The possibility of full laboratory automation represents a huge opportunity to the contract research sector. Not least in the commercial benefits that improved productivity and faster study turnaround can bring. In order to realize these benefits and respond to the pharmaceutical industry's expectations and regulatory pressures, Contract Research Organizations (CROs) are placing increased reliance on Laboratory Information Management Systems (LIMS) to facilitate laboratory automation. This acceptance of the benefits of LIMS by the contract research world is, quite rightly, based upon clear business needs and pressures. However, all too often, an investment in LIMS is technology led and takes little account of implementation requirements to ensure the software precisely meets the business's objectives.

The value in the service a CRO provides is in the quality and timeliness of data it delivers to sponsors. Considering a typical CRO's spending levels on laboratory equipment, people and facilities to obtain this data, an investment in the implementation of a system to acquire, analyze and report this data must be justifiable.

This article looks briefly at the requirement for laboratory automation, the role of the LIMS in the CRO, the process of LIMS and supplier selection and the business risks and rewards involved during the critical implementation phase.

The pressure to automate has never been greater than in today's pharmaceutical industry and this has led to a corresponding reliance on LIMS to help manage the data generated, particularly among CROs. Contract laboratories, in particular, have focussed on how technology can deliver better performance in terms of speed, reporting, accessibility, availability and accuracy of data.

There are a number of external sources of pressure to automate laboratory procedures. Fast becoming a prerequisite of pharmaceutical industry sponsors, laboratory automation and computerization is nowadays being viewed as an expectation of the regulatory authorities. For example, in the USA, the FDA's published guidelines on electronic submissions and recent ruling 21 CFR part 11 on electronic records and signatures are indicative of the way the regulators are considering the future of laboratory automation.

However, even as recently as the early '90s, online data collection was used as a selling point by CRO representatives, while nowadays, it is the market's minimum expectation. On the other hand, client access, allowing the monitoring of data mid-study, has been a more recent differentiator promoted by CROs.

How long will it be before this service becomes de rigueur?
In the fiercely competitive market in which they operate, CROs are constantly seeking an 'edge' in the services they offer and are looking at the role improved use of technology can play in achieving this.

CRO REQUIREMENTS OF LIMS
By the extremely diverse nature of the analytical services they offer, contract laboratories place extra demands on LIMS capabilities. Scientists in contract laboratories utilize LIMS to track the various projects which are in the system at any one time, in the same way as many laboratories would. However, a LIMS in a CRO must also have extensive features for handling pricing, quoting, discounting, and client information management.

As most contract laboratories serve multiple clients with differing needs, it is not possible to establish a small set of standard tests that will be applied to a limited list of sample matrices, which further extends the demands on a LIMS.

Flexibility in reporting is a requirement of LIMS specified by all industries. CROs stretch this requirement in their efforts to satisfy the reporting conventions and house styles of their sponsors. Specific requirements, as mundane as page numbering and the incorporation of sponsor's logos on consecutive portrait and landscape pages in a report, can be a headache to a CRO without a sophisticated reporting function in its LIMS.

Typically, CROs also specify high configurability as a priority in lists of LIMS requirements. A configurable LIMS allows the system to be tailored to match evolving laboratory workflows, etc. without compromising the core integrity of the software.

Such requirements of LIMS are common to all industries, but the needs of the pharmaceutical contractor can be the most demanding, due to the combination of the high degree of regulation and wide variety of work conducted. Only a very versatile LIMS can accommodate the requisite functional and technical flexibility for a CRO.

"BETTING THE BUSINESS"
Minimizing risk is arguably the most important aspect of a large IT project to a CRO. To a modest sized CRO that has chosen to harness technology in a bid to increase its competitiveness, its investment in LIMS selection and its implementation can amount to "betting the business". This expression does not, in fact, come from a LIMS supplier but from a CRO executive, during the evaluation phase, when stressing the critical importance of a LIMS project to his organization.

There is obviously a clear balance, therefore, to be achieved between introducing new technology, realizing a rapid return on investment in critical areas and the need for a low risk solution. It can be argued that, in selecting and implementing a LIMS, a CRO is taking a greater risk than a pharmaceutical company. While for a large CRO their financial investment in a LIMS may be similar, it is most certainly a bigger commitment in terms of percentage of turnover. Furthermore, it is unlikely that a CRO will have the same levels of experience in implementing large IT projects as a pharmaceutical company (such as human resources, accounting and enterprise resource planning systems), so the risk of project failure is heightened.

To summarize, the CRO faces a real financial gamble in an investment in a LIMS. The stakes are high and minimizing risk in the critical implementation phase can be the key.

PROJECT FAILURE
Much has been written on IT project failure and minimizing risk. What can surprise many potential LIMS users in CROs is that the reasons for project failure are seldom simply technical. No matter how functionally rich and easy to use a system may be, if poorly implemented without the necessary skills and backup, the chances of project failure are significantly increased, as are the chances of receiving little or no return on the investment made.

Unfortunately, however, technical issues are often seen as being more important in LIMS project planning than the 'softer' issues of system implementation. It is important to see why this may be so.

It is generally recognized in many organizations including CROs that a LIMS is a strategic, and often mission critical application. The success or failure of an implementation project for a new LIMS can have serious consequences for the whole business. Selection of LIMS, however, is still often seen as the preserve of the laboratory itself and responsibility for its selection and implementation is given to the Laboratory Manager and their staff.

Understandably, laboratory staff often employ the same techniques in selecting a LIMS as they would for selecting laboratory instruments. Typically, this means that their requirements of a LIMS are identified by producing a Request for Proposal (RFP) or Invitation to Tender (ITT) document. A choice of system is then made based upon the replies to these documents, along with a demonstration of the system.

If the functions of commercially available LIMS products are listed, they can all seem (and are) quite similar. New features introduced by one supplier will very quickly be adopted and introduced by others if they are worthwhile. Furthermore, if the relationship between the CRO and the LIMS supplier is good, it should be possible to exert influence on the future development of the product. With this basic similarity in mind, it is unfortunate that some potential CRO users of LIMS focus solely on technical functionality in their system selection, ignoring other equally or more important issues around system implementation and the relationship between the client and supplier.

Service requirements and capability, whether direct from the supplier or a third party, are often left to the end of the decision process. Sometimes the CRO has no knowledge of the experience, competence or quality of the service organization that will implement the LIMS prior to the Project Initiation phase. By then, it is probably too late and what should be a close business relationship based on maximizing the benefits of the system for the CRO becomes a question of implementing software 'bells and whistles'. The question 'does the system meet the business needs of the organization?' is very different from 'does the system contain all the functionality that was originally identified?' The former being very much more important than the latter.

THE HUMAN ELEMENT
What is really being said here is that a large scale LIMS implementation project is about people, not technology. From the end users operating a system which supports the way they work through to mapping the system to the organization's high level business processes, the 'human element' is key. It is vital that both the client and supplier understand that, when working with people on a large scale project, they are dealing with issues of fear of change, change of culture, change of working practices and other legacy issues.

LIMS suppliers are becoming aware of the value of their experience in a client's project and specifically their skills in ensuring project success. Enlightened suppliers know that a project's failure can reflect on them globally, and must therefore be keen to see the client's project all the way through to success. Technology can help to solve many problems but only if firstly the problem is known, & secondly, how to solve it.

- The author is currently Project Director for the implementation of a CRM solution at Thermo LabSystems