Cloud computing was previously debunked famously by Larry Ellison – the founder and CEO of Oracle.

Of course, Larry Ellison is not an idiot. He is a business man.  Oracle have billions vested on non cloud technology.  Embracing cloud too rapidly would torpedo much of Oracle’s core business – Client/Server.  It would turn many of the things that are done today into commodities where the underlying technologies such as the Database that is used become irrelevant to the Technology consumers.

We have already seen this in the EDC world.  In 2005 – you could hardly sell an EDC system if it was not running on an Oracle database.   Today – provided service levels are met, clients just don’t care.  Software-as-a-Service started the change – Cloud is completing that transition.

Sadly as the tide of opinion has moved towards the acceptance of cloud computing, the opposing vendors have decided to jump on the boat.

We have terms such as ‘On Demand’, ‘Always On’ or even ‘SaaS’ although there is a difference.

One of the defining features of cloud computing is multitenancy — the ability to provide a single platform for all users regardless of role or organization.  This is not easy to provide, and virtually impossible to reverse engineer. If you have a platform that is not multi-tenancy – then chances are, it is going to remain that way.

Multi tenancy applied to the world of EDC means that all Pharmaceutical companies, CRO’s and sites would access a single instance of the system (possibly through different URL’s) and that the underlying data would be stored in a single (logical) database.

On the surface, this appears to be a very risky strategy – surely one user, could easily see another users data?!?

In reality, computer systems have been doing this for 30+ years.  Data has been kept separate at a ‘lower level’.  For example, often, a hosting firm will have multiple installations of software with multiple databases… these could be physically hosted on the same hardware – data from one installation is sitting next to data from another.   Data is kept separate by software….  With single instance / multi-tenant systems, we have the same thing. It is just the application software rather than the Operating System that keeps the data separate.

So – why cloud – where are the advantages?

Cost & Scalability

Adding a user to a cloud hosted and architected platform costs next to nothing.  It does not require an engineer to install software, or to add new hardware, or to reserve disk space or any of these tangible cost items that you may find with traditional systems.   Cloud systems are all about capacity management.  If you add another 1000 concurrent users, you might need a couple more slices of processing power… but… that is easily carried out in cloud – you simply utilize capacity.  Slide a new server into a rack… press a few buttons, and your system can utilize that extra capacity.

With Cloud eClinical, we will see Clinical trial technologies increasingly becoming a commodity. Prices will drop, and competition will increase. The beneficiaries will be the patients that receive drugs from cheaper faster trials.

As of February 2013 – no EDC vendor provides a full cloud based solution – but that will most likely change. The larger firms will develop or procure cloud based solutions leading to increased margins and lower costs.


This might seem back to front – surely a system where all users go to the same system and database will be less secure?   On the contrary. By simplifying and focusing the user management and security in one place, we create a far more effective and efficient platform.   With the traditional systems – you might have a user with many user accounts – one for each instance. This is typically the case with EDC.  To manage this, users write down, or, re-use accounts and passwords…. users complain if all the different passwords have to change frequently… in response, vendors relax the password reset rules….

With an application level cloud security solution, the controls are provided to the users.  In the Clinpal platform for instance, the user assignments are hierarchical.  A site administrator can add / invite other users to that same site.  Leaving that sort of task to an IT Administrator just opens up risks of the wrong people having access to data.


I have long held the belief that standard such as CDISC have struggled to fully take hold not because of the standards themselves, but because of the way in which standards were supported by vendors.   Interfacing to 30 studies on 30 instances of an EDC product is a pain in the neck – even with CDISC standards.

With a cloud platform – you are able to implement a secure, always on configuration that exists for all circumstances.   Companies that wish to interface to a cloud EDC system simply needs to set it up once (if done properly), and the the same interface will work for all studies and all sponsors.

I believe this single factor will be recognised as the ‘must have’ reason for cloud eClinical.    Integration between systems will not be a ‘pain’ to endure for each study.  It will be an expectation.


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