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. Without a strong commitment to drug safety and pharmacovigilance, the health and wellbeing of patients could be put at risk, and the reputation and success of the pharmaceutical industry could be negatively impacted. By continuously monitoring the safety of drugs, pharmacovigilance systems help to identify and mitigate risks, and to ensure that patients receive the benefits of taking a drug without being exposed to undue harm. It is for these reasons, Regulatory authorities require that pharmaceutical companies monitor the safety of their medicinal products and report any adverse events for public awareness and implementing pre-cautionary measures.
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.
Our Capabilities
- Team has expertise to perform global safety data management and regulatory reporting (FDA, EMA, PMDA, TGA, DCGI, etc.)
- Our unique PVPivot solution offering aims at delivering flexible and cost-effective Pharmacovigilance & Medical Information services
- We use the industry leading Oracle Argus Safety and Empirica Signal platforms to timely complete case processing, medical review and regulatory submission
- Our team is specialized in post-marketing surveillance reporting (RMP, PSURs, PBERs, PADERs, etc.) and safety signal management
- Clients leverage our Compier platform for PV process digitalization and compliance oversight (SDEAs, Aggregate Reporting, Literature Screening, etc.)
- All our PV processes are executed using our stringent QMS policies and SOPs to ensure quality and compliance
Drug Safety and PV Functional Services
At Techsol, we are committed to providing high-quality pharmacovigilance services that meet the needs of our clients and ensure the safety of patients right from clinical development to post-marketing. Following are the key drug safety and PV focus areas where we actively support biopharma, generics, and medical device companies.
Drug Safety and Signal Management Technology Solutions
As a trusted Oracle Partner, Techsol has vast experience in delivering Oracle’s comprehensive suite of Safety and Signal management applications to global clients. If your company is seeking to freshly implement, or migrate from another safety system to Oracle Argus Safety, we have the expertise to complete system implementation, configuration setup, system validation, application upgrade, and provide SLA-based support.
Since 2010, we have worked extensively with all the Oracle Argus Safety Global modules (Standard and Enterprise Editions), Oracle B2B and Axway E2B E-Submission Gateways, Oracle Empirica Signal & Topics. You can choose to use the Oracle Safety Cloud or adopt Techsol’s AccelSafety cloud which is powered by Oracle Argus Safety.
PV Operations Digitalization & Compliance Oversight
Pharma companies are often challenged with disconnected pharmacovigilance processes, manual preparation of safety reports, maintaining dozens of operational trackers in the form of multiple spreadsheets. This results in loss of process efficiency and creates compliance gaps.
With the objective of simplifying PV Processes, we at Techsol have engineered Compier, to help sponsor companies manage different vendors, partners and affiliates and establish Digital Quality and Compliance Oversight across all pharmacovigilance processes.
The Compier platform is a next-generation, purpose-built process orchestration and compliance governance solution to streamline, track and report the outcomes of PV operations and related cross-functional activities. It helps sponsors to digitalize PV workflows and take informed decisions using actionable insights.
We offer all our PV functional services by leveraging Compier to enable sponsors gain maximum efficiency and compliance.
