Ä¢¹½tv

We take your data management to the next level, arming you with evidence-based insights to make crucial decisions. Our collaboration spans data strategy, planning, implementation, and analysis. Ä¢¹½tv's cross-disciplinary teams can help you:

• Improve the quality of your data collection and mining techniques for better disease surveillance, healthcare analytics, health economics, and outcomes research
• Expand the scope of real-world evidence by identifying datasets that better represent the true diversity of your product's users
• Establish systems and dashboards to support your ongoing analytics needs
• Create integrations with third-party data sources to facilitate real-time updates
• Ensure private data stays private through effective management of HIPAA considerations

When you're designing new products or targeting new markets, ensuring you have the latest science and market knowledge is essential to guiding your decision making.

Our experts in engineering, materials science, public health, epidemiology, environmental health, drug discovery and development, pharmaceuticals, health economics, and human factors provide custom research and consulting, such as:

• Market analysis with quantitative and qualitative state-of-the-art reviews and meta-analyses of epidemiologic and clinical research for a particular disease
• Market access and health economics evaluations to capture holistic value of your product including clinical, humanistic, social and economic factors. 
• Preclinical support to ensure the safety and efficacy of your approach
• Clinical candidate selection based on potency, selectivity, safety, and efficacy
• Complex process modeling, representing diseases and care delivery, as well as multi-physics and advanced physiological models for innovative therapeutics and product-tissue interactions
• User needs and human requirements engineering to understand new market opportunities and help satisfy regulatory requirements

Ä¢¹½tv can help you enhance your product design efforts in multiple dimensions, ensuring you deliver on safety, efficacy, value proposition, and market potential.

Our experts provide innovation support for pharmaceuticals, medical devices, diagnostics, and digital therapeutics. From basic drug formulations to combination and innovative software-as-a-medical-device products, we provide targeted science and engineering insights to supplement your internal teams with elements such as manufacturing expertise, regulatory submission pathways, and more.

Get the exact help you need:

• Science-based strategy informed by landscape evaluations, technology assessment, and horizon scanning, using tools such as scenario planning, Monte-Carlo simulations, and decision analysis
• Material selection support based on design goals, indications for use, sterilization compatibility, biocompatibility, strength, and other criteria
• Physical design analysis, ensuring the therapeutic can meet the intended performance criteria, for example, as related to stress, corrosion-resistance, flow rates, and other factors. Our work often involves physical or computer-simulated analyses
• Human factors analysis, starting with formative testing of devices early in the lifecycle and including validation testing as part of the regulatory submission for the device
• Benefit-risk optimization, leveraging our multidisciplinary expertise to optimize design for creating shared value for patients, payers, providers, policymakers, and manufacturers

The road to market for innovative medical products is one of the most complex  — no matter what market you're targeting. From research and development to market access and post-market surveillance, Ä¢¹½tv can help ensure your team has the expertise needed to optimize efficiency and effectiveness.

Our regulatory experts can help you navigate the product review process and stay aligned with regulations and current guidance across the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), EU Conformitè Europëenne (CE), and others. Additionally, our human factors experts can help you create clear, understandable product labeling.

With our broad experience across medicine, pharmaceuticals, medical devices, combination products, and diagnostics, Ä¢¹½tv can provide:

• Patent research
• Communications/liaison with regulatory agencies, including pre-meeting documentation and submissions
• Device testing and regulatory science
• Labeling/human factors
• Safety assessments
• Release specifications
• Chemistry and manufacturing controls (CMC)

Get clear scientific guidance about how your product may impact human health, and a thorough understanding of its potential benefits, risks, and value across your target populations and use cases.

Our specialists in epidemiology, mechanistic biology, biostatistics, biocompatibility, and health economics can help you develop evidence on how your product will work in the real world. We've conducted detailed studies on the health impacts of hundreds of products, giving us an unmatched breadth of experience across the most challenging clinical questions in life sciences and healthcare.

Real-World Evidence

Ensure you are getting the most realistic picture of unmet medical needs and comparative effectiveness in your target patient populations. We provide expertise for the sourcing, integration, analysis, and visualization of real-world data (RWD) to generate regulatory-grade and payer-relevant real-world evidence (RWE). Our interdisciplinary approach leverages innovative epidemiologic methods as well as artificial intelligence, machine learning, and custom software development. We also provide data quality assessments, remote data collection, data curation, and integration to maximize validity, reliability, and utility of RWD.

