At a Contract Research Organisation (CRO), there is a double pressure on sample management. You are often looking after other companies’ samples as well as your own, and may also be relied upon to screen these as well as your own library – in an efficient, traceable and auditable fashion.
Why is sample management different for CROs?
CROs have to face an exhaustive selection process when drug discovery companies are choosing a CRO partner to match their needs. Value, or cost of services, is always a consideration but it is by no means the only criteria. Offering the competency of a big pharma compound management department can be more important. Collaboration, transparency and responsiveness also feature high on the list of things companies look for when assessing CRO services.
As a result, sample management at CROs is not just about sample security and traceability. CROs need to get their sample management processes exactly right in order to meet the needs of many different sizes of company across biotech as well as pharma. To do this, they will need to blend lab automation, specialist software, security and reporting into one seamless system that is quick to get up and running and can respond to process changes.
The following are essential criteria for sample management solutions at CROs:
- Sample tracking and access control – both of these need to be securely managed to maintain confidentiality and traceability across different CRO customers
- Communication – this ensures work is transparent and progress is automatically reported, but only to the right teams
- Efficiency – CROs rely on optimised automated and manual workflows, pre-validated processes and operator guidance to easily manage multiple workstations in order to meet customers’ SLAs and provide a cost-effective service
- Robustness, error management and recovery – at a CRO, everything is about reliability and minimising errors in order to provide a good service for clients
- Compliance – every sample preparation step needs to be tracked automatically via a 21 CFR Part 11 compliant audit trail, that records who, what and when
- Flexibility – many CROs need to manage a wide breadth of processes and sample types to accommodate clients’ needs
This list of requirements is both broad and complex, so it is difficult to meet either in house, or through one system provider. However, CROs need their processes to be up and running quickly and reliably, without a heavy IT or development burden. How can these different demands be reconciled?
Fortunately, because efficient sample management underpins so much of the drug discovery process, there are tried and tested commercial solutions available. In several cases, vendor partnerships ensure that different best-in-class systems can be integrated off-the-shelf to meet even the demanding needs of a CRO. As vendors develop their systems and collaborations to match market pressures, these integrations are updated and improved.
One such is Titian Software’s Mosaic sample management LIMS. This has a wide array of vendor partnerships already in place, so that Mosaic can act as an integration hub for many types of lab automation (liquid handlers, scanners, automated stores, and so on) as well as commonly used registration and data analysis software.
System integration can deliver efficiency and data integrity
CROs need to minimise system implementation lead time to be able to keep their costs down. One approach is to request that all chosen sub-systems from vendors should have established integration requiring minimal development work, as development is expensive to resource there is the risk of incurring delivery and testing delays.
Well integrated systems produce greater efficiencies, partly by improved scheduling and smooth processing, but also by eliminating human errors.
“The important thing about Mosaic for us is the fact that it allows us to maintain data integrity. It bypasses the need for human intervention so there should be no errors” says Denise Swift, Senior Scientist at Sygnature Discovery
For instance: Titian’s Mosaic sample management software can be used to link a registration system, automated stores, liquid handling and data analysis software into one managed system, as at Sygnature Discovery. This has many benefits, including:
- Samples are tracked from end to end of the workflow
- Data is passed automatically to where it is needed, without manual file handling
- A complete audit trail is automatically logged
- Sample processing is error free as scripts are automatically written by Mosaic, avoiding time consuming programming and human errors
- Error handling and recovery is improved, ensuring that what can be processed is processed
For many CROs, combining similar elements into one managed system is the key to delivering efficiency.
David Cronk, Director of HTS Sciences at Charles River, says: “We have a number of other data management tools within the organisation, there’s the chemical registration system which Titian Mosaic directly interfaces with. From a screening data perspective we use ActivityBase from IDBS and Genedata Screener software and we have interfaces that link all those packages together to track the samples.”
Seamless customer communication is essential
CRO companies are increasingly finding that their clients, who have their own LIMS platforms, want to tie these into the CRO’s services to allow their scientific project team to request substances with real time feedback on availability, even though stocks are held externally . This means that, for a CRO, it can be important to use sample management software that either matches, or is easily compatible with, that used by their clients.
CROs are saying it is increasingly essential for clients to know where they are in the pathway, what work has been performed and to access the data as fast as possible. This digital communication needs to be made easy between teams at different companies – but still maintain tight security and confidentiality.
Because this communication is essential, Titian is completing a Partner Portal in its Mosaic sample management software. Customers can connect to the Mosaic Partner Portal through any web browser and from there can access pages allowed by the CRO. These include: simple ordering, inventory viewing and canned queries. More details of the Partner Portal are available on our CRO page.
As well as the Partner Portal, Titian also offer a Connector for when both the CRO and customer(s) are already using Mosaic. The Connector allows the customer to create and submit orders on their own system, but for the CRO to be able to fulfil the orders. An example between GSK and Evotec is detailed in a recent poster.
Integrated automation helps to deliver
Essential to many of the benefits that a CRO wants to see in a sample management system is integrated workflows based on automation. Automation provides both throughput and error-free processing, but the data produced by each automated system needs to be reliably fed into the larger workflow. This will ensure robust QC data and an audit trail that can trace anomalies back to an individual pipetting error or number of freeze/thaw cycles, if needed.
Seamless integration with robust sample management software can manage automation, registration and analysis into one smooth, end to end system that tracks each sample through its life cycle.
The ultimate in sample management systems?
In summary, a CRO will be looking for the ultimate in sample management systems because of its double responsibility: both to its own processes and to its customers. This is true whether the CRO focusses on providing compound management or screening services. Such a system needs to combine robustness, efficiency, traceability, transparency, integration and security.
Many CROs have chosen Titian’s Mosaic software because it is well known and trusted in the pharma industry. It provides a CRO with a guarantee of process quality, as well as comprehensive inventory management and a full audit trail. It also offers easy integration with other LIMS to provide transparent digital communication and process updates to their customers. For our CRO customers, Titian's Mosaic has resolved complex upgrade issues, provided flexible evolution, brought data integrity and streamlined processes, while providing excellent support.
Want to know more?
Discover the sample management benefits Mosaic brings to CROs on our CRO web page
Download our case study of CRO Sygnature Discovery
Or contact us to discuss your particular needs