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The unique requirements of contract research organisations (CROs) demand the deployment of sophisticated informatics systems, as Beth Harlen discovers

A recent analysis of the European contract research outsourcing market by Frost & Sullivan has found that the markets earned revenues of approximately $6.07 billion in 2011, with an estimated $11.54 billion in 2018. According to the report, phase III clinical trials account for the largest share of the total contract research organisations (CROs) market in Europe and CROs currently account for nearly two thirds of the Phase I to Phase III trials conducted globally.

‘The availability of specialised research technologies, coupled with an exclusive focus on drug development and testing, will boost the chances of success for CROs and offset the benefits of in-house R&D services,’ commented Frost & Sullivan research analyst, Deepika Pramod Chopda. ‘Strengthening outsourcing partnerships and alliances with leading pharmaceutical and biotech companies through strategic long-term contracts will also support the uptake of CRO services.’

In order to maintain a high level of service in what is an increasingly competitive market, CROs need to give careful consideration to their informatics needs. From vendors to contract research organisations, industry experts share the unique challenges of this market and the role that informatics solutions play in meeting them.

Dr Paul Pearce, CEO and founder of Nova Biologicals

'As a full-service laboratory that provides testing and consulting services to the water, medical device, pharmaceutical, neutraceutical and food industries, Nova Biologicals must comply with the regulations of the National Environmental Laboratory Accreditation Program (NELAP), the EPA and the FDA’s GLP and GMP requirements.

'Standards – especially for environmental testing laboratories – have become far more rigorous as new regulations have been introduced. This means we and our clients must perform labour-intensive procedures to ensure compliance, such as sample tracking, chain of custody (COC), record keeping, demonstration of capability (DOC), document control, reagent and standard traceability, proof of training and reporting.

'Regulatory audits are unpredictable and sporadic, so Nova’s labs must be constantly prepared to comply with an audit without creating debilitating delays. Our previous paper-based system made audits time-consuming and onerous. Now, because everything is stored in chronological order with dedicated authorised folders sorted into months and years, the whole process of auditing is much easier and records are automatically updated. Managers can also now review records weekly instead of monthly making internal auditing more efficient.

'Auditing of training  documentation is particularly key and this is where the LIMS (laboratory information management system) is invaluable, allowing automatic updating of customer training records. All standard operating procedures (SOPs) are loaded and staff member training is also recorded.

'Our biggest challenges are to automate manual and paper processes, increase sample throughput and improve efficiencies, all while enhancing customer satisfaction and ensuring compliance with the ever-growing demands of industry regulations. Meeting these needs can be hugely time consuming and expensive, especially when we also need to package and report quality control information, which is vital for sending to clients.

'Prior to implementing the Thermo Scientific SampleManager, we managed our work using paper that was supported by an outdated laboratory information system. The lab system had data limitations and deficient reporting capabilities and continued use would not sustain the growing business in microbiology, medical device and pharmaceutical testing. In addition, since the old system was located on one computer, only one employee could use the system at a time, which created bottlenecks in the lab and significantly limited the volume of samples that could be processed.

'LIMS have become much more prevalent and necessary in our testing facilities as demand and regulations have grown and paper-based systems are no longer effective. A LIMS works by scheduling and holding sampling plans, which are then used to generate a collection run for each sampler. The collection run defines where samples must be taken from, what sample bottles must be collected and what onsite tests have to be performed. Samples are then analysed in the laboratory and data, as well as details of what has been carried out in the field, is entered into LIMS. This is important as water companies must collect and analyse their water samples in a closely regulated environment, maintaining complete quality control records in case of inspection or audits.

'The nature of sample testing means that there are peaks and valleys – and some months, such as quarterly state reporting deadlines, are much busier than others. We may have as many as 1,500 Coliform samples to process in one day, and in the past it was a struggle to manage these volumes because of the limited accessibility to the legacy system. With SampleManager, as many as five people can process samples at any one time – which means that we can now process very high sample volumes in a short period of time when necessary and gives us the ability to manage sample fluctuation.

