Archive | April 2011

Oracle launches Argus Safety 7.0…

Oracle released their latest version of Argus Safety Suite 7.0. The biggest highlight of this release is the “Multi-Tenancy”. This comes very handy for organizations that manage patient safety on behalf of more than one sponsor. This is being dubbed as a ‘CRO Release‘ for obvious reasons. However, another set of service providers that could benefit from this is the Technology Service Providers (TSPs).

Leveraging Argus 7.0, CRO and TSP organizations can host one instance of the application (not considering the various development, test, validation, training environments required) and provide technology and functional services to multiple organizations.  The software comes with all bells and whistles required for it to be regulatory compliant as well as keeps the data clean so there is no compromise of patient information and critical safety information. The biggest advantage is the feature set that will enable the CRO/TSP organizations manage the configuration required for each organization separate but at the same time enable them to be able to jump start a new organization’s configuration by leveraging configuration settings of an existing organization.

The diagram depicts a simplistic view of how this works. Please note that it does not include all the components of Argus system as well as the network elements required to ensure connectivity between the CRO/TSP to the sponsor organization. Essentially multiple sponsors will be able to connect to the Argus application through a custom/standard portal setup by the CRO/TSP.

Oracle Argus 7.0

Oracle's Argus 7.0 CRO/TSP Setup

In case of CROs, their internal staff viz. Admins, Data Entry, QA, and Medical Review personnel (depending on requested workflow by the sponsor or the CROs SOPs) would manage the cases. In case of TSPs, the Implementation (installation, configuration and support) and Hosting services could be provided by them while the sponsor manages the case processing bit.

Other enhancements to Argus Insight, Argus J and another new tool to manage Operational Analytics are slated for release throughout this year. In terms of upgrades, it comes with provision to upgrade from 6.0 and 6.0.1. However, for customers on prior versions, they would have to follow the step-by-step upgrade path till version 6 and then upgrade to 7.0.

If you need more details please write to me.


Upgrade Hell…in Life Sciences IT

Life Sciences industry is very conservative. That is really an understatement, considering the experiences I have had over the past several years. One cannot really blame them, given the nature of  business they are in, with all the regulatory constraints (in a good way) they have to work with, plus patient safety being utmost priority they are probably better off being conservative.

While this is the case, in general, with the Life Sciences organizations overall, the IT departments are forced to fall in line as well. There is no hard and fast rule but you can clearly notice, once you start working in their environment that they are at least 2 years behind the curve in terms of adopting newer tools and technologies.

This will create challenges like:

  1. Not being able to leverage the enhancements to user experience and productivity from newer tools
  2. Users being stuck with legacy technologies, while the same users are using better, improved tools on their home PCs (or for that matter, Macs)
  3. When they eventually decide to upgrade, they would be at least 2 or three major versions behind , given the speed at which vendors are coming out with new versions

The reason I brought this up is to discuss the challenges that item no. 3, in the list above, poses. This would be at multiple levels.

  1. Upgrades to the schema as well as the business process (more often than not) , not to mention the user interface
  2. Migration of data, since in most cases the generation gap would force this step
  3. Organizational change management, associated with this upgrade

While professionals like me and many others like me thrive on these opportunities, customers on the other  hand will have a tough time coping up with this. So, what do I recommend?

  1. Tool vendors should plan, along with their product management team, for complimentary tools that would provide automated upgrades (with room for customizations)
  2. If not, they should have not one, but multiple partners working with them to release an upgrade tool not for just the preceding version but for more than one prior versions

Even though this would not solve all the problems, it would at least minimize the impact on the LS IT teams and help a more conservative industry to catch up with technology and have a more positive impact on well being of human beings.

Changing role of CROs in Clinical Trials

Research Outsourcing:

Just like the Pharmaceutical and Biotech companies are realizing that IT services is a non-core activity that they tend to focus on due to growth of IT departments over a period of time. In this era of “Virtualized Everything”, outsourcing has become a common theme in IT for these organizations. Having said that, they typically outsource their R&D operations to specialized organizations like CROs.

