Wes Childs, senior director for engineering at IDBS, highlights how the cloud can help organisations accelerate drug discovery
For any R&D life sciences firm, establishing a reputation for accelerating drug discovery in a cost-effective manner is vital.
Many organisations are already using data gathering tools – such as electronic laboratory notebooks (ELNs) and laboratory information management systems (LIMS) – to accelerate their processes. But simply investing in the latest and greatest informatics technologies, without a wider business strategy, isn’t enough.
Global organisations often work from siloed, disparate laboratories, using siloed, disparate technologies. An advanced informatics infrastructure that integrates all the systems involved in the gathering and recording of data is the most effective method of streamlining processes and accelerating drug discovery. To enable this, organisations are increasingly moving systems to the cloud.
Below, I explain some of the benefits of a cloud-based platform for laboratory informatics.
Navigating the data deluge without compromising on quality
Data is the most valuable asset for R&D organisations. And every second of every day, more data is being produced in laboratories. The challenge for businesses is finding the best way to manage all this data efficiently, while also finding a way to unlock its true value.
With the right provider, the cloud can provide a system that automatically records all data associated with an experiment through direct data capture (DDC), removing the need to transfer data between different platforms and duplicate data manually.
DDC is particularly useful for good practice (GxP) environments, where it can eliminate paper and enable remote monitoring, allowing for immediate completeness checks. Along with streamlining data management, this reduces the chance of costly human errors, enhances reliability of the data and enforces compliance, all while reducing cost and resources required Capitalising on collaboration External collaborations are on the rise in R&D. Contract research organisations (CROs), joint ventures, academic partnerships, consortiums and other protagonists work together on a daily basis, causing all kinds of logistical problems – as various parties try to co-ordinate activities and transfer data and reports.
There’s also likely to be someone in each organisation tasked with processing these documents and ensuring they are distributed to each relevant corporate repository. It’s a time-consuming process which introduces the opportunity for data loss and corruption through human error.
Although data quality should always be the priority, there’s an often-overlooked aspect that organisations must always be mindful of when collaborating: how to adequately manage their external partners. Imagine collaborating on an important project with an external team in another country. How do you know if a study has been started? Have samples been received? Is the report ready for review?
When working with external collaborators, businesses need clear oversight on who is doing what, and when. By using a cloud platform, organisations can take advantage of built-in mechanisms for document and data review, social commenting and task alerts, meaning they can always be confident they have the full picture – even when collaboration partners are working from the other side of the world.
Facilitating good practice environments
GxP software solutions are an important tool in drug research and drug development – and the cloud is changing GxP possibilities for R&D organisations, taking the pain out of validation and offering a range of potential benefits.
With a GxP environment in the cloud, businesses can significantly reduce the time and cost to get up and running with a traditional on-premise regulated system – putting themselves in a more comfortable position for decision making and risk management.
Cloud environments can be both fully validated and 21 CFR Part 11 compliant, allowing organisations to take advantage of fully-managed documentation trails. With a cloud-based GxP solution, organisations can streamline important certification processes for regulatory bodies by providing a robust validation package alongside good audit trails, allowing audit questions to be answered and resolved promptly and accurately.
The burden of managing system validation can also be partially or wholly automated by a software vendor, ensuring software is validated against known outputs, and installation qualification (IQ) and operational qualification (OQ) scripts can be provided as part of a cloud-provider’s service, saving time and money.
Enhancing data security
Although security is often the barrier preventing businesses adopting cloud software, these concerns are frequently misplaced. An organisation’s data is often more secure in a cloud solution than on-premise.
IT personnel will naturally be cautious about moving information security outside of the enterprise walls, but mindsets are starting to change in R&D, and for good reason: cloud solution providers can often ensure a much higher level of security than standard enterprise IT infrastructure.
Organisations working with cloud providers (and ultimately their provider’s partners) are likely to benefit from best-in-class security arrangements at datacentres from some of the most trusted names in world business, such as Amazon. Such robust – and expensive – security provisions are out of reach for most organisations choosing to host their data in-house.
With traditional database software, the process of backing up data on a weekly basis can be laborious. Cloud solutions can eradicate this painstaking, essential task, scheduling automatic backups without user intervention and ensuring integrity and security of your data.
Current best practice for software as a service (SaaS) data infrastructures is to have two separate geographical locations that identically store and mirror your data. In the incredibly unlikely event that a disaster occurs in one of the centres, the other datacentre can continue delivering the SaaS service without interruption or loss of data. Very few organisations can do this on-premise.
Reducing the strain on IT teams
With a cloud solution, upgrades and the global infrastructure that runs the cloud can be looked after by a partner and their web services provider, shifting the burden from IT teams.
Neither users nor IT departments have to worry about maintenance of hardware, or which operating system version supports which databases. And organisations don’t need to invest further in costly on-premise infrastructure. All initial investment on licenses, hardware, databases and IT specialists are managed externally. The most complicated thing IT teams have to look after is often just ‘passwords’!
Thinking about the bigger picture
The price of bringing new drugs to market has increased in recent years, with estimates putting the cost as high as $1bn. In this kind of landscape, it’s only natural for R&D laboratories to turn to new laboratory informatics technologies, as they look to curb spending and bring important new drugs to market, faster.
But reducing costs should never need to mean ‘cutting corners’, especially if an organisation is looking to implement a GxP solution. The cloud can provide a secure, online platform, which complies with regulations and can be up and running quicker than a traditional on-premise environment.
The many benefits of the cloud combine to make a real, tangible difference for businesses – and with organisations investing in more technology, the cost of getting that investment right, and reducing time to value, can be truly transformative.
