Accurate processing and timely submission of ICSRs and aggregate reports, fully aligned with global regulatory requirements to strengthen drug safety monitoring.
Preparation of post marketing periodic safety reports such as PADERs/PSUR/PBRERs/ACO.
Signal Management
Systematic detection, assessment, and monitoring of safety signals to enable early risk identification and proactive patient safety measures.
Literature Monitoring
Structured surveillance of global scientific literature to identify safety information, ensuring timely detection of adverse events and regulatory compliance.
Risk Management
Development and implementation of Risk Management Plans (RMPs) and additional safety measures to minimize drug-related risks throughout the product lifecycle.
Pharmacovigilance Audits
Comprehensive audits to evaluate compliance, identify process gaps, and optimize pharmacovigilance systems in line with international standards.
Medical Information Contact Center
Dedicated support services providing accurate, timely, and compliant medical information to healthcare professionals, patients, and regulatory authorities.
Clinical trial Management
Comprehensive Support Across Every Trial Phase
Project & Site Management
End-to-end project and site management to ensure trials are planned, executed, and monitored efficiently. We coordinate across stakeholders to maintain timelines, quality, and regulatory compliance.
Ethics Committee Services
Expert coordination with ethics committees to uphold regulatory requirements and ethical standards, with patient rights and safety as the top priority.
Clinical Trial Monitoring
Rigorous monitoring to ensure protocol adherence, accurate data collection, and quality oversight—delivering reliable outcomes and regulatory compliance.
Safety Management Plans
Development of tailored safety management plans outlining procedures for risk detection, assessment, and reporting—ensuring proactive safety oversight throughout the trial.
Safety Reports Processing & Submissions
Preparation, processing, and timely submission of safety reports to regulatory authorities with accuracy, transparency, and compliance.
Safety Review Committees
Support in establishing and managing safety review committees, enabling expert evaluation of safety data and informed, timely decision-making.
Medical and Safety Writing
Comprehensive Writing Support for Clinical & Regulatory Needs
Clinical Study Protocols & Submissions
Preparation of clear, compliant study protocols and submission documents that meet global regulatory standards and ensure smooth trial execution.
Development of patient-centric materials that promote understanding, participation, and transparency in clinical trials.
Investigator’s Brochure & Review Materials
Creation of comprehensive investigator brochures and supporting review documents to provide investigators and stakeholders with detailed study insights.
Development Safety Update Report (DSUR) / Annual Safety Report (ASR)
Accurate and timely preparation of DSURs and ASRs to ensure regulatory compliance and continuous safety evaluation.
Clinical Study Reports (CSR), Clinical Overviews (CO & NCO)
Delivery of high-quality CSRs, Clinical Overviews, and Non-Clinical Overviews, presenting data with clarity to support regulatory submissions and decision-making.
Risk Management Plans (RMPs) & aRMM Documents
Design and drafting of RMPs and additional Risk Minimization Measure (aRMM) documents to proactively address and manage drug safety throughout the product lifecycle.
Clinical data sciences
Transforming Data into Reliable Insights
Clinical Data Management
Comprehensive data management services ensuring accurate collection, validation, and reporting—delivering reliable, high-quality datasets that support compliant and successful clinical research.
Biostatistics
Robust statistical design, analysis, and interpretation that convert complex clinical data into meaningful insights, driving sound decision-making and regulatory success.
Data Analysis & Reporting
Tailored data analysis and reporting solutions that provide sponsors with clear, actionable results—enabling confident research, regulatory submissions, and strategic planning.
