IT in Pharma - Special

CROs on mission IT

The IT requirement of Clinical Research Organisations differ based on their business activity. Nandini Patwardhan explores the various clinical research automation solutions being implemented by CROs.

Given the very information-oriented nature of their business, Clinical Research Organisations (CROs) are at the forefront of Information Technology (IT) adoption. This sector has deployed a variety of IT solutions that enable them to key in, analyse and interpret volumes of data and report as per the standards laid down by the regulatory bodies.

The wish-list

Normally, the IT requirements of CROs vary depending on the kind of business activity they undertake. "Some CROs do only data management, while others do clinical trial management. Then there are some others, who are into data capturing. So, it depends on the kind of outsourcing jobs that these CROs have, which eventually determines their technology needs," explains Subhomoy Sengupta, Director, Applications Sales at Oracle.

A CRO needs IT solutions in areas ranging from data management, clinical trial management for statistical analysis, data backup and so on. Further, IT-based solutions are required for maintaining database of investigators, trial material inventory management and for enabling collection of data from subjects through various electronic gadgets, such as patient diaries and programmed electronic devices. "There is no end to requirement of IT in a CRO. It takes shape as the organisation grows. In the CRO industry, compliance to regulatory requirements such as CFR Part 11 and validation of systems plays a major role," states Venkatraman Sunder, Vice-President, Operations, Asian Clinical Trials (ACT). "For instance, at ACT we have automated data management, clinical trial management and the document management system," he adds.

What is in?

Currently, all the data management activity is automated and ACT has a capability of creating an electronic CRF to capture the data online from a site, which will reduce the time of data management substantially. This will also enable the CRO to lock the database within the shortest period of time possible and submit the data for analysis.

ACT also uses a clinical trial management system, to reduce the paper flow within the office and also between the CRO and the sponsor. This system serves as a single source of information on the status of any project, either by the CRO or by the sponsor. These implementations have helped them cut down the data closure time for sponsors substantially.

Wellquest, on the other hand, has implemented IT solutions in the analytical aspect of operations. "All my analyticals are covered by IT. As far as clinical side is concerned, we still use manual paper, which is the same case with many CROs, who are in the BA/BE studies," affirms Aravinda Babu P, Vice-President, Head-Operations, Wellquest Clinical Research.

"We have software packages like WINonline, SAS, Class VP and STMS called NuGenesis. These are all Windows-based for better data authentication, data sanctity, data storage, retrieval and production," he adds.

Similarly, the Hyderabad-based Vimta Labs too have invested in SAS, WINonline and NuGenesis. "Indian CROs at present are driven by sponsor and regulatory requirements. What is acceptable to regulatory bodies is implemented on top priority basis. For example, we are using software tools acceptable to regulatory bodies such as USFDA and European regulatory agencies," elucidates Dr I S Gandhi, Medical Director, Vimta Labs.

Self reliance

While most CROs implement off-the-shelf solutions, there are some like the Mumbai-based iGATE, which rely on in-house solutions. iGATE has developed and implemented Electron, which is validated and is 21 CFR Part 11 compliant. It is capable of both paper, as well as Electronic Data Calculation (EDC).

"The rationale behind the in-house development is a general observation, that when you take an off-the-shelf solution, you have a little bit of limitation in customising it to fit your process perfectly, and many a times you end up titrating your process to the capabilities of the software," explains Vasudeo Ginde, President and Managing Director, iGATE.

However today, the CRO is exploring off-the-shelf solutions to manage and present information to its customers in a universally accepted format. "A lot of the clients have taken a close look at our systems and liked it because of the flexibility, transparency and the work that we do here. But when it comes to data management, it doesn't really matter how good your internal software is. It is their need and then you got to do that," declares Ginde.

Popular products

There are many solutions available in the market from well known players like Oracle, SAS, Microsoft, and also from some smaller players. "The packaged solutions essentially fall into two categories; one is data management, which is where SAS is reasonably strong. The other part is clinical trials management, which is Oracle's strength area," says Sengupta.

SAS's PheedIt is a Web-based solution built on the SAS platform. According to George Varghese, Director, Pharma, ITeS and Mid-markets, the software centres on the four pillars of SAS technology are—usability, manageability, scalability and interoperability. "Frankly, most CROs operate on the Windows platform and I have rarely seen any working on a UNIX. But in case they need to do that in the future, for any other kind of application, SAS supports that. We are oblivious to the kind of hardware or operating systems that they use. It's a truly open system," explains Varghese.

"As far as Oracle Clinical is concerned, it is a proven solution, which has been tested and has been working in this environment which is highly regulated. Most of the jobs that CROs get are from global pharma players, where clinical is also a part of the job. Thus, there is a big push from the pharma companies for CROs to remain on Oracle Clinical," states Sengupta.

Benefits galore

In addition to giving a fillip to the overall quality of data generated, IT also helps in cutting down the costs and time involved for conducting various processes. "Additionally, it also reduces paper load required for regulatory submission, allows sharing of data with sponsor on real time basis and reduces site visits for data monitoring," explains Gandhi.

"IT implementation increases the validity of the data generated as it cannot be manipulated. Also, the back-up functions ensure that the necessary data is still available even in case of adverse situations like a fire. Audit trials capture any changes along with reason for the same, which needs to be recorded. So even two to three years down the line, a person can see from the server level and not only from the computer level," explains Babu. IT also enables the removal of 'individual' from the whole equation, by making the process individual-independent.

Look before you leap

However, it may not be a very wise decision to implement IT solutions just because it is the current trend. IT is a double-edged sword. While it can help CROs streamline their processes, there also have been situations, where CROs have implemented solutions that have made processes more tedious. Also, the investment made by CROs can range from Rs 50 lakh for basic systems to a few crore. Hence, any kind of IT implementation needs to be backed by sound thinking and a compelling reason.

"The first step is to evaluate the strategic information management needs of the sponsor, regulatory agency and the investigator team, which are essential from the scientific and ethical perspective," states Gandhi. After identifying the needs, it is necessary to prioritise and submit them to the authorities to sanction the required budgets. "There is not much problem in getting the budgets sanctioned, as the extras that might be needed, extra computers or the renewals, are always taken into account," explains Babu.

Once the budgets are sanctioned and resources (both hardware and software) are made available, it is necessary to train people and monitor the progress and status of prioritised IT projects. The most important part of any IT implementation is the choice of vendor. "I assume that all the global software providers have their basics in place, in terms of 21 CFR compliance, audit trials and business continuity plans," clarifies Ginde. "So what differentiates one player or an offering from another is that there are other parameters like the ease of standardisation, robustness, availability of reports at a click of the button and smoothness of processes using that particular software," he further adds.

Varghese has a different perspective on this. He opines that customers will not be interested in understanding a product's performance levels in case of established brand names. What they will look at is the kind of support provided in terms of training, implementation and 24x7 technical helpline. Giving an example of Toyota Corolla, he asks, "When Toyota Corolla was launched in India two years back, did people have a problem buying that? However, people will definitely be interested to find out whether you have a service centre, can I get my spares, as and when I want it. So those are the things that people will look at." Both Oracle and SAS offer implementation guidance and training to the customers' executives once the implementation is done.

The crux of any IT implementation is not just installing the necessary software on a machine. It is a process that starts with detailed need analysis and ends with comprehensive training. Otherwise, the whole initiative will backfire and may result in the orgnisation becoming IT averse.

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