Managing information is critically important to life sciences companies. Creating new products can take years of trial and error and every step in the process must be documented thoroughly—not only to speed internal development, but also to satisfy the needs of external partners and regulators. As a result, organizations in the life sciences industry can benefit from incorporating enterprise information management (EIM) solutions that have a proven record of quality and a history of meeting regulators’ needs. These solutions offer features such as workflow management, version control and audit trails, which are critically important for complying with regulations.
The need for information management platform solutions is increasing as new challenges face organizations within the life sciences industry. Competition is fierce, and companies are trying to balance the need to create innovative new products and research, while ensuring they carefully document every process and stay on top of regulatory compliance. It is a daunting task, but those who master it will have an edge over their competitors. Following are some of the key challenges life sciences companies must overcome if they hope to succeed.
Continued regulatory environment growth
Life sciences companies are required to comply with a complex and growing set of regulations. These include:
• GxP, which covers an array of compliance activities, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), designed to ensure medical products are safe and meet high quality standards throughout production. In Canada and the U.S. specifically, drug and health manufacturers must follow Good Manufacturing Practices (GMP),
• Compounding standards governed by the National Association of Pharmacy Regulatory Authorities, and
• ISO certification, which provides requirements and guidelines ensuring that processes and procedures in the manufacture of drugs are followed.
These regulations can vary from country to country, making compliance difficult to track for multi-national organizations. The regulations are also constantly evolving and organizations are mandated to keep up with these changes. For instance, one method of achieving this is through content management and digital solutions which are updated on a regular basis to ensure organizations have the proper regulations in place and are adhering to those regulations. Using a digital platform will assist these organizations to comply with any regulatory audits more efficiently.
Too often, important information and documentation are kept within one functional area of a life sciences company. For example, in research and development departments, much of the information generated is stored in a silo application not searchable across the enterprise, limiting its capabilities. Since this information is not readily available, it can’t easily be accessed by other departments or combined with other data sets to generate new insights that could lead to improved processes.
Due to the immense pressure of adhering to regulations, life sciences companies are understandably risk-averse and can be hesitant to change processes or procedures that have worked in the past. However, paper-based workflows isolate information that could be important to other divisions and make keeping up with regulatory changes more difficult. While many organizations have started down the path of digitization, there’s still a long way to go if they truly want to make the best use of the information they generate and improve their processes.
More off-patent products
More product patents are expiring, which means the industry is producing more generic products. Manufacturers of generics often rely on partnerships, with many teaming with patient advocacy groups, who are looking to boost access to more affordable medications for their members.
These partnerships result in a significant amount of new and complex paperwork, outlining the details of the arrangements between the drug manufacturers and the advocacy groups. Establishing trust between a life sciences organization and any patient advocacy group it works with is crucial. Patients may suspect that life sciences companies are trying to maximize their profits from their relationships with patient groups, so records must be kept of all interactions.
Transparency is also important to patient advocacy groups, meaning any partnerships with life sciences companies need to have detailed documentation that can be accessed quickly if there’s a request for information. Privacy is also a major consideration in these agreements. Organizations that use secure digital solutions to generate and store their generic agreements can save time and offer better privacy to their partners. Ultimately, partnerships between life sciences companies and patient advocacy groups can be beneficial to both sides.
Increased focus on patient rights
Patient rights are in the spotlight in many jurisdictions around the world and rules such as GDRP, HIPPAA and PIPEDA mean that clinical trials must be designed differently with granular security, privacy and policy management in mind. The increasing focus on the patient is resulting in more contracts, more regulatory reform and more minimum standards for clinical approvals. Tracking all of this puts an added strain on organizations within the life sciences industry. In order to handle all the documentation now required for clinical trials, they need modern digital solutions, enabling greater control over identifiable information and process management tools that follow legal requirements for consent management. This not only decreases the time it takes to generate contracts, but also makes it easier to track information and produce it for regulators or patients on-demand, boosting transparency and trust.
Continued debate over on-premise or in the cloud
Switching from paper-based submissions or exchanges with Clinical Research Organizations (CROs) or other third-party vendors to digital solutions isn’t the only technology consideration life sciences firms have to make. Once they decide to implement an EIM, they must decide whether to host it on their own premises, or whether they’d prefer to use a third-party cloud provider. In some cases, a hybrid of both cloud and on-premise will exist.
While many life sciences organizations have traditionally kept their information on-premises, the benefits of cloud-based solutions, especially when managing multi-stakeholder environments, are difficult to ignore. Today, building an on-premise solution can be costly–requiring significant up-front capital investment in hardware and software. It may also require more IT staff to install, maintain and monitor these systems on an ongoing basis.
Moving deployments to the cloud removes much of the maintenance responsibility as well as the up-front hardware and software costs. It can also give life sciences organizations more flexibility in their deployment options—for example, scaling the tools to additional departments and users as required. Service-level agreements outline how the data should be stored and secured in order to fulfil regulatory requirements.
With so much global attention on data privacy and security, having secure documents is a key requirement supported by cloud-based information management that provides secure access to these critical documents. In regulated industries, where multiple levels of stakeholders need to approve documents, appropriate cloud solutions provide secure sharing of information with internal approvals at the executive level as well as external partners and regulators. By setting up a secure cloud-based information management solution, regulatory managers working for life sciences companies can also get immediate updates on critical issues or follow-up on the status of documentation, even while travelling. With security concerns mitigated, working in the cloud can significantly reduce the time to complete regulatory approvals.
Unified digital data drives efficiency and insights
The rapid technological change in the life sciences industry is forcing the industry and, in particular, the regulatory teams to adapt and become more flexible, putting pressure on them to change their business models and personalize their products and services. For the industry, this means more data will be generated and stored. The pace of growth is only going to accelerate as medical devices with Internet of Medical Things (IoMT) capabilities come online. Whether it’s information from clinical trials, drug development or medical devices, companies need digital tools that not only can store, catalogue and analyze large data volumes, but also provide new insights.
To create value now and in the future, life sciences companies should consider participating in data-centric platforms of care that will help improve individual health outcomes and reduce costs. Incorporating solutions with artificial intelligence (AI) can help life sciences firms make sense of this massive level of information they generate and lead to new discoveries that can streamline clinical trials, accelerate the development of new medications and increase supply chain efficiency. But these benefits can be realized only if organizations overcome their internal information silos and pool their structured and unstructured data together without compromising data integration and security.
In this life sciences environment, digital platforms will provide the framework to create future value that is based on individualized outcomes and will be boosted by the industry’s ability to connect, combine and share their data. An Accenture report estimates that by 2026, big data analytics leveraging machine learning algorithms will be generating approximately $150 billion in the medicine and pharmaceutical industry. To cope with the more complex regulatory environment they face today and capture important data that can lead to more profit and efficiencies tomorrow, life sciences organizations will need to begin re-examining their workflows and processes, so they can begin to prepare for the digital future–the Fourth Industrial Revolution.
Ferdi Steinmann is Global Industry Strategist, Life Sciences, at OpenText. With over two decades of experience in the healthcare, life sciences and pharmaceutical industries, he has tremendous insight into the way technology helps companies become successful.