Berkeley Research Group

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Clinical Trials

Prospective Explorative Studies Conduct a prospective exploratory study to assess the safety and efficacy of a test drug during clinical trials.
Statistical Analysis Planning Technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables...
Study/Site Feasibility Study Explore and test study practicality.
Synthetic Control Arm Creation Using RWD Using patient data from sources like electronic health records or claims databases to construct a comparator group for clinical trials, instead of enrolling a separate group of control patients.

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 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.

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Decision Analytic Modeling Assess effects, costs and economic outcomes of treatment. These include cost-effectiveness models and budget impact models.
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.

Market Access

Academy of Managed Care Pharmacy (AMCP) Dossier 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...
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.
Population Health Analytics Aggregation of patient data across multiple health information technology resources, the analysis of that data into a single, actionable patient record, and the actions through which care providers can improve both...
Pricing Strategy Develop value story tailored to a payer audience that will determine the appropriate price for treatment.

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Study Start Up Consulting Request for RWE/HEOR/Market Access Study Start Up Consulting
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...

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Medical Communications

Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.

Medical/Commercial

Health & Pharmacoeconomics Identify, measure and compare the cost-benefit ratio of products and services.

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/HEOR/Market Access Disease/Clinical Outcomes Study the course of disease and the possible outcome of disease, including expected frequency.
RWE/HEOR/Market Access Hybrid Study 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.
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 - 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.
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.
Cohort Study Investigating the causes of disease to establish links between risk factors and health outcomes.
Data Merging Tools for combining various data sets into a single data set. Includes data consolidation.

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Exploratory Study Explore study design, outcomes, data-collection method, and selection of population for a topic that needs more research information.
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.
Payer Outcomes-Based Contract Trial Study or analysis of data (claims, electronic HR/MR) to assess reimbursement or price to actual health outcomes.
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
Retrospective Exploratory Studies Retrospective exploratory studies
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.
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)
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.
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...

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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...

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