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Clinical

What is Snap.Clinical ?

Snap is an acronym for "Software ??? Not A Problem". It is a product family built by Clinnovo Research Labs based in Hyderabad, India to challenge the conventional notion that software has to be complex, huge, come with a hefty price tag and special hardware. Snap.Clinical is a specific instance developed for Clinical research. The product has been developed over 3 years and was used within studies done by Clinnovo. The international release date is set for August 1st 2009.

Meanwhile you can experience the beta version here . Note that this version lets you see the software but not use it. In this documentation Snap refers to Snap.Clinical.

Can I run multi-center trials ?

Snap.Clinical is trial site specific. You could be part of a multi-center trial, but Snap.Clinical is specific to your site and organization. This automatically makes it not suitable for large pharma. We have another product in development to cover exactly this, and will be released as a separate product.

Can I run BA/BE studies ?

Yes. A special module is available for BA/BE studies which includes dosing schedules. You can record all pharmacokinetic measures (AUC, Cmax etc.,) with in the system. The data export will be as Excel files and you can use NONMEM or use our service provision.

Can I run Pharmacovigilance studies ?

Partly Yes. A special module is available for Pharmacovigilance studies which includes Causality assessments, managing case reports and a Reporting framework. Currently reporting to EU authorities is not included.

Can I run Imaging studies ?

Yes. Snap.Clinical support DICOM and Analyze data. In some cases we have analysis software already in place (ex: Skin lesion analysis, lung segmentation etc.,) However you need not use our software and can choose to use other tools like Matlab. You should consider the extra cost of database since the imaging data tends to be larger in size. Currently there is no native DICOM support, and we are considering Oracle 10g as a database option for this.

Can I run Pre-clinical or animal studies ?

Partly Yes. We have no specific module for this but would be happy to get your suggestions.

Is it less complex ?

Snap is built around concept that software has to adopt to an organization and not the other way around. Also to do one project today you need a plethora of tools which is make it complicated and slow.

Is it Cheap ?

Snap is priced for small and mid-size clinical research organizations. The target price for whole package is not set expected to be around 1,00,000 INR (~2000 USD) to 5,00,000 INR (~10,000 USD) for multi-user per site license. The cost is dependent on how much customization you want, and what modules you select.

Oh, thats still expensive

For academic research centers we can discuss modified pricing. This will be part of a partner program <> which requires Clinnovo team member to make a short visit to your site or work closely with you.

Why is it not Free ?

We expect organizations to use Snap.Clinical when they engage us, giving it free would make the effort we took building it look irrelevant.

Is it small ?

Snap is modular in the true sense, so you can pick out and combine any module that may suite you. There is no special hardware, and it is a single software install. If you pick less modules you cost will decrease, and you can always upgrade or downgrade. Downgrades will lead to loss of data in that specific module, and may not be refunded.

Does this have any patents ?

Clinnovo believes in open innovation, and has a policy not to patent. Patenting increases the cost for us and in turn to the users. Any organization is free to replicate our ideas and offer similar functionality. Snap is copyrighted but we would be happy if many companies copy it.

What is Clinnovo ?

Clinnovo is not started by folks from IIT/IIM/Harvard, is not backed by Angel Investors or Venture funds and was not started in garage - it s just a common sense company. Snap product team consists of 12 people, of which only 5 are programmers rest are clinical researchers split between India, US and Europe.

What additional hardware does it need ?

It can be run offline or online. In offline mode you do not need a database, but the amount of data you can store will be limited. In online mode you will need a database. We provide connectivity for MySQL as a part of the product license. If you need connectivity for postgresql or oracle it would be a service provision. The client can be any PC/Laptop. Support for smart phone and PDA is limited to data entry now, but by Q2 2010 we expect a full-functional mobile version. The server can be on Linux/Windows/Mac.

What are the weaknesses ?

It is very simple to use and does not suite organizations that prefer complexity. It is not yet tested for 21 CFR Part 11 compliance. It is backed by a small company. The back end database (MySQL) does not have extensive roll-back capabilities.






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