IT Outsourcing by CROs:

CROs tend to provide mostly drug development activities, which include initiating and monitoring the clinical trials as well as providing the necessary IT backbone to manage data and documents created as part of this process. Because of renewed focus on core competencies, more and more CROs are looking for partners to outsource their IT systems and services. As a result of this, a new trend is emerging where in there would be two categories of CROs, Functional Service Providers (FSP) and Technology Service Providers (TSP).

Technically speaking, TSPs are not really CROs as they are not providing any clinical research services, however they are enabling the FSPs by providing the technology services required. The difference between your typical IT service provider and the TSP is that the TSPs should understand the Life Sciences domain. The primary reason for this is the regulatory compliance that is demanded by the Life Sciences industry in general.

Typical TSP Services:

So, what solutions and services do these TSPs provide? I think the following are some of the solutions and services these organizations can provide:

1. Technology Consulting

2. Tool Implementation and Support

3. Upgrades, Migrations & Integrations

4. Hosting Services

5. Computer System Validation

While the above mentioned services cuts across multiple areas within the clinical trial process, the question arises as to why would these organizations require domain knowledge?

Some additional functions that these teams can perform are:

1. Study setup in Clinical Data Management Systems and Clinical Trial Management Systems

2. Clinical Data Aggregation & Analytics

3. Safety & Pharmacovigilance System Setup

While the above mentioned are some high level activities, there would be always some grey areas where one would questions as to whether a specific service falls under a FSP or a TSP. For example, if you take designing CRFs, ideally you would want an FSP personnel to design these as they would understand the protocol easily and be able to translate that easily into the form design. Having said that, the CRFs also require some programming skills in which case you would need a TSP personnel. This is one of the ways a TSP differentiates from a regulat IT Service Provider.

My iPad woes

I have been an ardent fan of Microsoft for a long time. Don’t think for a second that I am writing this because I have switched sides or about to. I will continue my fandom to Microsoft despite some of their blunders during the past decade. They have made life easy for a lot of users and developers alike in the 90s, like me, with their innovative and often ridiculed UI rich operating system, applications and tools. I still happen to think that the tools provided by MS make life easy for the developers to build some of the slickest of applications with minimal effort. I know that is debatable but that is my opinion and I am sticking with it.

One of the biggest mistakes, I think, they committed in the last few years is not cashing in on their early entry into the mobile computing. While there are still a lot of handheld devices used across the world for business purposes, from a consumer stand point they missed the bus. Despite that I have been waiting for a long time to find a decent windows based gadget like the iPad, but in vain. So I eventually took the plunge and bought one iPad 2.0, despite having 2 laptops at home.

The primary reason I bought iPad was for it to be my reading and learning gadget. May be that’s two reasons :-). Basically for news, videos, virtual learning so on and so forth. While I knew that Apple has taken a stand not to run flash on their gadgets, I didn’t realize that it would be that big a deal. Fast forward a few months, now I can’t really view any websites that are done in flash. Not only that but I can’t run through some virtual learning classes that some of our vendors have made available for us to enhance our knowledge. This is becoming more and more of an annoying problem as I originally imagined I could lay down on my bed and go through these videos. Now, 50% of my primary purpose(s) is defeated.

If you think about it for a second, it appears really ridiculous how a vendor like Apple can take such a stand. Even more ridiculous is how they can get away with it. While they may have their reasons for it, the decision is hurting two parties the most. One, people like me who would love to use flash content. Two, Adobe. It not only prevents them from expanding their footprint but also brands their product lousy.

So now, I think iPad sucks, with out flash content. But for that, it is still an amazing gadget. While I would love to use it more often, this one big challenge is limiting me from enjoying it to the fullest. I am not sure if this is gonna ever be solved. So, I guess I have to live with it, just like many other decisions I might have made along the way.

We are world champs baby

Indians are world champions baby. We are no. 1 in tests, one days and now we are world champs. Can you believe it?

The team we all are used to seeing come close at times and break our hearts and at times rip our hearts and deep fry them n toss them on the grill to make sure they are charred like coal and possibly use them to grill more hearts by losing in the first round.

Today they ripped them out alright and deep fried them too, but then they threw them in a pot full of sugar syrup, spooned them out, added two dollops of creamy ice cream and topped it off with a cherry of a sixer to close the deal. What a ride? Cherish your team fellow citizens and crazies. Tonight’s your night. Cherish your team.

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