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Cerner Enviza
Cerner Enviza is listed as a consultant research supplier in the Scientist.com network, with 1 site in 1 country.
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Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Consultant
Clinical Consulting
- Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.
- Study Budgeting Consulting Request for Consulting Services
- Support Staff Recruitment Recruit nurses, clinical staff, certified clinical research coordinators and research support staff.
Clinical Trials
- Clinical Trial Risk Management Plan that maintains treatment quality throughout lifecycle and improve decision making.
- Prospective Explorative Studies Conduct a prospective exploratory study to assess the safety and efficacy of a test drug during clinical trials.
- Study/Site Feasibility Study Explore and test study practicality.
Data Science/Bioinformatics
- Biostatistical Design Use statistics to ensure appropriate pre-clinical and clinical study design.
HEOR
- Clinical Outcome Assessments (Non-Patient Reported) Measure a patient's symptoms, mental state and level of disease condition-related impact on daily life.
- Clinical Outcomes Measures patient's symptoms, mental, or physical effects of a disease or condition on how the patient functions, recorded by practitioner, provider, or instrument (not by patient).
- Comparative Effectiveness The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.
- Cost Benefit Analysis Economic evaluation in which costs and benefits (outcomes) are expressed in monetary units, to determine if the benefits of an intervention outweigh the costs.
- Cost Effectiveness Analysis Compare alternative treatments that lead to similar health outcomes.
- Decision Analytic Modeling Assess effects, costs and economic outcomes of treatment. These include cost-effectiveness models and budget impact models.
Show all 13 in HEOR
- Health Economics and Outcomes Research (HEOR) Evaluate data collected during drug development to maximize the value of a therapeutic product.
- HEOR Adherence Studies Strategy or study that assess extent to which patients or subjects follow recommendations for prescribed intervention; may include compliance assessment, as well as reasons related to actual or potential non-adherence.
- Patient Reported Outcomes (PRO) Assessment of health outcomes directly reported by the patient who experienced it, without interpretation of the patient's response by a clinician.
- Patient Treatment Patterns Assessment of treatment processes and patterns within clinical practice.
- Resource Utilization Descriptive and/or analytical review of a treatment that investigate the marketing, distribution, prescription, and use of drugs in populations. Endpoints to be assessed are the medical, social, and economic outcomes.
- Systematic Literature Review Summarizes the results of research (that meet pre-defined eligibility criteria for inclusion) and provides a high level of evidence on the outcomes assessed.
- Therapy Switch Insight into the reasoning of patients switching treatments and the outcomes of the switch.
Show all 88 services
Market Access
- Communication & Advertisement Distribution of a range of materials, through various communication channels, to highlight a message containing scientific-related topics
- Emerging Market Opportunities Analyze risks and opportunities in new markets and ensure patients have timely and continued access to new treatments.
- Formulary & Reimbursement Strategy Develop strategy and narrative to gain formulary access on insurance plans.
- Health Technology Assessment (HTA) Preparation/Strategy Dossier Development Perform evidence preparation and/or create strategies for the systematic evaluation of the properties, effects, and/or impacts of health care technology.
- Health Technology Assessment Submission (HTA Submission) Analyze the medical, social, ethical, humanistic, and economic considerations of a drug, medical device, or clinical procedures. Submissions are sent to regulatory agencies with different requirements that govern...
- Market Access Materials Find general strategies and methods used to market a pharmaceutical product or device.
Show all 11 in Market Access
- Market Research & Business Intelligence Run market feasibility studies, establish customer needs, improve product performance and analyze competition.
- Marketing and Commercialization Identify, promote and prove the value of a particular drug to key stakeholders.
- Pricing Strategy Develop value story tailored to a payer audience that will determine the appropriate price for treatment.
- Value Based Agreements or Outcomes-Based Contracts Collaborate with payer or provider to develop a reimbursement plan outside of the traditional fixed cost-per-unit that ties reimbursement or price to actual health outcomes.
- Value Dossiers Development Summary document that presents clinical, economic, and humanistic value of an intervention and associated disease state with the supporting evidence, formulated from the perspective of a particular stakeholder...
Medical Communications
- Abstracts Request services related to the writing and review of abstracts
- Medical Literature Reviews Systematic searching, appraisal, and synthesis of published scientific literature to generate evidence-based reports on a specific topic, disease, or treatment.
- Medical Publications Make clear and accurate presentations of scientific and technical data.
- Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.
- Poster Design and Development Design and Develop Posters for Poster Symposiums and conferences to effectively convey science information.
- Publication Writing Create further publication documents. Investigational device exemptions (IDEs) BLAs, MAA, PMA, eCTDs, informed consents, CMC and manufacturing reports, orphan drug designations (ODD), briefing books.
Medical/Commercial
- Health & Pharmacoeconomics Identify, measure and compare the cost-benefit ratio of products and services.
- Life Cycle Assessment (LCA) Analyze the lifecycles of the products and services with regard to their environmental impacts.
Old Category HEOR, RWE, Market Access
- Health Technology Assessment Submission (HTA Submission) (DUPLICATE) Conduct a multidisciplinary process that determines the value of a health technology through different points in its lifecycle.
- Non-Interventional Studies Examine different aspects of drug usage, including efficacy and safety, under real-life conditions.
- Patient-Reported Outcome Studies Get self-reported information regarding the personal health status of an individual.
- RWE/RWD Enriched Studies Combine different methodologies (retrospective, prospective, registries, chart or claims review, electronic medical/health records) to gain insights into real world patient behavior or drug use.
Real World Evidence & Data
- Claims Data & Database Analysis Analysis of care cost and quality.
- Claims Data - Billing Includes patient demographics, insurance status, geographical location, among others.
- Claims Data - Medical Includes hospitalization,physician visits,emergency department visits. May or may not include laboratory information including resource utilization, costs or charges, as well as ICD-9 or 10 codes.
- Claims Data - Pharmacy Includes medications, prescription orders, payment submissions, patient adherence, among others.
- Clinical Data Registry A study or collection of data regarding the health of patients and the care they receive over different time periods.
- Clinical Phenotype Data Obtain phenotypic data and observations on patients such as the clinical manifestation of the disease, clinical and behavioral parameters, symptoms, and laboratory test results.
Show all 33 in Real World Evidence & Data
- Data Asset Validation Tools for validating that patient data and source has been accurately recorded.
- Data Merging Tools for combining various data sets into a single data set. Includes data consolidation.
- Exploratory Study Explore study design, outcomes, data-collection method, and selection of population for a topic that needs more research information.
- HealthVerity - Health Data Platform HealthVerity platform serves as the foundation for the rapid creation, exchange and management of healthcare and consumer data. Through best-in-class identity resolution and matching capabilities, increased...
- Meta-Analysis Use quantitative statistical approaches to pool results across multiple studies to improve power or resolve uncertainty; may be used in conjunction with a systematic review.
- Multi-Source Data Pools Multiple data sources aggregated into singular platforms for analysis. May or may not include real-time analytics capabilities.
- Non-Comparative Study Assess an intervention using a single arm study design (without a control or comparator group).
- Patient Reported Outcomes (PRO) Databases Database or collection of data related to health outcomes directly reported by the patient who experienced it, without interpretation of the patient's response by a clinician or anyone else.
- Pragmatic Clinical Trial Randomized trial comparing two or more treatments in a real world setting. The trial possesses minimal exclusion criteria and closely follows the procedures of the clinical practice in order to mirror clinical care...
- Pregnancy Registries Database containing, through utilizing observational research methods, standardized data about women taking medication or vaccines while pregnant. Data may also collected on the newborn.
- Real World Evidence (RWE) Studies Studies (prospective or retrospective) utilizing data obtained from "real world settings" , and is outside the tight controls of a clinical trial design.
- Real-World Data Acquire real-world data from patients' electronic medical records including clinical information generated during the course of healthcare.
- Real-World Evidence Acquire clinical data from patients' medical records to analyze trends and the frequency of occurrence of different medical conditions.
- Registries - Disease Database containing, through utilizing observational research methods, standardized data about patients who have the same disease.
- Registries - Patient Database containing, through utilizing observational research methods, standardized data about patients who have the same condition, disease, or exposure and is used to evaluate an outcome
- Registries - Product Includes specific information about a product of interest, route of administration, dose, duration of use, start and stop date.
- Retrospective Exploratory Studies Retrospective exploratory studies
- RWD - COVID-19 Data from COVID-19 patients, can include diagnosis, treatment, among others.
- RWD - Diagnostics/Laboratory Includes information on laboratory procedures/results.
- RWD - Electronic Medical Record (EMR) Digital version of a patient's medical or health chart containing demographic, clinical, medical, and other treatment information.
- RWD - Genomics Genomic data collected from a patients with different diseases, can be derived from a range of sources.
- RWD - Oncology Data from oncology patients, can include clinical treatment, diagnosis, among others.
- RWD - Rare Diseases Data from patients with rare diseases, can include clinical treatment, diagnosis, among others.
- RWD - Wearables Data gathered from sources including pedometers, mobile devices, smart watches, among others.
- RWE/HEOR/Market Access Safety Surveillance Monitor safety of treatment and determine methods to identify adverse events early
- RWE/RWD Observational Research Research method for documenting clinical, economic, and or humanistic outcomes of actual medical practice absent the constraints of a more formal experimental design. See also Pragmatic Clinical Trials.
- Secondary Real World Evidence Analyze clinical trial data.
Regulatory Affairs
- Life Cycle Management Plan and strategy of the data collection and information throughout the different phases of product development (portfolio assessment, pre-clinical trials, clinical trials, pre-authorization, post-authorization, and RWE)
- Medical Labeling Design and create medical labels that accurately reflect purpose, precautions and other information.
- Patient Risk Management Identify, contain, and manage risks related to patient safety.
- Period Benefit Risk Evaluation Report (PBRER) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report
- Periodic Safety Update Report (PSUR) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report
- Post Authorization Efficacy Study (PAES) Answer uncertainties in efficacy of treatment, and improve understanding of treatment and the benefit-risk profile. These studies are specifically asked for by European Medicines Agency (EMA) to continually grant...
Show all 11 in Regulatory Affairs
- Post Authorization Safety Study (PASS) Evaluate the safety, benefit-risk profile, and risk management of a treatment. These studies are specifically asked for by European Medicines Agency (EMA) and they can be mandatory or voluntary.
- Post-authorization Safety Studies Research efforts conducted after a drug has been approved for market to monitor its safety profile in the general population. These studies aim to identify, characterize, or quantify potential adverse effects...
- Risk Benefit Assessment Determine ratio of treatment risk to the potential benefits.
- Risk Evaluation & Mitigation Strategy (REMS) Evidence required by FDA to support the benefit of treatment outweighs the risks. Purpose of REMS is to prevent, monitor, and manage serious risk by informing, educating, and reinforcing actions to reduce frequency...
- Safety Signals Early indication that a new or unknown adverse event occurred that may be caused by treatment and investigation is needed to determine a causal relationship. Can be investigated through spontaneous reports, studies...
Other services
- Observational Research Gain valuable insights into the association between a drug treatment and its outcomes such as long-term effectiveness and safety.
- Website
- www.cernerenviza.com
Where it operates
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United States 1 site
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