Pharmacovigilance is a patient safety program run by all pharmaceuticals and medical devices organizations. For obvious reasons, it is strongly governed by regulatory authorities across the world. Patient safety programs differ across organizations. In many cases, multiple internal departments within an organization run it differently. Hence, it is a challenge to adopt a harmonized, homogenized, and standardized process across the operations life cycle. Listed below are a few common challenges that every organization is trying to overcome.

Industry expectations from Pharmacovigilance automation solutions include the ability to end-to-end pharmacovigilance operations. In addition, the automation solution should:

1. Capture data coming from various sources like calls, emails, fax, literature, scanned copies, images etc.
2. Extract data into a structured format
3. Analyze data for validity of adverse events, duplicity, severity, completeness, and correctness, and finally upload it on to a patient safety tool to generate regulatory reports
4. Address many manual handovers and provide a standardized process

Figure1: Pharma co-vigilance challenges, priorities & tech transformations

Figure 2 depicts traditional pharmacovigilance activities and expectations from automation-driven operations.

Wipro has developed a unique PV Automation Service Platform called TaloSafe for achieving a complete, correct, and compliant output through a global delivery model so that pharmacovigilance operations teams can ensure clinical and compliance corrections of cases.

TaloSafe includes intelligent automation driven by RPA, artificial intelligence, proprietary workflow engine, and operations management systems that enable you to customize processes and metrics to the client’s specifications. The framework lets you track the process, monitor metrics, and extract meaningful reports. The below image depicts activities that TaloSafe can assist you with

Figure2: Pharma co-vigilance Challenges, Priorities & Tech transformations

Wipro leverages innovations and tools to facilitate auto receipt of cases, along with auto-validation and duplicity checking. The tool also routes invalid cases to the appropriate associate, prompting him/her to either remove them from the workflow or get further inputs for completing the cases. The solution also supports auto-uploading of cases on to the safety tool thus reducing operational efforts. We believe the key drivers for this initiative are to:

• Achieve flexibility in the pharmacovigilance solution to become a more flexible and easy-to-scale, outsourced, SLA-driven, service-oriented model
• Enable the quality and efficiency of PV operations to deliver in a secure, proficient manner
• Achieve a risk-free, seamless implementation of the new safety solution
• Alleviate the bandwidth of our customer’s existing staff on standard PV operations and implementation management

Figure3: ICSR automation with Talosafe

With operations spanning the globe, having processed almost 1 million PV cases supported by a dedicated CoE (Centre of Excellence) setup for patient safety, Wipro is well placed to deliver Man + Machine solutions for our customers.

TaloSafe will help to identify, validate, and redefine/re-enter important information from cases to safety platforms (Argus, ARISg). The aim is to build a process platform where safety cases are cleaned, duplication is identified, and information already uploaded on safety tools is vetted, and to perform corrections wherever required to be able to submit back. It also has additional features like:

• AI & ML based automated case intake and processing
• Multiple case intake channels with cognitive BOTS identification of exceptional instances and follow-ups
• Automated safety database entry
• Operational & performance insights
• Integrate with existing tools toward seamless in non-intrusive ways
• Self-service capabilities with better user experience and faster resolution

Key Differentiators   

• Unique factory-based operational model for striking balance between efficiency, compliance, quality, and effectiveness
• Automation-driven operations culture Experienced resources and ready infrastructure
• Diverse BPO Experience in ICSR processing received from various sources viz. spontaneous, clinical trial, literature, solicited, social media etc. for drugs, OTCs & medical devices
• Robust operations experience in safety database (Argus, ARISg)
• Business excellence team (LEAN, Six Sigma) for continuous PV process improvement
• Healthy partnership with a long-term, value-driven approach to pharmacovigilance