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The recognition highlights our continued growth, innovation, and commitment to excellence in Pharmacovigilance Industry.

Being part of the Forbes India Select 200 – DGEMS 2024, is a testament to the hard work and dedication of our incredible team. It reflects our relentless pursuit of core values like customer satisfaction, cutting-edge technology, affordability, agility, sustainability, etc. and our vision that until such time we empower humanity with the fundamental right of “Affordable Health for All”, we shall strive for constant path breaking innovation.

This recognition by Forbes underscores our ability to adapt to changing market dynamics and lead with innovative solutions. As we continue to grow and evolve, we remain committed to driving positive change, fostering strong relationships with our partners and clients, and creating long-term value for our stakeholders.

We extend our deepest gratitude to our employees, customers, investors, and all who have been part of this journey. This achievement would not have been possible without your ongoing support.

Mohit Gupta, Vitrana CEO said “We are honoured to be recognised by Forbes India alongside such a distinguished list of companies. Today, we are servicing organizations spread over five continents, but our penetration can further be enhanced and increased to make sure that we touch life of 7 billion people globally. As part of our strategy, we have been investing heavily in research and design in expanding our offering list and making it more compatible with the upcoming Generative AI capabilities and making sure that we become more affordable and accessible to the masses. Forbes India, DGEMS is a wonderful platform. It brings the smartest of the minds and successful brains together. I have even identified as I speak today multiple organizations who are part of DGEMS global list of 200 and are doing business like what we are doing in our domain. Partnering with them will make sure that we have new service offerings co-developed with these organizations and create a much stronger reach.”

Click to watch the exclusive interview.  

Stay tuned for more updates as we strive to maintain our leadership and build an even stronger future together.

About Vitrana

Vitrana offers Life sciences and healthcare software platform supporting both SaaS and on-premises deployment with process automation, data driven business optimization, open-integration, data standardization, enterprise search, analytics, and predictive outcomes, reducing total cost of operations and enhancing regulatory compliance and patient safety. Vitrana also provides software consulting and turnkey solutions through automation of work processes, Automation through ML, NLP & Deep Learning, data migration, integration, hosting and cloud adoption, application management support, validation, business configuration and point solutions within the fields of drug safety, regulatory compliance, and outcomes research.

About Forbes India Select 200 – DGEMS 2024

The Forbes India Select 200 – DGEMS (Dynamic Growth Entrepreneurs and Market Shapers) is an exclusive recognition program that celebrates companies demonstrating exceptional growth potential and industry leadership on a global scale. Curated by Forbes India in collaboration with DGlobalist, the DGEMS list highlights businesses that are transforming industries through innovation, scalability, and impact. It serves as a platform to spotlight high-performing enterprises breaking geographical barriers and shaping the future of their sectors.

Vitrana adds another Milestone to its ongoing successful implementation of TransformPV with one of the largest pharmaceutical organisation “Live” with TransformPV for meeting FDA eMDR requirement. The organization has implemented Vitrana’s TransformPV solution to meet its R3 eMDR regulatory requirements. TransformPV has enabled them to:

• Avoid the double data entry in source system (Argus) and eSubmitter
• Submit and track eMDR report through source system (Argus)
• Have single source of truth for data entry and submission tracking
• Easy to understand R2-HL7 side by side, which takes away the difficulty of understanding HL7 structure for the business users

Vitrana’s TransformPV, the preferred solution for meeting R3 requirements recently went live at biggest Pharma organization in the world. Despite the significant complexities the implementation went very smoothly and implementation was achieved within a timeframe of 10 months. In current scenario with a defined FDA Guidelines and no major updates expected, the TransformPV implementation can be managed through an accelerated approach and can be accomplished between 3-5 months based on the chosen validation methodology.

TransformPV is the only solution in the market to have successfully gone live with both Vaccine R3 and Device HL7 reporting.

Since the go-live there have been hundreds of successful submission to FDA VAERS and eMDR.

During the course of the project there were significant updates introduced in the guidance, but due to design of TransformPV platform there was minimal impact of these updates and we were to able turnaround with updated solution within weeks instead of months.

As we look back at this significant milestone, there are few critical success factors we would like to share for organizations who are planning or in process of implementing an R3 capable solution:

Detailed requirements Assessment

• To Identify impact to company’s system and processes
• How to manage new data in R3 e.g. Amendment, EU Causality Assessment, Vaccine fields, nullflavors
• Manage organization specific customization
• Prepare the business for upcoming regulatory changes and R3 framework
• Additional data needs and business process updates required
• Identify upstream/downstream implications

Close coordination with regulatory agency

• Multiple discussions with FDA resulted in significant updates in VAERS regional guidance in July/Aug 2016 (the updates prevented one of top 5 pharma organization to roll back their R3 solution)

Here’s some interesting details from the last implementation:

• First solution to successfully go-live on Vaccine R3 and eMDR HL7 format
• Project completed in 10 months despite multiple updates to regional guidance
• Before the formal pilot with FDA, approx 200 R3 and HL7 were submitted to FDA as part of informal pilot
• Feedback from project team to FDA resulted in major updates to VAERS guidance
• Agency acknowledged the positive impact by the project on the final guidance

TransformPV platform allows organization to manage their R3 compliance needs without significant investments and allows them to focus on more pressing needs. The platform is scalable to meet future requirements and comes with features like R3 only viewer, R2-R3 view for transmissions, Integration with LDAP and Documentum.