Pricing from the big EDC vendors is complex and confusing and the overlap between CRO clinical data management services and their EDC solutions locks you into a proprietary system of high-costs and expensive professional services.

The non-transparency of the clinical data management market

As the CEO of an innovative biomed or biotech company doing clinical trials, you have real skin in the game.

You have a challenging job in front of you. You want to increase your control over data quality, accelerate product development and improve study compliance and meet FDA guidance for your submissions. You have special requirements and are looking forward to your commercial release and considering how you can ensure high quality data capture after your clinical trial. All this at the lowest possible cost.

When you speak with EDC vendors and CRO companies, you encounter a clinical data management market that is complex, confusing and markedly non-transparent. The array of options is confusing. We will try and clear the smoke and mirrors and help you make the right decision on clinical cloud services for your next clinical trial. We hope that you find this paper useful in your decision process.

Question #1 – Should I use paper CRF or a managed clinical cloud service?

There is a commonly-held belief in the clinical trial industry typical among small biomed/biotech sponsors that paper CRF is cheaper. As we will see, the claim that paper is cheaper than cloud is unfounded. Let’s examine the value proposition of paper versus clinical software as a service.

The going price for processing paper CRFs (case report forms) for your study including double data entry is about $1000-1500/subject. A 12-month study with 100 subjects will cost you about $100,000.  At the end of the study, after data lock, you have a tedious, time-consuming and nerve-wracking process of data cleaning. Since you have been collecting data from sites using paper, your monitoring processes are slow, cumbersome and almost certainly incomplete. Your ability to have 360-degree view of all of your sites is almost nil and if there are any data quality and subject safety issues, you may discover them in 2-4 months after they happened.

Compare paper to cloud services using Open source technology

Now compare paper with a managed clinical cloud service from a specialty cloud service provider like FlaskData.io that leverages Open Source technologies like ClinCapture, PostgreSQL and Google Charts. Let’s consider cost: your 12-month multi-site study can cost as little as 1/3 the cost of paper depending the complexity of your protocol. Then, let’s consider data quality. A clinical trial is a scientific experiment designed to prove or disprove a scientific hypothesis. Problems happen. Changes will be made and surprises creep up on you. A holistic cloud platform that combines online data collection with patient compliance automation enables you to be up-to-date on all of your sites all of the time and see the trends know within hours instead of months.

Question#2 – Should I use a big vendor like Medidata or Oracle or a vendor like Flaskdata who leverages the best Open Source technologies.

The high costs of proprietary closed source solutions from companies like Medidata and Oracle are causing biotech, medtech and biopharma sponsors to seriously consider innovative, game-changing alternatives from specialist cloud service providers like FlaskData.io. FlaskData.io leverages the power of commodity cloud computing with Open Source infrastructures with proven expertise in databases, data security and risk analysis. A business philosophy of total data portability frees you from vendor lock-in and grants you complete freedom of choice.

This powerful combination of Open Source, commodity cloud, professional expertise, high quality, regulatory-compliant software as a service and freedom of choice at a fraction of the price of offerings is a game-changer for consumer and medical device studies that cannot afford the high costs of the big vendors.

Question#3 – Should I run my own EDC system in-house or use a Cloud EDC service?

With the rapid development of cloud computing and Open Source EDC solutions, many sponsors are considering running EDC systems themselves. A small to mid-sized sponsor does not have the technical, operational, software, security, data protection and clinical data management resources to run their own in-house EDC. By using a managed clinical cloud service like Flaskdata, sponsors dramatically reduce their total cost of ownership and make the complexity of operation go away. With a large number of competitive Cloud EDC solutions on the market, a savvy sponsor will be able to obtain a competitive quote for a private-cloud solution for all of their studies.

Question#4 –Should I consider remote risk based monitoring?

100% SDV contributes less than 2% to data quality and costs between 25-30% of study cost. This widely quoted number relates to the monitoring costs of large Phase IIB and Phase III trials that are not price-constrained (Since a Phase IIB trial is often the last step before licensing the technology or selling the company; “money is no object”.) .  There are over 200,000 active registered studies. 20,000 new studies are initiated every year but about half of all new studies are either unmonitored or use very thin monitoring from a CRO since they have a limited budget.

However – beware:  remote risk-based monitoring helps you manage risk of sites not assure protocol adherence of individual patients.

The alternative to risk-based-monitoring which is back-office data management process is automated detection and response in real-time based on continuous data feeds from EDC, ePRO and devices.

Automated detection and response is 1000X faster and 1/10th the  cost of onsite monitoring services and 100% SDV. More importantly, since you can resolve issues in real-time, you can reduce the time to your statistical report from 6 months in a paper study to 1 month.

Question#5 –Is Excel or Google Forms  a valid solution for me?

There are cheap Web-based applications for forms management such as Mach forms or Google Forms. Freelance programmers will tell you that they can develop a cheap solution. These solutions are not 21 CFR Part 11 compliant, they are not validated to GCP and lack 90% of the pieces of a GCP-compliant EDC solution. A cheap forms-driven or DIY solution will put your entire study investment at risk the first time you have a severe adverse event and have to prove traceability and accountability.

Ask your freelance programmer how much he would charge for all the functionality in a popular Open Source EDC system like Open Clinica or ClinCapture, currently used by thousands of sponsors globally.

Summary

With the convergence of open source, commodity cloud technology, high levels of expertise in data management and data security, and the introduction of automated detection and response; the time has never been better for innovative biomed and biotech sponsors to bring their products to market.