

How do I know which tier I should use?

For small units, or at start of implementation ClinSpark Lite may be best. But for medium or larger units and after full implementation, ClinSpark Pro will likely be more cost-efficient. So really the only factor here is the amount of data that you flow through ClinSpark. At the start we make an estimate and select the best option. After that, you can monitor monthly. If you reach the point where ClinSpark Pro may be more beneficial, you just contact us and we switch you over. And if for whatever reason you would enter a period of less use, we can as easily switch you back to ClinSpark Lite again. So whichever plan you choose, you run no risk.

I only need sample tracking, why can’t I just purchase a single module?

With the exception of Recruitment, which is available separately as ClinSpark Recruit, all our plans include the full functionality of ClinSpark. We believe that it is not up to us to define which pieces you could need and bundle those in a module. As the client you are the only one able to select exactly those functions that work for your workflow. And you will likely fine-tune this even further during early use. In that process you should not be hindered by what we have put in one module or the other or even worse, suddenly have to buy extra modules because you need perhaps only one function from another module. Also we are convinced that you will like working with ClinSpark and even if you start using limited functionality, over time you will likely feed more of your processes through ClinSpark. In our pricing model you can do that without additional capital expenditure and/or extra license costs.

Also, since the pricing is dependent on actual use (for example, should you only wish to use sample tracking), a ClinSpark Lite subscription with limited usage costs will probably still be a very cost-efficient solution compared to alternatives in the market.

If I don’t have fixed monthly costs, how can I budget internally?

We believe that not having fixed monthly costs will actually benefit internal budgeting. Most Phase I units don’t have fixed monthly business. Since the costs of ClinSpark fluctuate with the amount of business in the unit, any estimates made for monthly business in the unit can be used for budgeting the ClinSpark costs as well.

If I don’t have fixed monthly costs, how can I account for ClinSpark costs in budgets to my clients?

The cost drivers for the ClinSpark variable costs are very similar to the cost drivers that typically make up a phase I study budget. The main drivers are # of assessments and # of subjects. This makes it easy to incorporate ClinSpark costs in the underlying budgeting tool that is used. If done this way, ClinSpark costs are ‘automatically’ included in study budgets and there is no risk that ClinSpark costs are not covered anywhere.

What if I do less studies than originally planned. Will I still pay the same as the estimate, or will I pay less?

For sure you will pay less! The variable costs are truly variable. So if for whatever reason you do less studies, you would generate less data points and pay less variable costs. Besides we believe that this is just fair, it also means that the cost you pay for ClinSpark fluctuate with the level of business in your unit. Peaks and troughs in Phase I are very common, so overall this pricing model helps reducing overall financial risks.

What are ‘Item Group Data’?

‘Item Group Data’ is a well defined data-item in the ClinSpark database and the terminology finds its origin in the CDISC data standards. It is very similar to what most people call an ‘Assessment’. So for example the assessment one ‘Vital Signs’ is one Item Group Data. Within an Item Group Data, there can be many more Item Data’s. In the same example of Vital Signs, you would typically see Systolic BP, Diastolic BP and heart rate as Item Data’s.

How do I know how many ‘Item Group Data’ I will use?

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?

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.

I still find this difficult to understand. Can you give me more examples?

Certainly. What is important to realise is that there can never be less Item Group Data than protocol assessments, but there are various reasons why you will record more Item Group Data than protocol assessments. In general, if you decide to record data, you can assume that those data will generate Item Group Data. Let’s give you some typical examples:

Additional recorded actions required by protocol but not classified as assessment (e.g. take supine position 10 min before ECG, mouth inspection after dosing, start fasting before dosing, etc.)
Additional recorded unplanned actions (e.g. AE’s, Concomitant medication, unplanned safety assessments, etc.)
Additional recorded planned clinic workflow activities (e.g. bag check on entrance, placement of venflon, assessment of dominant arm, etc)
Any assessments done on reserve subjects
Any assessments that record more than one Item Group Data per assessment (e.g. physical examination, medical history)
Any additional source data that you would like to record in your study

And in general we just like to be a bit on the conservative side. In the end, we don’t know what we don’t know.

So how does this work in practice? Can you give me an example calculation?

Of course. Let’s say you have a simple PK study of 24 subjects, for which you screen 36 subjects. The number of assessments could look as follows:

Screening: 14 assessments * 36 subjects = 504 assessments
Study: 104 assessments * 24 subjects = 2,496 assessments
Total assessments = 2,496 + 504 = 3,000 assessments
Estimate of # Item Group Data: 3,000 * 1.4 = 4,200.
Variable costs for this study are: 4,200 * $0.75 = $3,150 (ClinSpark Lite) or 4,200 * $0.30 = $1,260 (ClinSpark Pro)

So I get charged for my data every month the study is ongoing until it is archived?

No. Item Group charges are a one-time thing, you only take the cost in the month of data collection. Included in the one-time cost is retention of the data for as long as you retain your ClinSpark instance. Remember, data is never removed from ClinSpark, even when the study status is set to ‘Archived’.

If I have a lot of safety lab tests or complicated sample processing pathways in trial, won’t that get expensive?

No. You don’t get charged for the number of individual tests in a safety panel, just the one Item Group for collecting the sample. Similarly for complex PK sample pathways, you don’t get charged for each step in the pathway for each aliquot, just for the one Item Group for collecting the sample.

If I have many hundreds of thousands of volunteers in the database, with all their detailed social, medical medication and participation history, doesn’t that cost a lot?

No. There is no charge for any data in the volunteer database. There are only charges if and when any of that data are pulled into Item Groups in a study.

You are cloud-based, are there any hosting-costs involved?

No. All the costs for hosting the application on AWS, one of the worlds best cloud-services, are included in the prices advertised.

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.

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.

If I want to stop using ClinSpark, can I do so and at what penalty?

Why would anyone want to stop using ClinSpark? 😄 Of course we would like you to keep using ClinSpark forever, and with all our clients being happy users, we look forward to a very long relationship. Should for whatever reason you decide to stop, we will (sadly) let you go very easily. We don’t believe in contracts that go on for years when one of the parties does not want to be in it anymore. Therefore our contracts allow for cancellation by you at any time for any reason with one-month notice and without any penalties.

It is still a lot of money, where does ClinSpark save costs?

While we believe that ClinSpark is one of the most cost-efficient eSource solutions in the Phase I market, it is still a lot of money. But you will also save a lot of money. ClinSpark will likely replace legacy software systems. This could include systems for recruitment, data management, sample tracking, device management, etc. And since ClinSpark is cloud-based, it will not only save the license and maintenance costs of such software, but often also the hardware as well as costs associated with risk mitigation and disaster recovery plans.

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, ECGs, lab-results etc. by the 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.