As life sciences companies look to bring innovative new drugs to market, they are seeking progressive ways to resolve long-standing issues that hinder regulatory compliance, productivity and total cost of ownership (TCO).
Being able to bring together seemingly disparate tasks – clinical data management, medical information management, global regulatory affairs functions, pharmacovigilance and safety and beyond to commercialization and marketing – onto a single platform, where data can be shared and analyzed with ease will dramatically improve processes.
Given the clear benefits, what have been the barriers to better integration?
Over the past few years, progressive life sciences companies have moved steadily toward a more holistic state with managing their data, for example through progressive regulatory information management systems, medical information management software, adverse event management systems, clinical trial management systems (CTMS), and risk management software solutions, among others.
But until more recently, technology and infrastructure – while certainly providing huge benefits to companies in terms of managing their data – weren’t able to go beyond and connect organizational data across multiple functions. A real transformation – one that connects every primary function of the product lifecycle – was paramount.
How has that transformation been made possible?
At the top of the list, the increasing move toward open architecture and seamless integrations is removing the barriers and enabling end-to-end management of the product lifecycle. A single platform can only be made possible by moving beyond limited and rigid infrastructure and processes.
Open architecture, one that can be integrated with solutions from multiple vendors, will improve cross-functional process efficiencies, collaboration, control and visibility of information to deliver a single source of truth.
Among the other critical elements to transformation are:
- Cognitive computing and digital technologies that take advantage of advanced machine learning capabilities, natural language processing (NLP) – or artificial intelligence – to automate operational processes, reducing processing time and allowing experts to focus on strategic activities
- Multi-tenant cloud-based solution, to achieve greater efficiency, improve data quality, enhance security and compliance, and deliver a lower, demonstrable total cost of ownership (TCO)
- Industry standard best practices across core processes – be that to new regulatory requirements including IDMP compliance, or established practices including investigator safety reporting , medical communications, adverse event reporting (SUSAR) or signal detection, to ensure that time is spent focused on product innovation rather than on reinventing the wheel
ArisGlobal believes that life sciences companies should not have to compromise on innovation and managing the product lifecycle. Our complete LifeSphere® platform removes the complication, cost and time-consuming issues typically associated with platform integration to deliver a TCO approach across the business.
Join at the annual DIA 2017 Annual Meeting in Chicago from June 18 to 22 to learn more about our integrated LifeSphere platform.