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:
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:
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: