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The ‘de-verticalization’ of drug development activities is a clear and well-documented trend in the life sciences industry. Companies are increasingly working with a host of external partners, including: academic laboratories and large non-profit research institutions for scientific innovation; partner companies for complementary research and drug development capability; and contract research organizations (CROs) for efficient and cost-effective large scale synthesis, screening, and characterization of chemical and biological materials.
“Cloud electronic laboratory notebooks (ELNs) have been increasing in popularity as they allow for efficient and secure sharing of research information”
The industry is not only becoming ‘de-verticalized’, it is also becoming globally distributed, with organizations increasingly collaborating with partners around the world, meaning that having a central, safe, easy-to-use portal for the storage, searching, analysis, and sharing of data which is key for optimizing drug discovery and development.
Cloud electronic laboratory notebooks (ELNs) have been increasing in popularity as they allow for efficient and secure sharing of research information among multiple stakeholders and collaborators in the R&D process. But not all cloud ELN systems are created equal. There are certain must-have elements of a cloud ELN system that make it the most effective tool for scientific data management and sharing available.
Based on Arxspan’s years of experience developing a cloud-based ELN platform, we have put together the following list of the key ELN workflow needs that support increasing industry collaboration, and have indicated what to look for in a cloud-based ELN system.
1. Ease of Deployment and Use
When choosing a cloud-based ELN, consideration of time, resource, and training implications should influence your decision. The system’s out-of-box deployment should take place in no more than one business day, and the client’s system administrator should be able to add new internal or external users within minutes.
The system should be platform agnostic, operating efficiently across PCs and Macs, desktops, laptops, tablets, iPads, and smart phones as well as be intuitive, easy-to-use, and fast to set-up, for the ultimate user convenience. System maintenance and updates should be performed remotely by the hosting company, and there should never be any need for an onsite visit to perform any service.
With the cloud system, there should be no versioning of software, as the production version of the system should be the latest and only version available. Any enhancements to the system should benefit all users immediately. Although, English is a commonplace scientific language spoken globally, the system should have language localization to other important regions of the world, such as Japan and China – this is especially important because of the high volume of pharmaceutical activity in Japan, as well as the extensive pharmaceutical CRO service activity in China.
2. Legal and Regulatory Compliance
With multiple data inputs to a system from various stakeholders, it becomes important to track and record who has ownership of what experiments, who has inputted what data, and when specifically the data was inputted. Experiments should be owned only by one person, and clear audit/version control should be in place to track and time/date stamp experimental work, for the purposes of regulatory and intellectual property tracking.
The system should thus have the capability to store read-only previous versions of experiments, with indications of the last action performed on the experiment: experiment creation, saving, signing, rejecting, witnessing, closing, and more. The notebook should have signature and witnessing capability, with two factor authentication capability for user identity verification.
Experiment audit trails and digital signatures are important components of 21 CFR Part 11 compliance, and good cloud-based ELN systems should be at a minimum 21 CFR Part 11 qualified for these functions, , ensuring equivalency to paper records. Better ELN systems are suitable for GxP environments, whereby the system can be easily validated by the client to ensure adherence to strict standard operating procedures and scientific workflows. Best of all is an ELN system that is HIPAA-compliant, allowing storage and management of clinical data.
3. Sharing of Experimental Data
Many ELNs on the market are effective at managing internal scientific workflows, but fall far short when it comes to collaboration with external parties. Flexible, permission-based sharing of notebooks and projects, not only with internal research team members, but with outside partners, vendors, and collaborators, should be a standard feature of any good ELN system.
Authorized users should be able to add or remove collaborators from notebooks or projects instantaneously. It should be easy to give recipients access to a notebook or project with read-only, write-only, or read-write privileges. The system should also have the capability of having permission trees set up to facilitate data oversight and sharing.
The system should have the flexibility to add, delete, or deactivate users with the click of a button, enabling short and medium term engagements between clients and their CROs and other collaborators. If a user is deleted from the system, their legacy data should remain in the system and be accessible by people with the required access privileges.
4. Integration with Existing Legacy Systems
The hosting company should have proven experience of connecting to client data contained in in-house legacy ELNs, inventory systems, and registration systems. These systems tend to be large and expensive, and making sure that the cloud ELN solution can access and share data with them is an important factor to consider. Out of the box integration with widely deployed registration and sample management systems is a must. As an example, Sunovion Pharmaceuticals uses Arxspan’s ArxLab Notebook ELN to link outside CROs that are synthesizing and analyzing stereo-chemical compounds with their internal legacy chemical compound registration system. An inability to facilitate this kind of integration would render a cloud ELN system flawed in our view.
5. Infrastructure and Data Security
There should be no need for you as a user to house or maintain any on-premise databases or servers, and the system should be accessible via any web browser: Explorer, Firefox, Chrome, Safari, Opera, or others. It must also provide speed, especially when searching for content or structures. To meet the changing and future needs of the drug development industry, the system needs to be easily scalable, allowing for the immediate addition of large amounts of users and data.
For maximum security and flexibility, especially when you are working with multiple partners, IP address blocks should be available to restrict system access to approved IP address locations. Secure system encryption is essential, as are daily backups from the hosted data center to a qualified third-party data center. The system should also have the capability of integrating with authentication systems and VPN networks.
Constellation Pharmaceuticals previously used a client-server ELN system which they found difficult to maintain, problematic to upgrade, slow to use, and required local installation. After researching the market, the company determined that the ArxLab Notebook ELN allows straight-forward global access by all users and meets the legal and regulatory requirements required for drug discovery.
Making the smart choice
When it comes to choosing a cloud-based ELN system, it can be hard to compare suppliers and understand what features and benefits any particular system might bring to your organization. Based on the changing nature of the drug development ecosystem, with continued ‘de-verticalization’ and collaboration, we believe that any system should be future-proofed as standard in the ways outlined above. The ArxLab system has been developed on the premise that it must mimic work patterns familiar to users and securely facilitate global and collaborative scientific work input to improve data collection, clarity and evaluation, and, ultimately, play a key role in streamlining drug development.