Bridging the gap between innovation, regulation, safety, and performance
Life Sciences & Healthcare
Navigating FDA and global regulatory frameworks for novel medical devices, pharmaceuticals, and combination therapies; devising testing beyond standards; developing innovative delivery systems, acceptable usage, and dosage; demonstrating comparative effectiveness and economic value.
Government Sector
Evaluating benefits, risks, and value of authorized Medicare-reimbursed drugs, devices, and procedures; assisting with validation of diagnostics and health technology assessments.
Consumer Products
Evaluating biocompatibility of wearables; analyzing sensitizing materials, including plastics, metals, and composites; assessing exposure toxicity risks; determining levels and safety of magnetic and radiation emissions.
Food & Beverage
Validating health claims for supplements and food; evaluating next-gen formulations and additives; supporting navigation of global regulatory frameworks; and more.
Industrial & Manufacturing
Assessing whether employees or the public are at risk of long-term health issues; verifying product efficacy; evaluating exposures from manufacturing processes and fate and transport for byproducts.
Boldly Navigate Unknown Territory with Confidence. Whether you're pursuing regulatory approval for a revolutionary diagnostic, pioneering a new medical device, spearheading novel pharmaceutical or combination therapies, Ä¢¹½tv thrives on solving unstructured problems. With deep expertise in human health, data sciences, epidemiology, pharmacoepidemiology, health economics, biomedical engineering, toxicology, we help you navigate uncharted territory in health sciences and healthcare.
health sciences , data sciences , information technology
How Can We Improve Health Care for the Elderly?
In 2020, when the COVID-19 pandemic took hold in the U.S., it became quickly apparent that nursing home residents, one of the country's most vulnerable populations, were at greatest risk. The U.S. public health infrastructure was, and largely remains, ill-equipped to mitigate disease outbreaks and monitor the safety and effectiveness of newly developed treatments.
What Can We Help You Solve?
We thrive on bringing data-driven and evidence-based approaches to unstructured problems in health sciences and pushing the boundaries of what's possible. Connecting decades of experience across industries, we stay agile and evolve our capabilities to see around corners, anticipate challenges, and mitigate them for our clients.
Biocompatibility & Biological Risk Assessment
Address biocompatibility challenges throughout the medical-device product lifecycle.
Clinical & Pharmacoepidemiology
Rigorous pharmacoepidemiology studies and clinical trials.
Chemical Toxicology & Health Risk Assessments
Exposure assessments, toxicity evaluations, and support for issues of toxicology and mechanistic biology.
Healthcare & Life Sciences Value & Outcomes Assessment
Strategic guidance for medical product value and access, including drugs, vaccines, and medical devices.
Health Risk Assessments
Identify risks, hazards, and liabilities to improve occupational health and safety.
Medical Device Evaluation
Sophisticated medical device evaluations for a vast array of applications.
Occupational & Environmental Epidemiology
Advanced epidemiological research and evidence-based insights from leading epidemiologists and biostatisticians.
Drug Safety & Risk Management
Determine the optimal strategies, methods, and solutions to align with specific products, patients, populations, and situations.
Wear & Biotribology
Conducting medical device wear testing, establishing wear test programs, and providing insights for regulatory requirements.
Real-World Data & Evidence Consulting
Leverage real-world data to improve healthcare decisions.
Biomedical Devices & Ä¢¹½tv
Our state-of-the-art biomedical evaluations are designed to enable decision making and power your product development lifecycle. Our unique multidisciplinary expertise and robust analyses can provide you with the insights needed to unlock innovation while keeping safety, performance, and regulatory compliance front and center.
Intentional Data Acquisition
Technology — and the data that can be acquired from it — is increasingly being applied directly to the human body. Our real-world data experts can not only help you design bespoke, human-centered studies to capture the right data, but lift meaningful insights from existing or acquired data sets, enabling you to close gaps in equitable representation and answer key questions about your product, process, workforce, and more.
