All part of the service
The complexities of drug discovery and development and the competitiveness of the pharmaceutical market have led to a work ethos where outsourcing is becoming more important. A pharmaceutical company has to be competent in such a diverse range of fields, from analytical chemistry to manufacturing and marketing, that outsourcing aspects of its work to contract research organisations (CROs) and other service organisations provides advantages in terms of the expertise these organisations offer.
CROs can vary in size and complexity, with some offering specific services, such as Apredica, which provides preclinical ADME (absorption, distribution, metabolism, and excretion) toxicology assessment, and others offering a more broad range of research services, enabling pharmaceutical companies to outsource almost an entire phase of a project to them.
As Trish Meek, director of product strategy for life sciences and informatics at Thermo Fisher Scientific, points out, CROs need to operate at very low margins to deliver competitive pricing while providing good value for money. Therefore, efficient laboratory operations are crucial. Furthermore, ‘since information is the CRO’s product, management of that information is at the core of their business,’ she continues. Laboratory information management systems (LIMS) and other data management software are often a key part of maintaining efficient laboratory services.
The customer is always right
Any organisation contracted to work on behalf of other parties has to have the wishes of its clients in mind, and CROs are no different. What is generally required from laboratory information systems is the flexibility to respond quickly to new contracts while meeting the ever-changing demands of existing customers. ‘A client might have a list of requirements that a CRO has to meet in order to win that contract,’ explains Nick Townsend, director of life sciences at LabWare Europe, ‘and therefore the more flexible the LIMS software is, the more readily the CRO will be able to commit to the client’s conditions.’ LabWare provides LIMS solutions to a range of industries, including pharma and CROs.
Simply by their nature, CROs will organise data on a project basis and LIMS will often be required to encapsulate all the data associated with a particular project. At some point, the CRO might want to archive and remove from the system or return to the client all the data associated with a particular project. The CRO might also want to restrict certain staff to certain projects. Some of these traits are required in mainstream pharma, says Townsend, but he feels it is more pronounced with CROs.
Tom Curtis, vice president of product innovation at Ontario-based Labtronics, says that, in terms of data management, CROs have an extra challenge over pharmaceutical companies, in that a pharma company will have defined a specific set of informatics needs. These might be modified over time but will tend to have a set core: ‘The challenge for the CRO is that it will have to deliver information that matches the informatics needs of each of their different clients while retaining their own core informatics setup.’
Being able to handle data from multiple clients each of which could have multiple contracts requires a robust data management system. The University of Guelph’s Laboratory Services Division in Ontario, Canada, while not strictly a CRO, conducts analytical work on a contract basis and has been running Sapphire LIMS from LabVantage since 2001. ‘As a contract laboratory we have thousands of clients, many with unique requirements in terms of how they want to see data presented,’ states Lori Gray, director of business operations at the University’s Laboratory Services Division.
The laboratory receives huge amounts of information from different clients, which is not important for analytical testing per se, but is important for the client’s research or product development activities. ‘We find ourselves not only managing our own data, but also our clients’ data,’ Gray says. Sapphire LIMS stores any additional information related to the samples, which are then sent with the test results in the requested format – ‘this is the added value we’re able to provide through the LIMS platform,’ she says.
The university maintains large amounts of data in its LIMS; the animal health surveillance programme for the Ontario Ministry of Agriculture, Food and Rural Affairs, for example, is stored in the LIMS, including historical information related to large animal practices and animal disease surveillance, as well as data collected during the programme. This data enables the ministry to identify areas of investigation for disease outbreaks, for instance. ‘The government is counting on us for its disease surveillance programme, whether that’s through collecting data (both historical and current), analysing the data or calculating results,’ comments Dawn Van Dam, director of marketing and sales at the university’s laboratory services division. ‘It’s a significant role we play in this regard,’ she says.
The ministry is linked into the university laboratory’s LIMS through Sapphire’s virtual user licence, a licensing scheme granting secure access for users to view data. This not only provides a secure portal to view results, but is also used for carrying out checks and audits on the ministry’s submissions. ‘It is very important to ensure the system is not only usable by us, but can also be viewed by external customers,’ says Van Dam. ‘This system enables us to provide more value-added services and actually become an integral part of the data management and information systems of our clients.’ In addition to simply viewing the data, there are a number of clients linking their systems into the university’s to enable transfer of data, allowing the client to populate its own systems from data in the university’s LIMS.
Andrew Lemon, managing director at The Edge Software Consultancy, believes these portal-based approaches for sharing data are becoming more important in this type of environment. Web-based workspaces, such as Microsoft SharePoint, are one of the methods for secure data sharing available to CROs.
The labs at Debbiom, a company that manages and performs high-quality bioequivalence studies for pharmaceutical companies.
Being able to share data is generally either via a secure window into the CRO’s system or through an externally facilitated portal where data can be exchanged. The Edge Software Consultancy, based in Guildford, UK, provides web-based data management solutions, among other services, to the pharmaceutical and biotechnology industry. Its BioRails Cascade product is a request fulfilment and workflow solution, allowing a CRO effectively to plug in an external service into its internal system for managing its incoming requests.
Generally, data generated by a CRO is first worked up, quality-checked and validated before the final results are released. BioRails provides a state flow on the data, allowing pharmaceutical companies to monitor the state changes as they occur without providing access to the live data before the results have been validated and published. Once they are published, though, the raw data is shown. BioRails is built on the Ruby on Rails framework, which is good for high-volume, constant-access data systems.