'We’ve also seen improved efficiencies, better quality and personnel cost savings. With five members of the staff being able to log samples at the same time, staff bottlenecks have been eliminated, saving many man-hours across the company. In addition, significant improvements in efficiencies and data quality have been achieved with the systems automation, built-in document management capabilities and report generation and distribution functionality.

'We’ve also seen improved customer service and our responsiveness time has improved. SampleManager enables us to provide our clients with more meaningful information and data. For example, reporting on sample trends, patterns and volumes is something we have always been keen to do, but is now greatly facilitated by SampleManager’s ease of access to information. This adds commercial opportunities to our portfolio as we can tailor reports to individual customer requirements, offering a bespoke reporting format to a wider customer base.

'Finally, we’ve been able to reduce our reliance on manual and paper-based processes. The LIMS has helped us to significantly reduce the amount of paperwork used in its processes and methodologies. It has automated and accelerated processes within the company from sample collection to results and report generation, saving time and reducing costs through improved production efficiencies. The solution has helped to eliminate manual error-prone processes, improve data quality and save substantial amounts of time. Furthermore, secure access to sample data is available for laboratory staff, remote users and external customers, enabling all system users to view the same information and ensuring consistency and clarity.' 

Dominic Farmer, CEO of Cisiv

'Contract research organisations (CROs) have to be at the forefront of the pharmaceutical market when it comes to technology. They have to meet the needs of their customers when it comes to providing research services, but they also have to think about the impact on the investigators that are actually running their studies for them.

'At the same time, the need for clinical research is changing as the wider pharmaceutical market evolves. While the number of drugs going through clinical trials may be falling, the number of treatments that are being reclassified or used in different markets is going up. This means that CROs are increasingly being called on to run non-interventional studies rather than clinical trials.

'Non-interventional studies are different beasts to clinical trials. Rather than the strict rules of the clinical trial, non-interventional studies track real-world interactions between doctors and patients around treatments. These studies can be used to support drug re-classification, for example when a cancer treatment can be used to meet a new oncology requirement, or for pharmacovigilance purposes.

'From a technology perspective, CROs have to date been using standard clinical trials electronic data capture (EDC) for their non-interventional studies. This approach has been driven by client requests, i.e. we want you to use a specific clinical trial solution as that is what we are familiar with, or because they are not aware of more focused solutions for non-interventional EDC.

'The problem is that these EDC technologies are often difficult for the investigators to use in a non-interventional study context. They are designed around a different class of data collection rules than those that apply to non-interventional work, for example. Clinical trial solutions also concentrate on a less dispersed model: a higher concentration of patients per centre and, overall, a lower number of patients. Lastly, clinical trial software has not been developed to meet a need for localisation into multiple languages and for different healthcare compliance rule-sets.

'While it is possible to re-use clinical trial software for non-interventional studies, this may lead to problems for the CRO in the longer term. A key consideration will be around investigator retention, as a technology designed for one purpose is being used for a different application. As it is more difficult to enter data, the churn rate for investigators increases as frustration mounts up.  In turn, this increases the cost to run and manage the study and potentially lowers data quality. For the pharmaceutical company sponsoring a study, this becomes an issue if the data quality is not high enough to be relevant, or studies don’t produce the required set of results for analysis. It’s also an issue for the CRO as their business depends on supplying the research information that will meet the pharma company’s requirements. From being a technology pain point, it becomes a business issue as well.

'Non-interventional studies need a different approach to data management that is less focused on data items and uses different methods to measure and manage overall data quality. New methodologies are needed to manage data as it is collected in very different ways. In essence, these methodologies are embedded in new technologies built specifically to focus on the problems that exist around real-world EDC and study management.

'As the need for this real-world data increases and more studies are undertaken, CROs will have to expand their awareness of what these studies are designed to achieve and how their informatics solutions can help deliver this. CROs will take the lead in expanding how these valuable sources of data are compiled and delivered to their customers, but they also need to embrace what makes the non-interventional study different: the emphasis on the real world, rather than the clinical.'

