With today’s need for speed and efficiency in the life sciences industry, Regulatory Affairs, Pharmacovigilance, Clinical Research, and Quality Management cannot operate as independent islands within a pharmaceutical organisation. These departments must function as a cohesive ecosystem, sharing data, insights, and workflows seamlessly. The interconnected nature of drug discovery, from clinical trials and regulatory compliance through to safety monitoring and quality management, demands a holistic approach to information management and process design.
Yet many organisations still lack the systems and resources required to break down barriers between these critical functions, thus losing out on increased operational efficiency, a faster time-to-market, and streamlined compliance.
Read on to discover how the CARA Life Sciences Platform brings together all functions of life sciences throughout the end-to-end journey of a medicinal product, from discovery all the way through to post-marketing.
Meet Barry. Barry is a drug created in the CARA Life Sciences Platform. To see the connections made between functions and processes during the product development lifecycle, we’ll follow his end-to-end journey through the platform.
Non-Clinical Trial
Barry begins his life in the CARA Life Sciences Platform as an active substance and, in order to test his suitability, a non-clinical trial is created to test Barry against various species. The data collected is put into the system and connections begin to appear between the active substances, non-clinical trial data, and of course all of the documents that are created as a result. For these, we have CARA’s core Document Management functionality: authoring, review, approval, and collaboration.
At this stage, we begin to see the first set of connections form; between master data and core data used in the process so far, which now begins to connect with all of the study documents and data used in the non-clinical processes.
The non-clinical study is successful, and so Barry is created as a pharmaceutical product within the CARA Life Sciences Platform. As a result, a clinical study is planned.
But, in order to proceed with the clinical trial – authorisation from the authorities is required. Traditionally, in order to apply for permission, the process would be handed over to the Regulatory team, where applications are managed in a separate system that doesn’t contain any of the data from the existing studies.
Clinical Trial Authorisation
With the CARA Life Sciences Platform however, everything needed to compile the submission is already in the platform. Using the platform’s many regulatory use cases, regulatory users can put together the submission, submit to authorities, and receive a decision. Any correspondence from the authorities is managed, tracked, and stored in CARA.
The connections are beginning to really build in the CARA Life Sciences Platform. We now have all of the clinical and the study data, regulatory applications, and submission content all sitting within one, true platform.
Now that we have received authorisation to continue with our clinical trial, we head back in to the Clinical workspace on the platform where we can update our study data records. Included here is the management of study data, tasks and issues that will arise as we progress with the study, site visits, communication records, and everything that we want to log against the study, its countries and sites.
Also included here are all of the study documents, utilising the core Document Management functionality at the heart of the CARA Platform. In order to structure that mass of documents such as trial plans, milestones, completeness checks and reports, CARA offers a host of features for eTMF which now also link back to that web of connectivity within CARA.
Also connecting at this stage are the Safety and Quality domains, with safety cases arising as part of Barry’s clinical trial, and some aggregate reports made as a result of these cases. It is possible that some complaints may have been received during the clinical trial stage too, and so these other areas of the platform begin to bleed in and link up each area of the organisation.
Regulatory Submission
Now with sufficient evidence, it would be appropriate to apply Barry to market, using CARA’s many regulatory use cases to compile the submission.
This submission is pulled together from all the different places that we’ve been collecting data and authoring documents throughout the lifecycle so far, and we’re going to need a number of experts from different functional domains or partner companies to help put that together. Eventually, the application is made, approved, and Barry is allowed to be sold on the market.
Safety Cases and Quality Events
For Barry, the work doesn’t stop there. Now Barry is available on the market and the public have been using the drug, it’s possible some complaints have been made and are logged within Quality in the CARA Life Sciences Platform. These complaints may be linked via metadata to safety cases that have arisen. Through this, we have to create, author, and submit aggregate reports.
The complaints and safety cases that have arisen may require us to create a quality event in CARA to update the information on Barry according to our internal workflows, and from this we may need to spawn some variations. These variations can be any number of things; changes to labelling, an updated shelf life, or a change to any information that relates to Barry as a medicinal product. Using the quality events as triggers, we manage these variations, submit them, and track them all within CARA.
For this process we have the same use of tools as with Marketing Authorisation; applications, activities, events if it’s a global variation, and of course submission authoring and review for the documents and structures we plan to submit. With all of this, we can publish and submit to the authorities, and track the outcomes and validity back into our varied registration.
This process will continue and cycle as changes are made to Barry across his lifecycle. The important thing here is that now, those variations are linked within the CARA Life Sciences Platform, completing the connections between all functional domains of a pharmaceutical organisation, all within a single platform.
The data created during a product’s lifecycle comes from many different sources and requires contributions from many people. The aim of the CARA Life Sciences Platform is to take all of the parts of that process that can be simplified, and simplify them. With our platform, you can save time with automations, avoid duplicate work, and maintain consistency and compliance.
The CARA Life Sciences Platform thrives at connecting all areas of Life Sciences on a single platform, powered by a single information lake. We can show you how to streamline your operations by bringing together RIM, Quality, Safety, and Clinical processes, or, if you’re interested in a system for just a single area, we provide off-the-shelf business processes crafted based on decades of combined industry expertise and the most up-to-date regulatory guidance.
Interested in learning more? Book a demo today.
