Leverage Our Expertise for Proactive Drug Safety Management and Pharmacovigilance
Patient Safety and well-being is one of the most important priorities of every pharma company. Techsol provides advanced business process solutions to manage Drug Safety throughout the product lifecycle. We follow stringent, regulatory compliant Pharmacovigilance procedures to monitor and manage the safety profile of any medicine with effective risk management and informed decision making.
With our presence across the globe our global pharmacovigilance team is capable of handling large case volumes, complex multi-center and multi-national safety operations with a combination of offshore and onshore teams. We offer independent PV Services or integrated with global medical information and regulatory services.
Services We Offer
With Patient safety as the highest priority for pharmaceutical and biotechnology companies, the pharmacovigilance (PV) team has the crucial responsibility to identify, collect, and process the Individual Case Safety Reports (ICSRs) with confidentiality and report to regulatory authorities within the stipulated timelines.
Techsol has more than a decade experience in case processing and regulatory reporting services. With our combination of powerful technology and functional capabilities, we deliver high-quality functional services using our readily available validated AccelSafety database.
Our Case Processing & Regulatory Reporting Services:
- Receipt and triage of initial and follow-up cases SAEs, AESIs, SUSARs, ICSRs, regulatory cases
- Data entry
- MedDRA coding
- Narrative production
- Analysis of Similar Events
- 100% case quality control (QC)
- Medical assessment
- Case closure and locking
- Generation and distribution of follow-up queries
- Global expedited case reporting
- EudraVigilance reporting using EV Web and E2B (R3) compliance
- Reporting to Competent Authorities, Ethics Committees/Institutional Review Boards and Investigators
- Reconciliation with external data collection partners (CROs, affiliates, partners, etc.)
With our innovative solutions such as Sentinel IRT with Mailbox, Sentinel ICSR QA and Sentinel L2A Case Management, we not only provide the process expertise but also use the best of technology to add value to clients.
According to GVP Module VI, every Marketing Authorization Holder (MAH) should have a dedicated Literature Monitoring program as part of safety monitoring of medicinal products to regularly search for articles in the literature databases and report adverse events. Non-compliance to this requirement may result in challenges like missing relevant ICSRs, inadequate aggregate reporting, missing safety signals and a major audit finding leading to withdrawal of the drug from the market.
Techsol’s expert PV Team can support you with Literature Screening and Monitoring to ensure that your Pharmacovigilance (PV) program adheres to the global regulatory requirements. With our proprietary Sentinel Literature Screening module, we offer clients an AI based Literature Screening with Duplicate Check module and that can seamlessly integrate with Medline, Ovid, Embase and PubMed databases.
Our end-to-end Periodic Aggregate Safety Report services includes planning, time management, data request, writing, quality control, communication and evaluation which is delivered by our experts who analyze and prepare the following:
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Development Safety Update Reports (DSURs)
- Risk Management Plans (RMPs)
Additionally, we offer clients our Sentinel Aggregate Reports module that automates the complete regulatory reporting lifecycle management from pre-approval to post-approval of medicinal products with features like Digital Authoring, Collaborative Review and Insights & Analytics.