The first step of this process is to type “VA01” into a blank text box.

I asked why you needed to do this and was told “to enter the order”.

Well, that explained that.

The program then goes to a second screen where you type “ZOR” into another blank text box.

“Why?” I was naive enough to ask.

“That’s what you type”.

Oh, well now I get it.

It’s incredible how willing people are to accept such low standards of usability in the programs they use every day. It’s not as though I’m the first person to notice this but honestly, no one was able to tell me why they had to type “VA01” or “ZOR” or what these things meant or were related to. It was just taken for granted that that was how you entered the order.

So instead of having a menu drop down or a button that says “enter an order”, each person working there needs to remember a set of nonsense commands because the system was set up to use humans to serve the needs of a database rather than designing a program to help people do their job well.

The value of the software in being able to enter orders obviously trumps the difficulties it creates in the way it asks you to enter them but still, funny way to build things.

MyTrials allows you to access all of Parexel’s eClinical software with a single login. A feature which has taken them a big step forward towards their goal of having a full suite of products that allow you to run a trial from start to finish.

When I first noticed this idea of theirs, I quite liked it. I think it appeals to the Napoleon in all of us (well, maybe just in me). I like the idea because it seems so much easier, a single product, a single login, all you need.

But I’ve started to question it from a strategic point of view. I believe, like Darwin and Rupert Murdoch that the future doesn’t belong to the biggest companies or the ones who can offer a broad range of products but the ones who can react to change the fastest.

To me, it looks like Parexel is focusing on size rather than speed. What happens if a customer wants part of their product line but not all of it? I’m sure customers can pick and choose to suit themselves but if a company is focused on providing a full suite of products, will they be geared to discovering and meeting new customer needs or will they just be focused inward on closing what they perceive to be the gaps in their own product line.

Should eClincial companies be trying to create a full suite of products for every occasion?

Maybe, but personally I’m interested in finding new problems and I think trying to link one solution to another is a good idea. Parexel calls this an inefficient and “cobbled together” solution in their brochure, and in the past it has been but I think that it can also be a genuine strategy in this area.

Companies that will be able to link their products to those of their competitors are going to be able to find and exploit new opportunities by moving faster than those that need to create a solution from the ground up every time.

Time will tell, in the mean time let me know what you think in the comments.

I realised that what I saw and what everyone else saw when they looked at a lettuce was a tight ball of green stuff that you put in a salad.

But what we didn’t think about was that that’s not what a lettuce is at all. They get picked when they’re young so they never get the chance to unfold their leaves and look like a plant, not a green ball. They have flowers which I’ve never seen and seeds and an ecosystem. It’s not as though they always grew in neat rows on farms. Maybe they were from the jungle or from the Sahara. I’ve honestly got no idea.

It was only by looking at the lettuce in a different way that I realised that it wasn’t just green stuff you put in salad.

Why am I writing about this?

I think that the eClincial industry today allows the same thing. It allows clinical trials to be looked at from a new angle. To be examined in new ways so that everyone involved can see new opportunities that didn’t exist even a few years ago.

I think we’re obliged to find new and better ways to do things, to explore what’s possible and create products that are really special, because to me, this is the first time it can be done. This isn’t the beginning of eClincial but I think that the opportunities afforded by the technologies available today, whether it’s cloud based programs or using home based tools to keep track of subjects, deserve to be taken advantage of.

Some people might call that eClinical 2.0, some might call it a lettuce. As long as it gets done.

I am and it turns out, it does.

I wanted to get an idea of where eClincial companies had located their headquarters so I spent an hour compiling a list of companies that I came across in searches, which were linked to on sites like http://www.clinpage.com and that I knew from memory. Not exactly a comprehensive list but I thought it would allow a general idea of where companies were located. Then I plugged them into google maps.

You can see the map below. It’s not what I was expecting. I had thought I’d see a lot on the west coast of the USA, a few on the east coast and some in Europe, Israel and India.

Here’s a list of the companies:

Akaza Research, Aris Global, Atlantic Research Group, AxxiTRIALS, Bioclinica, Bio-Optronics, BSI, Cerner, citeline, CMED, Consult Paragon, CRF Health, ePharmaSolutions, ERT, Excointouch, GoBalto, Huron, Innovocommerce, Intralinks, invivodata, Medidata, Merge, Nextrials, Omnicomm, Oracle, Parexel, Perceptive Informatics, Pharmanet i3, PharmaPros, PHT, Rubicon Clinical Technologies, Stephanini, Study-Portal, Target Health, United BioSource.

(Where a company lists multiple offices, only the first one listed has been used unless another is identified as the HQ. Also, not all of them are solely focused on eClinical but they all have eClincial products.)

What is clear though is that the vast majority (21 out of 35) are headquartered in New York, New Jersey and Boston. A few were on the west coast of the USA, a few in Europe, one in Brazil and none anywhere else (the one in Sydney is my own company (the site’s not up yet), I just couldn’t resist literally putting it on the map).

I haven’t added in all the affiliate offices, most of the companies with offices in multiple locations don’t focus exclusively on eClincial but it seems pretty clear that the eClinical companies are clustered around the pharma companies in New Jersey and the biotechs in Boston.

There’s two reasons I can think of that might explain it:
1. Staff leave the pharma and biotech companies and open eClincial companies in offices across the road.
2. eClinical companies are deliberately co-locating with their customers.

The first reason is implausible -why would eClinical companies be founded by staff working at pharma HQ’s and not offices outside their home countries, but the second one is interesting. Since eClinical companies are selling software used globally and the product doesn’t need to be physically shipped, why would an office close to customers matter that much?

