Reliable Pharmacovigilance Services
Track and record the effect of your licensed drugs; turn regulatory compliance into a strategic edge with our pharmacovigilance services. Collaborate with us now!
Biopharmaceutical entities constantly struggle to monitor and document the effects of their licensed and released drugs. To optimize drug acceptance and administration, they must ensure compliance with the distinct requirements of the geographical jurisdictions where they operate. The process is both tedious and resource-consuming, and, not to mention, unbudgeted when attempted in-house. As an offshore business partner with two decades of extensive expertise, we provide pharmaceutical companies, medical device manufacturers, and clinical research organizations with effective solutions to overcome these challenges. Contact our medical experts today to optimize drug safety and ensure absolute regulatory compliance in accordance with US FDA regulations.
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Pharmacovigilance Services We Offer
Our proficiency in regulatory compliance and risk mitigation helps us evaluate drug efficacy to safeguard patient safety. Delve into our diverse range of online pharmacovigilance services.
Individual Case Safety Reports (ICSRs)
We capture and analyze adverse events, ensuring regulatory compliance and enhancing product safety through precise and timely reporting.
Literature Monitoring
We scan medical literature globally to pick up safety signals. Through adequate monitoring, we help address instances of ADR. Our prime directive is to maintain compliance and form risk management strategies.
Aggregate Reporting
We compile comprehensive, regulatory-compliant aggregate reports, which provide invaluable insights into safety trends and product risk profiles to support strategic decision-making.
Signal Detection and Management
Detect and evaluate safety signals using advanced analytics to proactively mitigate risk and maintain product integrity in the market.
Risk Management Plan (RMP)
We develop and implement tailored RMPs that focus on identifying, assessing, and minimizing risks. Our drug safety officers do their best to address potential issues and safety concerns.
Pharmacovigilance Audit and Training
Our experts provide rigorous audits and training to improve your system's efficiency and ensure compliance with global standards.
Safety Database Solutions
We leverage specialized software and systems to record, manage, and analyze data related to adverse drug reactions. These databases store large volumes of data and ensure efficient data retrieval.
Medical Device Vigilance
Our experts enable you to stay compliant with evolving regulations by evaluating device safety and performance through vigilant post-market surveillance.
Regulatory Intelligence and Consulting
We collect and analyze regulatory information to evaluate its current and future implications on drug development or marketed medicinal products and healthcare devices.
Our Approach to Provide Pharmacovigilance Support
Signal Detection
Adverse Event Data Aggregation
Safety Data Analysis
Risk-Benefit Evaluation
Risk Minimization Strategy
Regulatory Safety Reporting
Pharmacovigilance Consulting Services for Managing Drug Safety
Need help managing and interpreting large data volumes generated from various sources? Make way for our consultants, let us guide you through the nuances of efficient data collection, analysis, and adverse event reporting. We provide expert advice on communication strategies for safety findings, a significant challenge in pharmacovigilance. Besides, we also assist clients in the strategic planning and execution of patient support programs to extend their safety monitoring beyond the post-marketing phase. Contact us now to schedule a free session with our drug safety associates.
Our Technical Competence
Audiences That Stand to Benefit From Our Services
Pharmaceutical Entities
Biotechnology Firms
Clinical Research Organizations
Healthcare Providers
Health Insurance Companies
What Sets Our Pharmacovigilance Outsourcing Company Apart?
Committed to delivering services that ensure drug and patient safety, we leverage our deep industry knowledge and advanced tools to help you meet global pharmacovigilance standards.
Extensive Global Network
After spending two glorious decades in the industry, we have become a part of the most impressive network of clinics, hospitals, research institutes, and regulatory authorities. Being a part of this extensive community enables us to enhance our surveillance coverage and response speed.
Process Optimization
We transform and optimize PV systems for our clients by using Lean Six Sigma methodologies. Partner with us today to minimize errors and do away with redundant processes.
Pharmacogenetic Monitoring
We come up with comprehensive processes to identify the pharmacogenetic markers of drug response, thus contributing to more personalized drug development and usage. Being able to predict individual responses reduces adverse effects and improves efficiency.
Advanced Web Scraping
We use the best and the latest AI-driven, NLP-powered tools to listen into social media conversations. By doing so, we stay on top of potential safety signals circulating in the public domain.
Improved Patient Safety
Our proactive systems can pick up the signs of ADR in the earliest days of a drug release. This allows us enough time to help our clients prepare for the situation. Based on our findings, you can decide whether to restrict the drug, recommend reduced dosage, or withdraw it altogether.
Detailed RMAPs
We do not stop at detecting early signs of drug failure. We work alongside you to come up with a quick and effective risk mitigation action plan that considers both patient safety and business impacts of permitting or withdrawing a drug, post-market launch.
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Additional Services We Offer
Streamline your healthcare processes to minimize claim denials and optimize your revenue cycle.
Enhance your financial performance and patient satisfaction, while accelerating cash flow and reducing operational costs.
Eliminate errors and speed up claim processing with our meticulous services to get timely reimbursements and improve cash flow.
Get strategic solutions for inventory management, prescription processing, and regulatory compliance with our comprehensive services.
Optimize Drug Safety Reporting with Custom Assistance
In the absence of comprehensive pharmacovigilance, global pharma companies would be in the throes of serious risks and adverse effects. From market reputation to patient safety, a lot rides on accurate and custom Phrase IV studies. Leverage the aid of some of the best industry experts, by partnering with us. Let us help you discover the most rare, adverse, and long-term drug reactions in time so that you can address them effectively, without taking a plunge on your credibility or your bottom lines. Make sure your other products don’t miss their time-to-market deadlines; reserve your focus on product development while we test, track, and monitor product performance for you.
Contact Us
Whom do we serve
Our Customers
Key Differentiators
AHIMA Healthcare Convention 2016
USA
Flatworld Solutions
116 Village Blvd, Suite 200, Princeton, NJ 08540
PHILIPPINES
Aeon Towers, J.P. Laurel Avenue, Bajada, Davao 8000
KSS Building, Buhangin Road Cor Olive Street, Davao City 8000