Ronen Vengosh (RV): Intellectual property is the ‘crown jewel’ of a biotech company and the true source of value, and collaboration with contract research organisations (CROs), investors, external parties and remote team members is the lifeblood. Decentralised clinical trials (DCTs), global partnerships and technology’s increasing role in improving the clinical trial process have revolutionised the industry. But it is vital that improving the ease of collaboration is not at the cost of protecting that data from things like ransomware and maintaining security and compliance.

The transition from paper-based to digital processes has largely neutralised many physical data security threats that were once common in clinical research. But with that solution comes new potential fail points in the process. Thanks to technology, it is easy to share data with collaborators around the globe, but are those collaboration solutions in place secure? Sending data sets via email attachment or messenger is convenient, but often at the expense of data security and compliance requirements.

RV: In the current era of post-pandemic remote workflows and DCTs, key stakeholders aren’t working out of the same office; they are distributed across the country or even the world. In DCTs, sponsors rely on vendors to help source and manage data outside of traditional sites. Without the right technology in place, providing those stakeholders with necessary access to a data management system to review data can become costly and cumbersome, even requiring people to travel to the physical location where the data is stored. The reality is that choosing to single-track the approach to solving collaboration and security hurdles will likely hurt the efforts overall. Instead, placing an equal emphasis on people, processes and technology when considering best practices and taking a more holistic approach to the solution sets a company up for long-term success. Putting stringent IT security measures in place alone hurts collaboration without solving the problem of how to collaborate. Companies need to create agile, interconnected workflows and then fold their technology into that workflow in order to protect their data and collaborate in this decentralised, post-pandemic world.

RV: Uploading and managing lab data in the cloud has revolutionised how companies approach clinical research over the last several years. That being said, transferring data from lab instruments to the cloud poses its own problems because many lab instruments are not built for cloud workflows. CROs face these issues all the time because they are ingesting large data sets from lab instruments then enabling external stakeholders to access, review, analyse, modify and approve the data. Without the right technology, this process is plagued with potential fail points that either jeopardise security or require tedious security measures, such as requiring people to travel to the location where the data is stored.

DCTs and digital solutions require serious consideration and balancing of security and compliance measures, collaboration, automation and protection against data sprawl. Balancing these factors is one of the reasons that a technology stack does not solve an organisation’s data collaboration and security needs. The approach needs to be more holistic and consider the impact of security measures on the efficiency and ultimately, costliness of a trial.

RV: There are many ways that the cloud enhances the workflows and efficiency of research in this industry. One of the broadest answers is to point out how the swathe of data collected and stored in a clinical trial can sometimes be overwhelming, but using a cloud solution with eTMF capabilities can help organise the data by study. By using an eTMF-specific solution and breaking that data out into specific studies, companies can have more control over their data in an audit-ready environment without compromising on collaboration capabilities. It’s also important for a company to ensure compliance throughout the clinical trials process, and by starting off in a GxP-compliant environment, the process won’t be slowed down by having to retrace steps for an audit or pause while waiting for a collaboration platform to get into compliance.

Cloud platforms also serve as a Statistical Computing Environment (SCE) for the analysis of clinical data by biostatisticians. In an SCE, organisations create an environment where raw clinical data can be imported and analysed with tools like SAS, R and Python. This code written by biostatisticians enables the efficient processing and analysis of data and the results are imported to reports that are used as part of regulatory submissions ensuring the integrity of your data, its access and the output of your analysis.

RV: Balancing a budget is always a challenge for early-stage life sciences firms and the real cost of IT is more than just the solution, they are hidden in implementation, maintenance and potential replacement down the road, so being penny-wise might be pound-foolish. Unfortunately, this often means companies utilise solutions that come with their existing technology packages rather than the solutions that offer the best balance of security and optimised user experience.

Many companies make the expeditious choice to use a system because it’s bundled in, only to realise a couple of years down the line that they are now locked into a very expensive rip-and-replace situation. Exchanging data without the proper security measures, especially in the post-pandemic world where collaboration across locations is at an all-time high, adds an extra layer of risk that could be mitigated with the proper solutions in place. We know that cyberattacks have gotten increasingly sophisticated and that companies who deal with sensitive data are a particularly attractive target for them, so it really is never too early to make that investment in IT.

RV: As I mentioned before, these early-stage companies often have a limited budget for IT and data security, but that isn’t reflective of the importance of a secure data collaboration platform for this industry. Oftentimes, these companies are left scrambling to get a compliant collaboration platform up and running in a relatively short period of time when they’re getting ready to begin clinical trials because it wasn’t a high-priority task before then. In order to support these efforts, some companies have created special offerings for this important part of the biotech industry to help these companies get off on the right foot, both in terms of being on a compliant platform and, more importantly, the collaboration and sharing of information seamlessly across locations and with third parties.

As I said before, intellectual property is where the true value of a biotech company lives. Holding that IP is valuable, but without the ability to share that value with off-site collaborators, both internal and external, its value is limited. Making it easy for these collaborations to happen, but also making sure that security is maintained, the data is protected, and knowing that when the time comes the systems can be validated, is key.

By providing a platform to these companies, data collaboration platforms are playing a critical role in ensuring companies can focus on getting their work done, rather than focusing on implementing systems. It's all about time-to-clinic and then the fastest time to regulatory approval.

RV: DCTs and the continued leveraging of modern IT solutions will revolutionise how clinical trials are run across the world. The ability to use multiple labs to run trials, hire the best talent regardless of location and increase the efficiency of data management without losing any ease of collaboration, and often enhancing it, mean faster time-to-patient and more cost-effective trials while maintaining compliance. The goal is a future in which companies can share data with their partners (eg, CROs) without having to think about how to do it, how to secure it or how to make sure that the data is compliant. This will include systems that do the sharing and transfer the information automatically, without losing data integrity and while ensuring compliance. Utilising these systems for connecting lab instruments to scientists to cloud services, and therefore facilitating seamless transfer of information from CROs to sponsors, is the next step in improving clinical trials.