It seems a bit ironic that in an industry where the products are used all around the world, in global trials run by global companies that it seems it’s still important to buy from the guy down the street.

What do you think? Is where your HQ’s location really important? Is this an opportunity for newer competitors to target their sales outside of the US east coast and the big pharmas? Do you want me to add your company to the map?

Let me know in the comments.

I’ve noticed that there seems to be a polarisation between people who think companies should have effective systems in place to make sure things are done right and people who think the systems don’t matter all that much, its about hiring good people and letting them work it out.

I think that was the attitude at my last job. Sure, all the SOPs were there but there never seemed to be a focus on identifying problems (some of which reoccurred constantly) and solving them. There was more focus was on hiring great people and getting them to work as hard as possible.

You need to hire good people and give them enough room to find their own way but I think a big part of management is to make sure that there are solid systems in place to identify and solve problems, find ways to remove as much routine, low level work as possible and provide a framework to prevent stupid mistakes from occurring.

What I’ve noticed though is that doesn’t seem to happen a lot in the clinical industry. A lot of my friends complain about excessive workloads and inefficient practices and that doesn’t seem to change no matter how much new software gets thrown at trials (there’s always something else to do).

A lot of this management style has to do with education. Everyone’s running around with science degrees but no-one seems to have read The Toyota Way (it’s not just for car companies) or The Lean Startup(it’s not just for start-ups). I’m a huge fan of science and science degrees but that’s just not enough. How is my Microbiology degree going to help me set up a sustainable system of continuous improvement so that each trial is being run more efficiently than the last?

So people hire good people, think GCP is the reason trials need to be run inefficiently and then wonder why there’s more work than there used to be, why trials are more expensive and why it all just needs to be outsourced.

There’s a nice quote from the Jungle Book by Rudyard Kipling where he says “The strength of the Pack is the Wolf, and the strength of the Wolf is the Pack”. It’s a bit dramatic maybe and I don’t think it made it into the Disney version but the point is that your team can only work well when they’re working with effective systems and software to support them so that they are working more efficiently on each trial than the one before.

Maybe this is why Quintiles have hired a consultant as their new CEO.

The most interesting speaker (to me) was Dr Tim Pratt from Crucial Clinical Business Consulting. He discussed Do-It-Yourself Electronic Data Capture (DIY EDC -maybe eClinical has a few too many abbreviations?) and whether it is really the most cost effective way for a small/mid-sized company to start using EDC.

The idea of DIY EDC is that a sponsor or CRO purchases software, or access to software that allows them to build their own eCRFs and EDC system which they then need to maintain themselves.

At first glance these systems appear to be disruptive innovation, cutting the cost of a product by reducing features, options or quality in a market where the existing players are providing more than most of their customers need and charging high prices for it (think Microsoft Excel. Most people use it to make neat tables and never even know most of the program’s features exist).

I love the concept of disruptive innovation, it’s well worth reading the original paper to understand it fully, there’s more to it than my Excel example.

Unfortunately, Dr Pratt concluded, disruptive innovation isn’t what’s happening with DIY EDC. Overall the DIY EDC systems cost more than a full service option because while the full service product has higher up front costs than DIY, the ongoing costs are much lower since the EDC vendors are specialised in this area while CROs/sponsors are not and once a full service system is up and running he CRO or sponsor doesn’t need to pay for extra staff to continually maintain it. There is also an opportunity cost to running your own EDC system -you probably want your highly trained and expensive CRAs out monitoring and your Data Managers managing data rather than maintaining your EDC system.

Key: S and T are DIY EDC systems, FS is a full service EDC system

Interesting stuff.

So what can we learn about the development of the eClincial industry from the DIY EDC example?

The DIY EDC providers tried to strip down their products in an attempt to make them as cheap as possible but according to Dr Pratt, that didn’t work.

The DIY EDC systems are obviously very flexible (they would have to be if anyone can pick them up and use them in their trial). Perhaps a better business model would be to combine the EDC system’s flexibility with working closely with clients to allow deeper integration of system within client’s operations, eventually allowing the client to take over running it once they had developed the capabilities needed to do it efficiently.

The eClinical provider may need to deliberately take on fewer clients than they would otherwise (at least initially) but by becoming a partner with their client they might be able to maintain their prices while providing a solution which is more cost effective than it would be otherwise. This is possible because the DIY EDC system should be more flexible than full service systems, allowing it to be more tailored to the client’s needs and making their trial’s more efficient than would otherwise be possible.

Would this work? Would they still be considered a DIY EDC provider if it did? I don’t know but although the industry is currently in a period of growth, it can’t last forever and not every eClincal provider will survive, if the DIY EDC providers are struggling to provide a cost effective option they may need to take another look at their strategies.

Everyone seems to be running around with “eClinical 2.0″ solutions that will streamline your trials in the cloud while maximising ROI. Or something.

So what does it all mean? There don’t seem to be too many independent (non-corporate) blogs focusing on the area so that’s what this blog is going to be all about.

I’m starting my own eClinical company -Rubicon Clinical Technologies but this blog is really just to cover my thoughts about the eClinical space, maybe comment on interesting companies and programs I come across and probably a few observations I have about trying to build an eClinical start-up.

For the moment I’ve been interested in breaking down the industry into segments. The way I see it there are 7.

1. Clinical Trial Management Systems (CTMS)

2. Electronic Data Capture (EDC)

3. Interactive Voice/Web Response Service (IV/WRS)

4. Clinical Investigator Portals

5. Trial Master Files (eTMF)

6. eSource Data

7. Other -eg. budgeting applications, ePROs etc.

That’s all for today, I’ll try and think up something more insightful for next time.

Leave me a comment if there’s anything you’re interested in, I’ll try to do some research and write a post about it.