Automating Clinical Operations @Scale

In the U.S. alone, the pharmaceutical sector of the Life Sciences industry spends over $80 billion on R&D each year¹. It can take 12-15 years for an experimental drug to go from lab to patients². A phase III clinical trial can last from 1-4 years and require up to 3,000 patient volunteers, with only 25-30% moving forward to the approval (NDA submission) phase with the FDA³. All told, it costs on average $2.6 billion to discover and develop a new drug. In addition, SG&A expenses can consume as much as 40% to over 50% of revenue due to the complex nature of bringing new, innovative therapies to market in a highly regulated industry. Shrinking margins from pricing and inflationary pressures, the ever-present generic competition, disruption from New-market entrants and emerging technologies are also diverting Life Sciences resources from the bigger mission. Not surprisingly, most companies have implemented Business Process Management (BPM) solutions to streamline complex drug approval processes, cut clinical trial costs, and lower overall expenses. Digital Process Automation (DPA) is the next step in your digital transformation journey.

Given today's highly evolved eCommerce landscape across industries such as Banking and Financial Services, Insurance, and Consumer Goods, Life Sciences customers, patients, and caregivers are demanding and expecting better access to information, more services, and a digital experience comparable to the aforementioned industries. In addition to offering BPM benefits like cost reduction, process management and compliance, DPA also supports customer-focused applications that enhance user experience to improve business and health outcomes. Moreover, DPA platforms provide advanced digital tools like Low-code/No-code (LCNC) to create, automate, and optimize business operations faster, cheaper, and better than their BPM predecessors. 

Coforge partners with leading DPA/LCNC platforms such as PEGA, Appian, Outsystems, ServiceNow, and Salesforce/MuleSoft, leveraging deep domain expertise across the Life Sciences value chain to deliver solutions for mission critical systems like Clinical Trial Management, and Pharmacovigilance (Adverse Event Reporting, Drug Safety, and Product Quality).

1. https://www.cbo.gov/publication/57025
2. https://www.fdareview.org/issues/the-drug-development-and-approval-process/
3. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#Clinical_Research_Phase_Studies n
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