• The Site Team had to capture the complete adverse event information in a pandemic situation through a video conference.
• Additionally, the Site Team also had to facilitate the subject’s timely visit to the site for event analysis by following COVID-19 protocols mandated by the government.
• Ensuring subject’s safety against COVID-19 infection during the site visit was a critical priority during the peak pandemic time.
• With Techsol’s Clinical Operations team working from home, it was challenging to perform meticulous evaluation of the reported event and classifying it accurately as a Serious Adverse Event (SAE) as per clinical study protocol.

• The Site Team was trained on the ‘COVID-19 Risk Management Study Guidelines’ that had to be followed for facilitating subject site visits and handling of AEs and SAEs. 
• Techsol’s Pharmacovigilance and Clinical Affairs team ensured that the Site Team handled the subject visit with all pre-cautionary preventative measures to avoid a COVID-19 infection during the entire visit.
• Techsol’s team coordinated with the Site team to investigate and accurately capture the SAE’s.
• The Principal Investigator examined both eyes and diagnosed Cystoid Macular Edema which was severe in the Subject’s right eye. 
• Techsol’s Medical Expert reviewed and advised the PI to prescribe the appropriate concomitant medication to resolve the SAE.
• The SAE follow-up visit was scheduled and completed after 14 days from the date of the subject’s site visit.
• After completing all the follow-up visits, the Investigator prepared the final SAE Report and submitted to Ethics Committee and DCGI Regulatory authority.

With the COVID-19 experience, CROs, Site Investigators and Sponsors must ensure that the following best practices are implemented as standard processes for SAE handling and reporting:

• Establish effective site communication channels (telephone, video conference, etc.) to provide timely support to the Subject during an adverse event experience. Based on this case study, it is certain that using the right technology can minimize patient burden and faster resolution.
• Ensure that the clinical study site and CRO has the right infrastructure and relevant standard processes that must be followed for arranging subject visits during an unprecedented situation.
• Clinical teams must have ready-to-implement tested safety protocols for facilitating safe and convenient site visits to subjects in the event of a disaster.
• Medical review plays a significant role in determining causal relationships to avoid misclassification of adverse events and timely reporting of SAEs to health authorities.

Hugel had products that were ready for market and needed a drug safety solution in place. The knowledge of the team with respect to the process for implementing a safety systems was inadequate. They were banking on a partner that could deliver a fully validated system accompanied by project management. The key challenges faced by Hugel were:

• A limited understanding of safety system implementation

• Having a fully validated safety system ready in time to market the drugs

• End-user training for the system was required

Techsol and Hugel worked together to deliver a system that met the business requirements through seamless project management.

• Implementation of Argus Safety v7.0.4.1 on Oracle Cloud was expedited following Oracle’s delivery of the Argus licenses.
• The entire system was validated by Techsol to ensure compliance with regulatory rules and guidelines.
• End-user training was provided to ensure the Hugel team was able to work with the new system effectively.
• Post-implementation ‘hypercare’ (24X7 support) by Techsol made sure that issues were resolved with minimum downtime.

Hugel gained many benefits through the efficient implementation of the drug safety system:

• A timely delivery of the drug safety system
• Fully validated system as per GAMP 5 guidelines
• A 50% reduction in human effort for case processing
• A system for end-to-end case processing meeting regulatory compliance requirements
• Compliance audit readiness through the control and recording of all pharmacovigilance and case processing activities

Ipca had performed a rigorous assessment of their current drug safety process, regulatory requirements, system requirements (both current and future scale up) and observed that there were opportunities for improvements across processes, systems and their vendor engagements.
Following were some of the key challenges for Ipca:

• The two safety databases were not integrated, resulting in omissions, redundancies and leading to compliance challenges
• There were unmet needs such as advanced signal detection/ management and automation of case submission with agencies via gateway
• Inefficient management of global operations as each region was following a different workflow for case management. Case processing was challenging resulting in missed timelines and increased costs.
• Reporting, insights and signaling was challenging due to lack of right tools and due to separate databases

To fulfill Ipca’s business objectives of optimizing their drug safety operations, Techsol proposed a comprehensive solution with the accomplishment of the following activities:

• Implement AccelSafety with the Oracle Argus Safety Standard Edition along with Empirica Signal/Topics and Oracle B2B Gateway for Ipca on Techsol’ fully-managed cloud platform
• Assess and implement configuration best practices including harmonization of P&L (Products & Licenses), submission workflow process, dictionary management, reporting, etc.
• Complete risk-based validation as per Techsol computer systems validation process and produce audit-ready validation documentation for 21 CFR Part 11 compliance
  Deliver a hands-on Argus Safety training for Ipca’s business users and application administrators
• Complete legacy case data migration using Techsol’s proprietary multi-phase, migration methodology to ensure data quality and integrity
• Conduct pilot testing of electronic submission with regulatory agencies
• Set-up post-implementation Argus Safety service desk for hypercare and ongoing support

With the successful implementation of Techsol’s AccelSafety, Ipca achieved following business outcomes:

• Primary objective and goal of having a state-of- the-art, fully integrated data-safety, e- submission and signal detection system was achieved
• The impact on business was immediate and significant. Efficiency of more than 60% improvement in meeting submission timelines and approximately 50% reduction in case processing times were observed
• With the utilization of e-Submission Gateway, the ICSR process was automated to provide timely ICSR submissions to FDA and EMA consistent with regulatory standards
• Now, Ipca could detect signals, uncover patterns, and perform/recognize trends on case data.
• AccelSafety was ready as a scalable cloud platform to address Ipca’s future growth
• 24X7 Techsol managed service desk was established to address all post-go-live support activities

GemVax were in need of safety solution as their products are ready to be marketed. They had a limited understanding of the overall process of implementing a safety systems application. The requirement was to manage the entire project to deliver a fully validated system before marketing of the approved products. The key challenges GemVax faced in preparing to marl‹et their approved products:

• Limited understanding of safety system implementation
• Implementing a fully validated safety system in time to market the drugs
• End-user training to work on the newly implemented system

Techsol worked with GemVax to manage the project and ensure delivery of all elements required to meet the business objectives.

• Post-delivery by Oracle, we fast-tracked implementation of Argus Safety v7.0.4.1 on Oracle cloud.
• Our team provided validation for the entire system to mal‹e sure the application was compliant with the regulatory rules/guidelines.
• We provided end-user training to ensure the application was used to its full potential, accurately.
• We provided post-implementation hypercare to GemVaH team ensuring dll their issues were resolved in a timely manner.

Efficient execution of the project brought many favourable results for the client:

• The safety system was ready before the product go-live and on-going study
• Fully validated system as per GAMP5 guidelines
• Reduction in human effort for case processing
• Regulatory compliant system with the ability to perform end-to-end case processing
• Increased audit compliance with more control over all pharmacovigilance activities and recording of all case processing activities