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YOLARX Consultants
YOLARX Consultants is listed as a small business 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: Small business
Clinical Trials
- Clinical Trial Design Develop study-related protocols, case report forms (CRFs) and database tools for records management.
- ePRO - Electronic Patient-reported Outcome Patient reported outcome collected by electronic methods.
- Study/Site Feasibility Study Explore and test study practicality.
Data Science/Bioinformatics
- Discovery Statistical and Mathematical Modeling Use mathematical variables and equations to establish relationships between data.
- RWE/HEOR Data Science and Modeling A process that helps make sense of your clinical data
- RWE/HEOR Drug/Therapy Discontinuation Analysis An analysis to understand patient behavior. Are the drugs taken on time, do the patients discontinue use, and if so how long after starting, etc.
- Translational Data Knowledge Extraction Analytical approaches to extract data from different sources like publications, databases, etc.
HEOR
- Burden of Illness/Disease Strategy and study related to assessing the impact (economic, non-economic) of disease on health outcomes in a country, region, community, patient, or health system.
- 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 Effectiveness Analysis Compare alternative treatments that lead to similar health outcomes.
- Health Economics and Outcomes Research (HEOR) Evaluate data collected during drug development to maximize the value of a therapeutic product.
Show all 12 in HEOR
- 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 89 services
Market Access
- Communication & Advertisement Distribution of a range of materials, through various communication channels, to highlight a message containing scientific-related topics
Medical Communications
- Abstracts Request services related to the writing and review of abstracts
- Literature Audits A systematic review and assessment of all published and unpublished scientific literature related to a product or therapeutic area for compliance or strategic purposes.
- 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.
Show all 8 in Medical Communications
- Protocol and Study Reports Write protocol and study reports, specifically relating to the drafting, writing, and editing of Clinical Safety Reports.
- Review Article/ Submission Drafting and managing the process of submitting an objective, comprehensive summary of the current literature on a disease or treatment area to a peer-reviewed journal.
Old Category HEOR, RWE, Market Access
- 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.
Pharmacovigilance
- Aggregate Safety Data Review Cumulative summary of safety information regarding the collection, analysis, and submission of aggregated safety data to health authorities at specified intervals.
- GxP Compliance Monitoring Ensure products or services adhere to a set minimum standard.
- Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs) 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.
- Pharmacovigilance Literature Surveillance Conduct systematic and ongoing review of scientific and medical literature to identify new information about the safety profile of a drug. This process is crucial for detecting adverse drug reactions (ADRs) that may...
- Risk Management Plans (RMPs) Develop Risk Management plans (RMPs) that include information on a medicine's safety profile and plans for further pharmacovigilance activities designed to gain greater knowledge. These documents also explain how...
- Safety Advisory Committees Collaborate with global experts to support safety surveillance monitoring and provide guidance on the safety of medicines and vaccines.
Show all 7 in Pharmacovigilance
- Signal Detection and Management Capture pre-determined safety signals or indicators from a variety of sources to ensure the safety of the product post clinical trial. This includes the review of various sources such as ICSRs, EVDAs, FAERS, and other...
Primary Market Research
- Adherence, Satisfaction, and Switch Behavior Studies Explores factors driving treatment compliance, satisfaction, and switching behavior. Guides patient support initiatives and product differentiation.
- Advanced Analytics (Regression, Clustering, Factor Analysis) Applies complex statistical techniques to uncover hidden relationships and drivers. Generates predictive insights to inform decision-making and optimization.
- Competitive Landscape Research Maps competitor products, positioning, trial activity, and perception among stakeholders. Delivers inputs for SWOT analysis and differentiation strategy.
- Data Cleaning and Statistical Modeling Prepares raw datasets for analysis through validation, normalization, and advanced modeling. Ensures accuracy and enables robust, reproducible insight generation.
- GDPR, HIPAA, BHBIA, EphMRA Compliance Ensures compliance with data privacy, ethical, and regional marketing research regulations. Mitigates legal risk and builds trust with participants and clients.
- Payer and HTA Expectations Research Engages payers and HTA bodies to uncover evidence needs, pricing thresholds, and access drivers. Informs clinical and economic evidence generation planning.
Show all 8 in Primary Market Research
- Product Landscape and Unmet Needs Reports Synthesizes secondary data and expert input into landscape maps and gap analyses. Informs asset development and positioning.
- Sequential qual-quant studies Combines initial qualitative exploration with follow-up quantitative validation. Ensures both depth and scale in evaluating concepts, needs, or strategies.
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.
- Cohort Study Investigating the causes of disease to establish links between risk factors and health outcomes.
- Exploratory Study Explore study design, outcomes, data-collection method, and selection of population for a topic that needs more research information.
Show all 28 in Real World Evidence & Data
- 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.
- 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...
- Predictive Analytics Variety of statistical techniques from data mining, predictive modeling, and machine learning, that analyze current and historical facts to make predictions about future or otherwise unknown events.
- 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.
- Quantitative or Qualitative Research Either to understand concepts, thoughts, or experiences with qualitative research or to quantify the problem by generating numerical data or data that can be transformed into usable statistics with quantitative research.
- 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 - Electronic Medical Record (EMR) Digital version of a patient's medical or health chart containing demographic, clinical, medical, and other treatment information.
- 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.
- RWE/HEOR Data Analysis Analysis that helps you make sense of your RWE/HEOR data
- 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)
- 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...
- 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.
Show all 11 in Regulatory Affairs
- 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...
- Regulatory Submission Documents Request services related to the submission and writing of New Drug Applications (NDA), Investigational New Drugs (INDs), and Investigator Brochures (IB) to the FDA and other regulatory bodies.
- 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...
Regulatory Consulting
- Toxicology Data Review Identify relevant toxicological endpoints for “No Observed (Adverse) Effect Level” (NO(A)EL) or “Lowest Observed (Adverse) Effect Level” (LO(A)EL).
Scientific Data Services
- Bayesian Statistics Extract information from data sets that are subject to error or noise to see unobserved possibilities.
- Multivariate Analysis (MVA) Analyze datasets with three or more variables simultaneously to discover hidden patterns, correlations, and underlying structure
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
- yolarx.com
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