We will no doubt be learning lessons from the pandemic for many years to come but two takeaways are already evident with regards to pharmaceutical data management.
Firstly, in the pharmaceutical industry collaboration is now the norm. Pfizer/BioNTech, AstraZeneca/Oxford University, the successful partnerships that have driven the development of vaccines are household names. The pharmaceutical industry has become a web of interdependent organizations, each with their own unique expert core competencies.
Secondly, the pharmaceutical industry has needed to keep essential lab and office operations open, however the ability to access information remotely has become increasingly challenging as researchers endeavor to progress under changed and challenging circumstances.
Against this backdrop there is an emerging role for electronic lab notebooks (ELNs) and cloud-based data management systems in this interconnected industry, where information flow directly impacts the rate of progress.
Pharmaceutical Data Management: Collaborating Productively
Outsourcing activities from drug discovery through to clinical trials and manufacturing intensifies the need for good project management. The splintering of the pharmaceutical industry into smaller, focused groups, notably contract research organizations (CROs), encourages specialization, and enhances agility. However, effective collaboration calls for seamless information flow between organizations of different scale working with different levels of in-house resources and a range of data management systems. Additionally, collaborators may be working in different time zones or in many cases continents.
At a time when travel and meetings are significantly curtailed, and allowable in-person activity levels vary from country to country, being able to work productively and securely with a dynamic network of partners is crucial.
Using an ELN for CRO management means that all the inputs and outputs associated with a project are recorded and stored, in real-time, in a consistent searchable form. For the project manager it offers a single interface, from which to instigate work and curate results. Using an ELN integrated within a cloud-based information management system makes it easy to communicate with partners, to instigate projects, check on progress, assign new work effectively and flag an issue. It gathers all experimental data in one place and stores it securely, providing all the information associated with a synthesis, experiment, or assay. New materials can easily be registered, and the material inventory is always up to date.
By allowing every contributor access to the information they need, an ELN system can boost the effectiveness of a whole network. Equally importantly it establishes the end-to-end information chains required to comply with regulatory standards and safeguard the commercial value of intellectual property.
Pharmaceutical Data Management: Access and Security
Modern ELNs and cloud-based data management systems operate on a Software as a Service (SaaS) model so all that is required to use one is a device with an internet connection and web browser. Bruker’s Arxspan suite, for example, is delivered as a 100% web-browser, commercial off the shelf (COTS) solution with all the functionality required for CRO collaboration. It is typically working out of the box, within 24 hours, via any of the standard web browsers: Internet Explorer, Google Chrome, Firefox, or Safari.
This level of accessibility is increasingly valuable. It means a new CRO can be onboarded and operational overnight giving you the flexibility to change plans rapidly to meet evolving needs. However, if this is the plan then bear in mind ease-of-use, training, and support. If you are going to expect partners to adopt your technology quickly then they may need someone to call on.
Equally importantly if your own work circumstances change you can be up and running from an alternative laptop or even a mobile phone seamlessly within the day. If your own lab isn’t operational you can liaise with a CRO to fill the gap and keep your research moving while working remotely.
Of course, for the pharmaceutical industry data security is of paramount concern. With modern systems it is easy to remove an organization as a collaboration comes to an end and fields or areas can be assigned as read-only, write-only or read-write depending on requirements, down to the level of individual scientists. These and many other features will provide the reassurance you need to grant the accessibility you require.
Learn more about the benefits of using an ELN here and ensure you have the robust and scalable infrastructure in place to take you through the coming years, whatever they bring.
Arxspan is a Division of Bruker.