Speaking the same language
One of the challenges that Ian Berry, principal software developer at Evotec, identifies is getting everyone to talk in the same language. ‘Each client will ask for their results in their own format, often changing what they want to see,’ he says, ‘and much time is spent making minor formatting adjustments to export options for each individual client.’
Evotec is a CRO involved principally in the discovery and development of novel small molecule drugs. Berry feels that, in an ideal world, what is needed is a common format for data transfer. With a common language for communication, it wouldn’t matter how a compound structure is stored in internal databases, either by the CRO or its client, because there is a common format by which it can be transferred. This would allow both parties to view the data, irrespective of how they store it internally.
The Pistoia Alliance, a not-for-profit organisation set up by various pharmaceutical companies including GSK, Pfizer, and AstraZeneca, is trying to go down this route. It aims to develop data standards at a non-competitive technical level in an effort to streamline the drug discovery process. The development of these standards will be beneficial for the big pharmaceutical companies as well as CROs, as each can store the information in their own internal format while exporting it in the common, vendor-independent format. The current priority for the Pistoia Alliance is to develop ways of querying between different vendors’ ELN systems.
Data management within Evotec is coordinated through a small e-science team, which develops software internally, including systems for compound registration, compound sourcing, physicochemical property prediction and library design. All these use the JChem cartridge system from ChemAxon (a provider of chemical software development platforms) for chemical searching and manipulation, as well as integrating other commercial software for additional functionality. Evotec also uses Symyx ISIS/Base, ISIS/Host and ISIS for Microsoft Excel across many of its projects, although it is moving many of its project databases to the Instant JChem system. Evotec is also in the process of implementing an ELN from Contur across the chemistry and biology sides of the business.
Instant JChem allows users to manage and work with chemical structures and related biological data using local and shared databases. Evotec hosts a version of the software on a centralised Oracle database, from which it can export a local version of the project database to distribute to clients, thus allowing them to view their data through the free version of the application (Instant JChem is free for personal use with local databases).
Berry feels that being adaptable is key to the way Evotec manages its data. ‘Internally, we have to store all the data in the same systems, and yet keep the data separate to obey strict data confidentiality rules,’ he says. ‘By developing many systems, we have greater flexibility to tailor the output to the clients’ needs and ensure that there is clear separation of the data. In most cases, we are not allowed to make the same compound for two of our clients, so our systems must ensure that we are not infringing our agreements.’
Data security is also cited as a major requirement for LIMS software by Ruben Velazquez, laboratory director at Debbiom, a bioequivalence laboratory based in Monterrey, Mexico. The company is currently implementing LabVantage’s SQL*LIMS product, which Velazquez says ‘will be a key component for providing our customers with secure and compliant data’.
Adherence to compliance and audit requirements imposed by both the client and regulatory bodies is something CROs are constantly faced with. ‘There are two goals that CROs are aiming to meet: to be very flexible and very quick at adjusting to change; and to be able to adhere to very strict compliance and regulatory requirements,’ comments Steve Bolton, marketing specialist at Labtronics. The company’s Nexxis ELN allows the CRO to adhere to regulatory requirements within a framework that allows them to upload new or updated SOPs quickly – if, for instance, the CRO is moving from a paper-based system, Nexxis ELN can transfer paper documents quickly into an electronic format without extensive background coding and other aspects associated with implementing an informatics solution.
In accordance with Berry of Evotec, one of the considerations of CRO, PRA International, for selecting a LIMS platform was being able to communicate effectively with its customers. The company with headquarters in Raleigh, North Carolina, installed Thermo Scientific Watson LIMS at its Netherlands-based bioanalytical laboratory, because many of its clients were using the system. The CRO handles 150,000 samples per annum; running a LIMS platform that’s also used by some of its customers meant that formatting variances in the data would be minimised when sending reports.
Contract organisations often require integration of data management systems with other informatics systems, and not simply laboratory instrumentation, but finance packages for invoicing and customer relationship management (CRM) platforms. LabWare LIMS provides CRM capability through its Contact Manager module, which allows the user to record names and addresses of key contacts and log interactions with the client. In this way, an audit trail of client interactions is kept throughout the course of a project. ‘This wouldn’t be a particular requirement for a pharmaceutical company but it certainly is for a CRO,’ states LabWare’s Townsend.
In addition to analytical staff keeping track of client interactions for the purposes of new or modified analysis requests, for instance, the CRO will have a sales team canvassing for new work, which will have a requirement for CRM capabilities.
But it is the flexibility of the system that Gray of The University of Guelph’s laboratory services division emphasises as being particularly important for contract work: ‘Some clients will send a single sample every six months, whereas another can send up to a million samples over a three month period. The laboratories have to be flexible to accommodate this and one of the benefits of Sapphire LIMS is its ease-of-use for the IT department – the majority of changes can be made in-house without the need for external programming.’
Since the university’s laboratory services division implemented LIMS in 2001, Gray says the amount of contract work it has undertaken has increased significantly. ‘We would not be able to do what we’re doing now with the paper-based systems and stand alone in-house systems individual labs had developed prior to implementing Sapphire LIMS,’ she says. ‘Sapphire LIMS allows us to carry out cross-lab testing, to track and report everything we test, and is the backbone of our business.’
With cost pressures continuing to exert an influence on the pharmaceutical industry, partnering with and outsourcing project work to CROs is a trend that is likely to grow. Efficient laboratory practices with the ability to adapt quickly to a customer’s needs ensure contract organisations remain competitive and data management solutions continue to play a role in improving these efficiencies.