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Global Literature Surveillance Project

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Our Approach

Transition and Onboarding

Initial Team and ETLQ Team: Deployment of an Empowered Training, Learning & Quality (ETLQ) team which comprised some of our existing team members and new hires whose experience exceeded the required minimum. This team remained active throughout the project implementation to be the group to provide training & guidance, to review complex cases, and to share learning during daily/weekly huddles.

Rapid Recruitment: Onboarding of experienced safety associates in the team and deployment of Drug Safety Physicians to guide/mentor the team and develop training protocols

Robust Communication: Identified and deployed SMEs for each functional area: project management, technical leadership, quality function, technology function, commercial/finance etc. to ensure rapid progress in the project deployment.

Stabilization Approach and Governance

Hands on Training: Team Training on software platform with review of over 60,000 publications in the test environment during training-mentorship program

Hands on practical pre-Go-Live simulation: Volume based Go-Live simulations for 2 scenarios – 100% volume. Executed successfully by Soterius with feedback and learning sessions for both simulations.

Mentorship Circles: 1 SME for 3-4 personnel providing close personal support and supervision.

Project Collaboration: Daily Huddles, regular interaction amongst the Soterius SMEs and Client’s SME to discuss urgent issues and meetings to discuss project progress

Governance: In-Person Governance meetings to monitor pilot results, feedback on process improvements, deployment preparation and Go-Live.

Outcome

Successful project implementation

100% compliance to the 5 key milestones (including hiring, training, pilot phase) set up by the client till Go-Live.

Performing global literature surveillance with over 150,000 literature publications annually with 100% compliance to timelines and 99% quality KPIs.

Smooth Go-Live and transition with no down-time or delays

About Soterius

Soterius is a strong team of pharma professionals who design customized, innovative, and cost-efficient processes for clinical safety, pharmacovigilance, and medical affairs. Our deep industry knowledge and up to date insights let us combine agile, people powered intelligence in pioneering customer centric solutions. Our innovative technology solutions include engagement tools and communications platforms to create a unified and compliant medical access facility. With a strong global presence, we provide comprehensive clinical and post marketed safety services, that include aggregate report writing, signal detection and management, global literature surveillance, risk management, case processing and regulatory reporting. We use state-of-the-art technologies to solve complex safety operations problems, be it case processing, intake, site reporting for clinical trials, or literature search and management. We have one of the most accurate solutions for case intake and case processing using AI.
We support companies from the initial development stage of a drug/vaccine to the approval and ultimate marketing of the therapy, supporting ongoing operations and regulatory commitments globally.

Authors

Dr. Parul Singla

Dr. Parul Singla

Sr. Director, PV Operations

Parul is an M.D. in Pharmacology with over 15 years of experience in pharmacovigilance and clinical research. He has managed the expectations of multiple clients on quality and compliance for complex analytical work in medical safety such as signal management, risk management, aggregate report preparation, and on the immediate impact case management functions. He has participated in over 10 regulatory inspections with successful outcomes. Parul has experience across pre and post marketing pharmacovigilance including signal management, aggregate report, ICSR case processing, SAE/ SUSAR processing and reporting, analysis of similar events, safety management plans, SAE reconciliation plan, etc. In his previous role, he headed the pharmacovigilance department of a global pharmaceutical company where he successfully accomplished global harmonization of the pharmacovigilance function to create a Centre of Excellence.

Disclaimer

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