Guiding patients through adverse events and exposures from event initiation to resolution, supporting aspects like medical triage, poisoning management, patient education and ongoing follow-ups/monitoring

Providing guidance on regulatory requirements, preparing regulatory submissions and ensuring compliance with relevant regulations and guidelines

 Protecting the integrity of your product by delivering accurate, timely reports, fostering safety and providing responsible product management

Assessing and mitigating risk with our guidance on adverse event reporting obligations and methodological recommendations

Choosing the appropriate methodologies, statistical techniques and quality control measures to derive meaningful insights from your collected data

Designing scientifically robust studies and protocols with our expertise in study design, statistical analysis, regulatory compliance, and data collection

Leveraging our signal detection and data analysis tools to understand and properly respond to public health impacts of your drug or product

Tapping into our toxicological expertise to develop robust safety assessments to minimize risks for public health and environmental safety

Integrating our time-tested safety reporting intake processes with solutions for databasing and reporting

Robustly intaking Adverse Event/Product Complaint (AE/PC) data to reduce downstream effort for follow-up. Integrated transmission and reconciliation procedures support submission deadlines and regulatory audits with ease

All-in-one telephony services including local and international routing, multilingual support, unified communications and strong quality assurance

Facilitating timely and accurate reporting to regulatory authorities through the comprehensive assessments of product safety profiles

Offering highly configurable validated systems for Medical Information (MI), Adverse Event (AE) and Product Complaint (PC) intake alongside dedicated system administrators. This supports customizable solutions developed from industry standards and best practices

Customizing insights to provide real time visuals within an interactive dashboard. Identifying trends to support the evolution of customer needs and satisfaction

Streamlining integrations, most commonly content integration, and bi-directional CRM integration, with an emphasis on data integrity

Providing near-real-time product-specific and geographic-specific data with expert analysis and interpretation

Combining multiple data sources to strengthen findings, reduce the risk of misinterpretations and offer a comprehensive perspective on your study questions

Developing real-world studies designed to understand the effectiveness and safety of an approved drug

Interpreting and using the National Poison Data System (NPDS) database of America's Poison Centers

Monitoring scientific literature to identify relevant and current information related to pharmaceutical products on an ongoing basis

Comparing structured data to evaluate product outcomes  

Designing studies, analyzing data and developing manuscripts to ensure information is effectively communicated and disseminated. Analyzing and creating scientific messages to publish important results

Experts in generating materials, including adverse event reports, patient education materials, medication guides, signal detection and evaluation reports, which are accurate and easily understood by your target audience

Striving to connect industry, academia, and regulatory experts to discuss the latest real-world evidence in prescription drugs and treatments.

Providing guidance on regulatory requirements, preparing regulatory submissions and ensuring compliance with relevant regulations and guidelines

Expediting reviews and providing resources to ensure compliance and facilitate regulatory approval

Generating regulatory data, analysis and reports

Identifying, assessing and implementing measures to minimize product risks

Developing epidemiological studies, pharmacovigilance and surveillance systems to provide insights about abuse potential.

Providing refined tools to help you understand the overall safety profile of your product or drug

Addressing research questions with protocol development outcomes, design and methodology development to illustrate drug safety and efficacy

Planning, resourcing and risk management for Phase II - IV clinical trials

Providing a data-driven, patient-centric approach to operations related to recruitment, screening, engagement and retention

Offering data collection and analysis, biostatistics support, CRF development and database management

Supplying an expanded network of patients through decades of site network experience

Reviewing data collection and records to ensure data integrity and regulatory compliance