The best alternative to paper in medical device clinical trials

There is an urban legend that paper is cheaper than EDC

$1000/subject for paper-based data management (the going rate in Israel)  is a lucrative business for small CROs, independent data managers and biostatisticians, but $1000/subject is not the same as “total cost of ownership” or TCO.

The TCO of doing a clinical trial for an innovative medical device vendor will include the time spent by the scientific staff  preparing and reducing data, additional time by the data manager to clean the data and a large intangible cost of the delay to receive management reports of patient compliance, typically 2-3 months, if you are running a multi-site study with paper.

But beyond TCO, the most significant factor in a medical device vendor decision process is how fast can  you get actionable intelligence on your patients and sites and CRO?

A 5 step process to decide how to manage the data in your medical device clinical trial

The decision to use cloud EDC (electronic data collection) or ePRO (electronic patient reported outcomes is often a point decision based on costs of a monthly cloud subscription versus direct costs of paper or a DIY solution developed by a student.  If the CEO/VP Clinical do not have the management attention or nerves for  a DIY solution they will be happy to outsource the headache to a small CRO or biostatistician who will run a paper-based study. Although paper-based data management is lucrative for the service provider there are a number of hidden costs for the customer.

In the outsourced scenario, TCO is not always calculated properly as we noted earlier. If we have to distill the decision making into a structured process – we will identify 5 components of the decision:

1. TCO (total cost, direct and indirect costs) of data management

2. Ability to gain insights (actionable intelligence on your patients and sites and CRO)

3. Implementation (who is going to set it up)

4. Accessibility

5. Security

Price – everyone likes to fly first class at a low-cost fare

Israelis are probably good examples but I suspect that most decision makers like the notion of first-class at low-cost fares. Modern SaaS technology enables this miracle to happen.  is a secure cloud service for clinical data management (collecting, storing, monitoring, searching and analyzing) for life science companies who need the highest level of support and commitment to their study success.

Insights – nothing between you and the insights you need to succeed.

Insights are based on data:  clinical measures such as did the patient take medication or not, alerts (the medication measure under threshold) and analytics (trends of compliance at sites) that translate into actionable intelligence on your sites and your CRO to hit your deadlines.

Actionable intelligence is composed of 4 pieces:

1. Automated remote real-time monitoring of all data, all sites, all the time.

2. Automated anomaly detection replaces manual site monitor visits

3 Powerful and easy-to-use risk-based monitoring of sites and CRO uncovers issues with patient recruitment, adverse events, high query rates indicative of poor data entry quality, dosing issues and more.

4. Cloud-based (or cloud computing) means that the applications are delivered over the Internet and run in any Web browser so that you can access them from any smart device. Cloud computing applications are less expensive than desktop software because you only pay to use the software instead of having to buy, install, configure, and maintain it. A Cloud-based SaaS (software as a service solution) doesn’t require a team of IT experts to set up or manage — you just log in and start using it.

Implement – the ability to customize the technology for your study

An interesting and generally overlooked point is that paper-based data management is rigid and based and batch double-data-entry and batch processing for predefined reports. Its not real-time and its not flexible.

FlaskData cloud technology enables you to define measures, real-time alerts on measures over threshold and visualization of your time-based clinical data.

In most cases when you start overseeing your CRO and monitoring patient compliance you will not know what question to ask.   The ability to rapidly define a measure – follow it, drop it and improve is something paper cannot do.

Accessibility – Monitor your study from any device.

Another hidden cost of paper is that it is not accessible until the double-data-entry is complete and someone prepares a report or Excel or MS Access database.  Access is limited to a single PC.

FlaskData works on desktop, tablet and phone. Now every member of your clinical data management team can get insights and drill down to the root cause of issues, no matter where they’re working.


Paper is probably the least secure of all options. It can get lost or have coffee spilled on it.

FlaskData runs on high-performance, secure managed  instances in the Amazon AWS, integrated EDC, ePRO and eSource with FlaskData clinical monitoring technology

FlaskData runs fully integrated with fully-validated private-cloud EDC running ClinCapture, the world’s fastest growing Electronic Data capture for clinical data management.

You can build and deploy your studies faster with the worlds fastest growing EDC and the automated compliance monitoring  of FlaskData.

Risk assessment – wrapping up the decision process on data management

A good manager will want to take the uncertainty and risk out of the clinical trial data management implementation with a secure, managed service offering and use a professional study delivery service which will help the innovative life science developer avoid the pitfalls of DIY. EDC vendors like Medrio and Clincapture talk on their web sites about speed of DIY study-builds when in fact the study build is no more than 15% of the total project timeline. If you save 1 week out of a 13-15 week process at the expense of failing validation later on – you were penny-wise and pound-foolish.

Read Jenya’s post on the dangers of self-service study build.

As in any outsourcing decision, the critical question will be “is clinical trial data management a core proficiency and core function in our business?” 

A professional study delivery will guide you and build your study, based on phase of the study, type of study, therapeutic area, features, help-desk support requirements.

Once the protocol is approved, you will be able to accelerate the study setup process to help you quickly achieve the First Patient In / Go Live milestone, using reusable CRF libraries and accelerators.

FlaskData – Fanatic service, fixed price, no strings.

This is where we make the pitch for FlaskData – you enjoy insanely great service,  fixed price, unlimited usage and no strings attached.

– Unlimited sites, subjects, data items and CRFs

– Suitable for multi-center studies

– 30x faster than SDV