The pharmaceutical and life sciences industry is a data-centric enterprise. Bringing a new drug to market requires a sharp focus on safety, efficacy, quality and data.
“Companies deal with massive amounts of data. Pharma and life science companies collect massive amounts of data which they need from a regulatory perspective. They need the data to support product development, to receive approvals from regulators, measure effectiveness, and track manufacturing quality,” said V. Bala Balasubramanian, senior vice president of the Pharma & Life Sciences Business Unit of Edison-based Orion Business Innovation Inc.
According to Balasubramanian, the challenge for pharma and life science companies is how to collect, curate and harness the data to help improve business processes, and use the data in more meaningful ways. Companies must make sure that the data is clean and usable, and that it makes sense when it is being reviewed and analyzed.
“At Orion, we work across the life cycle of pharma and life sciences. We work with pharma companies to transform their R&D, manufacturing and commercialization processes with the use of digital technologies. Once they get to market and consumers are given the medication, we support companies with the effective tracking of the safety profile of products,” Balasubramanian said.
Orion is a global technology services firm that provides digital transformation and product development services. They transform outdated and inefficient manual business processes like checklists and spreadsheets and automate them. Its main services are:
- Provides process and systems solutions for clients by streamlining existing regulatory information management processes, designing new processes and enabling them with end-to-end technology solutions.
- Provides process and systems solutions for clients by streamlining existing Quality Management processes, designing new processes and enabling them with end-to-end technology solutions.
- Helps with integration of data across the clinical value chain to get better visibility into effective planning of trials and analytics of clinical data from trials.
- Uses digital transformation techniques, such as artificial intelligence/machine learning, to generate greater insights, be it for drug discovery, identifying markets, or generating revenues.
“We’re seeing increased demand from pharma and life science companies to manage regulatory requirements, including the complex process of filing for a new drug approval. Our digital platform, called ReALM, helps companies successfully navigate through ever-changing regulations more effectively instead of managing them in spreadsheets,” said Balasubramanian.
Pharma companies, Balasubramanian said, need regulations to be managed more effectively so they can stay ahead and ensure compliance, otherwise they risk hurting their reputation and revenues.
“In addition, we support pharma companies [in managing] their regulatory and quality information to improve operational efficiencies across the whole organization. Another aspect we focus on is ensuring that data quality is high. We provide processes and capabilities to monitor data quality and keep it pristine, so data truly becomes a corporate asset.”
Based on predictions by industry analysts regarding new drugs in the pipeline in 2020, Balasubramanian is optimistic about the future business climate.
“We are in the business of supporting all these companies to make their processes more streamlined and more efficient, we believe that we have a big role to play.”