Client Background

• One of the top 5 global pharmaceutical companies
• Present in APAC, EU and US regions 

Challenge

The client had acquired a billion-dollar company to expand their businesses in US and Europe. However, their existing bandwidth did not allow the company to utilize their production capacity to the fullest, thereby leading to delay in submission and high operational costs through consultants. The client realized the need for full time resources from a strong Medical Writing service provider. The aim was to align the processes, structure and introduction of digital transformation by setting up a global business hub.

Solution

91¿ì»îÁÖ provided safety writing services related to authoring and reviewing of regulatory documents such as CSRs, IBs, Protocols, PSURs, PBRERs, PADERs, RMPs that are required for Regulatory submission in Europe, APAC and USA regions. To this end, 91¿ì»îÁÖ setup global hub adhering to client’s mandate on process Quality checklists while maintaining governance with key stakeholders for strategic decisions, data validation, assessment and evaluation of reports to meet regulatory compliance. We ensured:

• The quality of reports delivered are always ≥98% of client-determined SLAs (quality and time)
• 91¿ì»îÁÖ invested in digital transformation tools that were used to perform literature search. All articles were delivered with rationale on inclusion and exclusion criteria
• All reports met the regulatory requirements through transformation and in-house tools implementation. These tools – that are cloud based and secure to use – resulted in better operational excellence, accuracy as well as cost savings. It also helped management of scalability and volume spikes, and resulted in significant reduction in manual efforts
• Replacing of all non-HCP verifiers with HCPs to strengthen quality delivery. Cross skilling of resources to manage high volumes and ad hoc support
• Lean & Six Sigma Frameworks to reduce internal reverts and improve quality scores, digital audio recording scores and data capture 
• Internal alignment and streamlined processes with transformation to increase client’s business revenue for this program by 10% in first year

Business Impact

Cost Containment - Around 35% reduction in overall operational cost achieved through economies of scale

Compliance - 100% compliance adherence 

Transformation - Increase the quality output and efficiency with introduction of in-house tools and process automation

Scalability - Proven capabilities to scale-up operations for expanding in any region

Operational Efficiency - Significant improvement in volume, quality and turnaround time due to process standardization

Delivered value added services