Life Sciences & Healthcare
HCL has been supporting 2000+ applications across the Pharmaceutical Value Chain i.e. R&D, Manufacturing & Supply Chain, Sales & Marketing for top Pharmaceutical companies in the world. HCL has extensively analyzed the incident & service request volumes and mapped them to the corresponding Pharmaceutical business functions & sub functions. This has enabled us to identify top focus areas & pain points in the ASM services.
Basis this rich hands-on experience, HCL has built an exhaustive array of domain specific tools, dashboards, mobility solutions, plugins and solution accelerators for proactive reduction & obsolescence of ticket volumes to transcend the journey to the end state vision of ALT ASM™ of reducing the application support ticket volumes to zero.
- HCL’s ALT ASM™ user friendly CRF Book Generation tool (CBG)
Our domain driven analysis & insights reveal that one of the key business sub function which has contributed maximum ASM incident & service tickets is Clinical Data Management – Case Report Form (CRF) Book Generation. For a typical Phase III/IV trial, a CRF contains 15 pages per visit per patient. Each page may contain as many as 50–60 individual data points, and a total of 15 visits are not uncommon.
Given that a typical Phase III study involves around 500 patients, over 6 million pieces of data are obtained for an average trial. Multiple requests are received by IT support team from Research coordinators/Study owners for case book generation and extraction. To serve these requests, multiple iterations happen in getting requirements clarified from Business.
HCL’s ALT ASM™ user friendly CRF Book Generation tool (CBG) provides on-demand extraction and generation of case report form without an intervention from IT support team and reduces lead time by 30 to 60% per patient per visit.
- HCL’s ALT ASM™ ACK’s monitoring tool
One of the key business sub function which has contributed maximum ASM incident tickets is in the Pharmacovigilance business function related to E2B Acknowledgements Monitoring for better management of Regulatory Reporting.
On an Average 100-500 E2B reports generated per year per product. When an E2B report is submitted to Health Authority or License Partner, an acknowledgement (ACKs) will be sent back to the submitter and is loaded into the safety system. These ACKs may be received but not loaded in the safety systems due to special characters. Some ACKs are not received and some may not be sent by Agency in a timely manner.
HCL’s ALT ASM™ ACK’s monitoring tool provides assurance of an accurate status of Acknowledgments received from Health Authorities for every E2B report submitted with our E2B Acknowledgements monitoring tool which eliminates manual efforts to monitor and fix the error.
- HCL’s ALT ASM™ Availability Management Dashboard
One of the key contributors to the critical ASM incident tickets is due to the availability issues of the critical Clinical and safety suite of applications. High degree of monitoring and availability management is required for these critical portfolios of applications.
Often monitoring tool in the markets are not business friendly and not customizable for validated environments. Given the criticality of these systems, it is imperative to be able to monitor them through mobile devices.
HCL’s ALT ASM™ dashboard on mobile provides unlimited capabilities to monitor and manage clinical and safety applications over a smart phone using a single dashboard to ensure business continuity and reduction in critical incidents.
- HCL’s ALT ASM™ plugin production scheduler
One of the key contributors to the critical ASM incident tickets is due to the orders not visible in the Production Execution System. Orders from upstream applications do not get visible to Production / Manufacturing Execution System due to interface failures.
An estimated 20 to 30% of incidents are in Production Executions in major Pharmaceuticals. Inability to generate the batch before releasing Orders to Production due to service failure results in idle time for the system, as the orders are not quickly released for production.
HCL’s ALT ASM™ plugin production scheduler will provide visibility to orders from upstream to downstream and ensure zero delays in order processing and completion with the MES, reduced order cycle and system idle time and increased productivity.
- HCL’s ALT ASM™ Content Management Solution
One of the key business sub function which has contributed maximum service tickets is Sales & Marketing Content Management. A new product launch requires existing product websites to undergo frequent content changes which include product promotions and campaigns.
Multiple product websites are being maintained due to geographic spread and multi-lingual requirements leading to high number of service requests during product launch. HCL provides a standardized, single technology platform for effective & efficient Sales & Marketing Content Management.
HCL’s ALT ASM™ Content Management Solution accelerator will help get publishing ability through a standardized, single-technology platform and gain 20 to 25% savings on infrastructure and licensing costs, 30% volume and effort reduction due to consolidation and 20% reduction in cycle time for creation, setup and deployment of sites in different Geos.
GxP Compliant ALT ASM™: HCL ALT ASM™ engagements leverage HCL’s Regulatory Compliance & Validation CoE to ensure the involvement of subject matter experts and robust internal & external audit capabilities by RAPS certified auditors. Our proactive risk mitigation strategies reduce the risk of non-compliance with proper risk assessment methodologies. Predefined protocols covering all the qualification requirements based on the industry best practices are employed to ensure compliance with GxP, Gamp 5, 21 CFR Part 11 and any local agency requirements.