Chris Molloy, VP corporate development at IDBS

'As data is the product of the relationship between CRO and customer, data management becomes one of the most critical issues. The unique perspective that CROs have on the informatics space is that they are often working for multiple parties across their business. This leads to a number of different requirements including the maintaining of security between projects, adaptation to varying ontologies and data standards, and the financial incentives of reporting that data quickly and effectively. The implementation of data management software along with domain process modules allows CROs to become much more efficient, reducing the time to reportable data. Security provisions are also crucial in eliminating the potential for data cross contamination.

'Historically, communication of data has been very document-centric. It has been the movement of PDFs or spreadsheets, or even PowerPoint files, but the passing of these structured or unstructured documents actually causes a break in the flow of information. This is because the lack of sufficient context reduces insight into the quality or provenance of the data. The solution is to open up a data channel that provides the customer with secure, right-time access to the data that is captured with context. This enables customers to have faster results, to be able to look into their CROs’ processes and identify the stage their work is at, and question the data environment. In addition, it allows customers to better challenge scientifically the data being generated, building trust for all parties.

'Of course, this approach needs an informatics system with sufficient granular security to make sure that any given customer can only see and query their own data. Single log-on systems are simply not able to support the complex multi-customer environments of CROs and they have suffered in the past from being asked to use multiple systems. The movement towards multi-party solutions with granular security therefore provides improved efficiency on both sides.'

Ian Berry, manager, informatics at Evotec

'As a drug discovery solutions provider to the pharmaceutical industry, the biggest challenge by far is data exchange. Efficiently and securely transferring data from our systems into the clients’ systems is made more difficult when the requirements of one client differ greatly to those of another. As a result, we have been looking at implementing more lean processes and trying to make them as efficient as possible internally, while maintaining that key point where we can diversify based on client needs. Rather than being in the situation where every single stage is bespoke to the client, such as having the project database set up in a very specific way, we’re trying to harmonise the structure so that it is only when we are exporting data that the differentiation comes in. Having that consistency of internal processes also means that, when our chemists or biologists move between different projects, they don’t need to spend time familiarising themselves with their new project’s working practices.

'In terms of introducing new informatics solutions, we are just about to go live with a project tracking and data management solution for use by project teams and our DMPK (Drug Metabolism and Pharmacokinetics) group from The Edge Software Consultancy. BioRails PTO allows our project teams to submit requests for assays and track their progress. It queues requests from multiple clients so they can be efficiently processed by the DMPK group. BioRails DM and Morphit provide all the data management and data analysis capabilities they need respectively.

'Morphit, a flexible Excel-like front end, allows us to process and analyse the data working seamlessly with the data management system to store all the data in our database. It allows us to consolidate results and selectively provide them to the right clients in the required format. On our chemistry side, we use ChemAxon’s JChem suite of tools to provide cheminformatics functionality. Our ELN, iLabber from Accelrys, is deployed across all domains and the feedback we have from chemists is that it’s simple and allows them to record their experiments effectively, while our biologists like it because they can treat it just like a paper notebook. The only difference is that it’s in an electronic format, which allows users to embed Excel files.'

Thomas Rozlucki, MD of Contur, 
a wholly-owned subsidiary of Accelrys

'In the past five years, the business model within the pharmaceutical industry has transitioned from a focus on internal resources, to where partners are being used to a far greater extent. In many cases, CROs are small organisations with limited budgets, but which face the same challenges as their larger counterparts, such as protection of their or their customers’ IP, the internal and external sharing of data, and the need to boost productivity. With regards to informatics, these are similar to the needs of any user, but what makes CROs unique is that need to cross organisational boundaries.

'Historically, there haven’t been any solutions tailored to this that would enable everyone in this eco system to feel comfortable and confident about security and data integrity. There is also the question of who should pay for these solutions. In some cases, the CRO will make the investment so that internal systems will store knowledge in a centralised fashion. Many don’t have that solid foundation, but if a CRO is serious about being a partner to pharma or biotech companies, they need to think carefully about data management and how to build that internal knowledge vault. Informatics platforms are a key part of this and CROs should work with vendors who can assess their needs and who truly understand the nature of these collaborations.'

Rudy Potenzone, VP of product strategy, informatics, PerkinElmer

'With the recent changes in the pharmaceutical industry, CROs have become a key piece of the drug development cycle. Virtually every company is now using CROs for core research work, from the more regimented synthesis of compounds to the executing of screens. The driver has largely been to reduce costs, but it has also given pharma companies the opportunity to find unique skill sets.

'The provision for bringing in an internal group is very difficult; it takes time. CROs therefore provide a level of flexibility to get the work done without being a drain on resources after the project ends. The downside, however, is the host of issues that arise when bringing an external group into the mix of developing compounds – time-zone and communication issues, and the challenge of keeping the team activity at the most efficient level, to name a few.

'This is where the ability to use common data systems is a must. It’s important for the CRO to specify the types of experiments that are to be executed, whether there are agreed protocols, and then use informatics tools to gather that information and move it to the pharma company in a more complete fashion. Having the experimental record is important and informatics systems have a significant role. There will always be complications when you have people outside your corporate firewall and, in terms of both speed and capacity, the internet is not standardised around the world. Often, our customers are providing licensces directly to their CROs, ensuring the data collection and reporting is the same across their projects within our ELN framework, and each company may use different technical strategies to solve firewall access.

'But this does lead to the challenge of training. Often companies will set up contracts with their CROs to provide the software tools they wish them to use and ensure they are fully trained. Of course, this all comes down to the decision of how tightly the integration between CRO and pharma is to be. The key point is to ensure that all the necessary tools are there and that there is a clear plan of how much of the context, such as experimental conditions, can be specified sufficiently when the results are transmitted.'

Nick Townsend, director of life sciences at LabWare

'Having the right solution can enable CROs to respond quickly to the terms and conditions set out by new contracts, and demonstrate that they are adaptable to changing requirements. Every lab wants a flexible system, but with CROs it’s the life blood and letting clients know that samples can be handled in a certain way or reports delivered in a specific format personalises the service and could mean the difference between winning a contract and not. This inevitably means adapting the LIMS or ELN to the individual requirements of the client.

'There are essentially three types of lab informatics system. First are those that are designed for a specific application. They do what they do and nothing more; so-called non-configurable products. Then there are systems where the software is completely customised and while that leaves the customer with a solution that is unique to them, it does make it difficult to upgrade and support. In the middle of these two are standard off-the-shelf LIMS that have the ability to add client-specific configuration in order to adapt to fluctuating needs without altering or compromising the core product. LabWare LIMS and ELN fall into this category.

'CROs can also benefit from a degree of CRM (client relationship management) capability in the software, especially as projects develop over time. Solutions like our LIMS can operate on a commercial level by assessing work, issuing quotes, and tracking all associated costs.'

Stephen Gallagher, 
CEO of Dotmatics

'Compared to any other lab environment, CROs are strangely very similar, but very different at the same time – and those differences can be quite subtle. CROs are incredibly particular about what they spend money on, as more software often means fewer bench scientists. Informatics tools need to provide a big efficiency boost in order to be worthwhile, and before even considering the external interaction with customers, CROs need to examine their internal data structures.

'A large pharmaceutical or biotech company will have what I like to call Armadillo security – a very hard exterior, but a soft centre that enables people, and data, to move about freely. With a CRO, the challenge is to make it easy enough for staff to jump between projects if necessary, but within very rigid security parameters. This is compounded even more when CROs want to make that system available to their customers.

'In the past, CROs wanted to replicate the operating procedures of biotech or pharma companies, but over the years that has become much more sophisticated and CROs now want to allow customers to dynamically search, collaborate and make requests. These are fairly simple ideas, but making them work well in a collaborative environment is difficult. Workflows are becoming more of a talking point as companies get away from file-based results and communication and move towards live data that can be interacted with. The days of emailing PDFs of results are slowly coming to an end and there are various informatics solutions suited to this change (including ours).

'Thin-client applications, such as our web-based ELN, provide rich, flexible tools, and with a lower cost. With our ELN, users simply open a browser, connect to a URL and access the data. The integration of a query tool also emphasises that sharing of information and when clicking on a compound, users can see the generated data, regardless of where it originated. This is incredibly beneficial in collaborative environments.'