The Pharmaceutical and Life Sciences industry is battling increased regulations, reduced R&D productivity, cost pressures, IP infringements in developing countries and industry consolidation. Organizations are facing the dual challenge of finding new molecules while addressing the operational demands of the day. PureSoftware has been helping clients in the areas of Drug Development, Product Safety, Regulatory and Sales and Marketing by developing and implementing new products and applications. We are involved in providing services in areas like Clinical Data Management, EDC product development, AERS, CRM, Salesforce Management, implementing document management systems for submissions etc. We have expertise in regulatory compliance areas like 21 CFR-11, HIPAA, CSV, GxP etc. necessary for working in this industry. Our partnership with Oracle has helped us build expertise in products like Inform, OC, Argus, IRT etc.
Argus Safety Upgrade and Implementation for a Japanese Pharma
A Japanese pharma required an Argus safety upgrade and implementation. The major business challenge was to upgrade the old version of Argus security to version 7.0.2, implement Argus safety in Japanese, move all the system in Japanese to Argus safety and create a global workflow. In order to carry out the whole process with utmost efficiency, we created a new setup of Argus 7.0.3 with clean configuration and migrated only the good data from the earlier version 5.0.2. The end result was a consolidation of Japanese and English case processing along with reduced cost per case spent by the company.
Clinical Trials Automated Testing Of DW – BI Application
PureSoftware was required to automate the impact analysis and regression testing of a DW-BI application. The major task was to reduce the time of regression testing. We created a keyword and data driven framework using QTP. Instead of using GUI for data validation, the team decided to use XML and HTML. After the automation, the execution time reduced to 1/6th of the previous number.
Pharmacovigilance and Safety Application Testing
A Pharmacovigilance product needed to be validated and safety application testing was also to be conducted, for a pharma-based client. The product had a huge licensed customer base all over the globe. It needed to be compiled with global safety standards. PureSoftware used business process automation testing framework for high domain testing at low cost. Risk prioritized test execution assured better risk coverage for the product. Finally, the team received a high functional test coverage. Also, risk prioritization significantly helped in the identification of critical bugs.
Automated Federal Submissions
The team at PureSoftware was required to deal with automated federal submissions. A way to increase the operational efficiency of submissions management personnel, at a global pharmaceutical major, needed to be found. In order to tackle the aforementioned challenge, the team developed an intranet site that could be accessed by submission groups worldwide. By the automation process, the efficiency, as well as accuracy of the submission group, was increased.
IoT Based Multi-Level Car Parking Management
One of our clients had issues in multilevel car parking as users couldn’t locate the car, empty parking. Checking levels and notifying customer required resources. We at PureSoftware, developed an IoT based multilevel car parking solution, providing in-out movement of vehicles at each level, notifying users, informing empty space, automated fee, enhancing customer experience, management, and an automated bill.
IoT Based Waste Management
Our client, who was into garbage management, faced problems of disorder, untimely removal, and unaware manpower on the quantum of garbage. We at PureSoftware developed a system monitoring garbage levels in bins real time, notify drivers, with the shortest route, unattended bins, and analyzed data location wise. Reducing fuel consumption cost, optimal usage of resources, time, and be responsible institute.
Development & Testing For Complex Clinical Trials
Our client needed two Sprint First 6.1 trails, to be delivered within strict deadlines, each challenged with frequent form changes. Our Team, using Split-Go Approach delivered both within deadlines. High-quality trails in UAT, TRN delivered with zero production issues passed in QAR1 saving time and cost.
Development & Testing For Complex Clinical Trials
Our client faced the challenge of complex customer requirements, including repeated forms, visits, clarifications, additions and deletions causing huge turnaround time and technical issues for CD Admin team. Our Team deployed BA and highly skilled programmers competent in understanding and handling requirements, resulting in 2FS and 4FF trials, below 2% defect rates within deadlines.
Clinical Testing Capabilities
Our client needed to develop and implement end to end trail life cycle using Inform and CD having unstable requirements and form changes. Our Team, using the Split-Build approach made frequent updates possible in each sprint, thus completing form design, UI Screens, delivery before FPV, trails delivered with <2% defect rate and high-quality complex rules delivered and QA1 pass.
L2 Application Support for Healthcare Products
Our client required L2 application support on seven different Oracle products for clinical studies. Our cross product experienced team was able to quickly transition knowledge and establish an ITIL compliant L2 support for the client. Throughout the engagement we were able to achieve improved CSAT scores, reduce the Average Resolution Time, meet and improve SLAs month on month basis and reduce incident backlogs by 50%.