Almost all organisations, no matter the industry, are facing the need to manage and store information securely.
By Lenore Kerrigan, country sales director of OpenText
Life sciences companies are no exception – the drug development process is information and data intensive, and regulatory submissions, for example, can span hundreds of thousands of pages.
It can be daunting for team members trying to work together and navigate the complexities of storing, sharing and collaborating on documents across internal domains within life sciences.
This situation becomes even more challenging when you consider the ecosystem of external partners who also need to access information and participate in key business processes.
To help simplify this information overload, enterprise information management (EIM) solutions tailored to keep data compliant with industry best practice and government regulations are powering better ways of collaborating.
They enhance productivity by letting teams access and share information and manage tasks when working outside the organization from any location (such as an executive who is travelling or an external partner).
Most life sciences organisations have made significant investments in EIM systems and they are often customized to align with critical business processes. These systems hold mountains of critical information and include a web of software integrations within their operational systems that are necessary to support end-to-end processes.
Therefore, it is understandable that life sciences companies are looking for ways to deliver simplicity and improve productivity. However, they also want to leverage existing investments rather than embarking on large migration efforts or maintaining duplicate systems.
The good news is that today, the opportunity to deploy tools and solutions to help teams work better together both internally and with outside partners can accelerate workflows, cut down on problems related to document management and improve time-to-market, while keeping information secure and compliant as long as best practices are followed.
Simplify external partnerships
In order to improve development times and cut down on the costs of developing new products and services, companies in life sciences collaborate by sharing their skills and expertise. One example often seen today is the relationship between contract research organizations and pharmaceutical companies that sponsor them.
These strategic partnerships are underpinned by the ability to easily share information and collaborate openly, demonstrating the power of modern strategies for managing information.
For these partnerships to succeed, information needs to flow while staying secure. These external partners require access to sensitive or highly regulated documents that must adhere to the organization’s own security policies, and the larger regulations of the industry and region where the company operates.
There should be an easy way to enable this collaboration so as not to slow down any processes.
Break down internal and external barriers
Internal collaboration between departments in large organizations – especially life sciences organizations – is often difficult because in the past, compliance was the driver for keeping information locked down.
The result is that information is often siloed within departments. These silos of information have prevented users from easily sharing information (even with internal stakeholders). Today’s information management systems are letting users work more productively in that complex environment.
These systems are helping teams work better internally across domains, for example, sharing information between clinical, regulatory and quality assurance teams, and those capabilities are being extended to external partners and infrequent users outside organisations.
Sharing information internally means breaking down information silos and allowing critical content to be shared seamlessly with others without worrying about compliance. Sharing information outside an organization in life sciences presents additional challenges but current approaches to security enable information to be shared with key partners and stakeholders without adding complexity.
Make sure external partners are managed securely
Life sciences is highly competitive and organizations must be able to stay on top of applications, trials, regulatory work and other tasks (that all require multiple stakeholders – both internal and external – to review and approve), while adhering to the specific regulations around privacy and security for each country in which they operate.
With many partners to manage and engage, from contract research groups, to regulatory bodies and suppliers (supply chain management) users need a simple way to collaborate and share information.
When considering tasks and processes in the industry that must be done repetitively with the same high standards, such as quality assurance where there are many moving pieces, employees and partners must know and follow the same standard operating procedures.
Similarly, most people working in the regulatory and clinical areas need access to systems of record to review and approve content. Just as in any field, they are often under pressure to do their jobs quickly to complete mission-critical tasks in the chain.
Keep it simple for team members
While simplicity might be important for many industries, keeping information access simple in life sciences is not trivial.
The information and files being stored and shared are incredibly varied. From biomedical research to genomic data, documents and reports are often accessed by different teams for regulatory submissions, intellectual property management and research and development collaboration.
Beyond the diverse file types, the sheer volume of data makes it difficult to manage. These organizations are some of the most demanding when it comes to storing and managing data – often responsible for (1-billion gigabytes) of data and information.
With so many hurdles, users managing this information should not be forced to navigate clunky interfaces or be forced to undergo long training to understand how to use applications. Instead, today’s solutions are helping life sciences organizations collaborate and share complex tasks.
Life sciences organisations must strive toward giving users the ability to quickly organize and group related information in collections so users can quickly see different types of regulatory forms, documents or important data all from a single location.
Use information to keep improving
While gaining access to critical content and being able to complete tasks is necessary, organizations are also striving to gain new efficiencies by analysing the mountains of information they have accumulated on key business processes.
For example, modern big data tools combined with analytics can help draw attention to areas requiring additional support or oversight to help improve overall organizational productivity. Like a regulatory dashboard where the time from submission to approval is clearly indicated.
This type of graphical report can help a life sciences company focus its resources on areas where it lags and help it more accurately determine its regulatory strategy by market. Similar dashboards could be utilized to understand clinical trial sites’ adherence to submitting required paperwork.
Looking to the future
Enabling new ways of collaboration using cloud technologies is often a phased approach for life sciences companies, especially given the strategic nature of the information that must be managed, moved and the considerations required when evaluating the complexity of integrations with existing systems.
A tempered adoption strategy can be used, where certain cloud-based collaboration tools are launched while maintaining investments in existing systems.
A hybrid strategy allows life sciences organizations to use new technologies and tools to improve productivity, efficiency and remain competitive, while maintaining strict adherence to laws and regulations and leveraging and maximizing the existing investments.
As new techniques and technologies are developed, the sheer amount of data being produced by researchers and demanded by regulators will likely only increase.
Organisations will have to keep simplicity and the user experience top of mind as they continue to evolve the way they work with multiple stakeholders. As new technology is adopted, security, regulation and adherence to regional variations in rules must be considered when enabling new ways of collaborating.
However, the end-goal of creating new efficiencies in the industry through new technologies will help life sciences companies maintain their competitiveness as the industry continues to evolve.