Pharmacoepidemiology & Health Services Research

Answer the thorny questions that arise throughout your product's lifecycle. Our epidemiologists, outcomes researchers, health economists, and experts in electronic health records, collaborate to design and conduct complex studies, whether based on retrospective, prospective, or hybrid methods. Our approach includes traditional, pragmatic, and innovative designs, marrying the principles of causal inference, and data science. 

Biocompatibility Evaluations & Toxicological Risk Assessments

Identify and evaluate human health issues related to your products. We employ both standardized and custom methods to gather relevant information and provide deep expertise on preclinical biocompatibility testing, assessment of product impurities and contamination, and toxicological risk assessments.

Biological Methods

Our scientists provide expertise on the design, development, and execution of biological assays for diagnosis of disease, monitoring of clinical trial endpoints, or identification of contamination.  We also provide assessments of the risks of existing assays for failures, as part of due diligence activities or in the context of regulatory submissions. 

Identify and limit potential areas of risk to maintain compliance and minimize liability. We work with clients to develop risk assessment methodologies that address issues ranging from product liability to contamination mitigation to worker safety. Our experience across life sciences and healthcare companies gives us unique insights into the sources of potential risks and the most effective ways to address them.

We prioritize going beyond subjective analysis to put real numbers to your risks. We develop actionable recommendations, grounded in science, including assessments such as:

• Risk/benefits of your products
• Failure modes and effects analysis (including DFMEA and PFMEA) of hazards
• Cybersecurity, including protection of HIPAA protected data
• Toxicological risk assessments, including biocompatibility evaluations

When there's an issue with a product that's on the market, you need clear answers to quickly assess:

• What are the safety issues? How severe are they? What is the root cause? 
• What can be done to address them (e.g., product, process, or labeling improvements)?
• Should the device be recalled? What can/must be done for existing users?
• What should be communicated to governmental or regulatory agencies, such as the FDA and the public?

Whether it's a device, a diagnostic test, or a treatment, we help you determine the best corrective and preventive actions (CAPA) to stay in compliance with regulatory agencies and get back to business — as quickly and painlessly as possible.

Manage the environmental impact of your manufacturing processes, operations, and products with expert scientific guidance.

Our multidisciplinary scientific and engineering teams can give you a clear understanding of how your activities may affect the air, soil, and groundwater near your facilities and through your products — as well as help you identify and validate alternative materials and processes — by answering questions such as:

• How should you dispose of manufacturing waste and by-products?
• Are there special considerations for your product's disposal?
• Do your products or processes leach substances like endocrine disruptors?
• Are you operating in an environmentally sustainable manner?
• Are your products meeting UN sustainability goals for health equity?

Clients turn to Ä¢¹½tv when they need to objectively understand what went wrong and why. We offer extensive experience in matters involving life sciences, intellectual property, and patent infringement, personal injury, toxic tort, international arbitration, insurance disputes, and breach of contract.  

We have specific expertise with investor valuation claims based on conducting due diligence or meeting FDA milestones. We've also helped clients resolve claims related to "best endeavors" to carry out transfer technology during an acquisition, such as what was technologically feasible, what was known or not known in the scientific and medical communities, and what types of industry standards existed at particular moments in time.

Ä¢¹½tv also has significant experience supporting internal company investigations involving whistleblower allegations related to medical product performance and safety, helping clients meet patient, market, and regulatory expectations. Specific examples of support we have provided include choice of testing methods, analysis of results, and assessment of relevance of particular regulatory requirements and industry standards. Working closely with internal and external counsel, Ä¢¹½tv's multidisciplinary team of scientists and engineers can rapidly evaluate the basis of whistleblower complaints and their potential impact on current and ongoing operations. Our team provides strategic insight from a regulatory and technical perspective, conducts targeted product evaluations and data analysis, and supports interactions with relevant government agencies including the U.S. Food and Drug Administration and the U.S. Department of Justice.  Additionally, evaluating allegations in the context of more broadly available product safety information can inform stakeholders as investigations are conducted to provide input for strategic decisions. 

Ä¢¹½tv scientists and engineers represent the science at dispute proceedings by bringing clarity and precision with a knack for explaining complicated topics in understandable ways for judges and juries. We can assist you across all phases of disputes, including pre-litigation, fact-finding, litigation expert testimony, and arbitration.