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Omega CRO

Omega CRO is listed as a mid sized business research supplier in the Scientist.com network, with 3 sites in 1 country and 1 service area.

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Search companies, drugs, suppliers and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.

Sites 3

Countries 1

Type of company: Mid sized business

Brand Communications

Patient-HCP Communication Aids Design and development of tools (visuals, guides, devices) that facilitate clear, accurate, and empathetic two-way dialogue between patients and their healthcare providers.

Clinical Consulting

Clinical Development Planning Complex document that entails the entire clinical research strategy of a drug, describing the clinical studies that will be carried out for a pharmaceutical entity.
Clinical Protocol Design & Development Creation of clinical protocol document which details how a clinical trial is designed, relating to to the methodology, hypothesis, and operation of clinical trial to ensure the safety of the patients is...
Clinical Trial Feasibility Request services related to Clinical Trial Design and feasibility.
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

Bioequivalence Studies Assess the expected biological equivalence of two proprietary preparations of a drug.
Case Report Monitoring & Auditing Ensure the adequate collection and traceability of clinical data in preparation for review by the FDA.
Central Institutional Review Board Services Ensure the safety and protection of human subjects participating in a study.
Clinical Research Services Determine the safety and effectiveness of medications and medical devices.
Clinical Trial Design Develop study-related protocols, case report forms (CRFs) and database tools for records management.
Clinical Trial Risk Management Plan that maintains treatment quality throughout lifecycle and improve decision making.

Show all 25 in Clinical Trials 19 more

eCOA - Electronic Clinical Outcomes Assessments Use smartphones, computers and tablets to allow patients to directly report health outcomes.
ePRO - Electronic Patient-reported Outcome Patient reported outcome collected by electronic methods.
Investigator Meeting Planning & Execution Investigator planning and meetings ensure that there is proper communication and reliability during a clinical trial. Allows for efficient work flow.
Investigator Recruitment Enlist clinical research experts to assist in investigator selection, recruitment monitoring and database evaluation.
IP Import/ Export Licensing Receive assistance with intellectual property import and export licensing.
IP Labeling Proper IP labeling guidelines are produced by the Food and Drug Association. Based on the compound or product in need of proper labelling there are guidelines that can be followed.
IP Packaging Proper packaging of pharmaceutical products and goods is crucial to ensure the validity and quality of the product being supplied. Proper investigational product packaging is aided by the use of quality...
IRT Services IVRS and Drug supply services allow research conducting clinical trials to receive real time subject updates, drug supply and shipment tracking, and randomization for the clinical trial. These...
Patient Recruitment Recruit and retain patients for clinical trials.
Phase 1-3 Studies Design phase 1-3 studies that seek to identify if a drug is safe, effective, and more efficient than other available treatments on the market.
Post-Marketing (Phase 4) Studies Conduct phase 4 studies for confirming unrecognized safety issues, investigating possible hazards or establishing the expected safety profile of a veterinary medicinal product under market conditions.
Prospective Explorative Studies Conduct a prospective exploratory study to assess the safety and efficacy of a test drug during clinical trials.
Recruiting Healthy Volunteers Recruit volunteers who have no known significant health problems, and is willing and consenting to participate in research to test a new drug, device, or intervention.
Recruiting Special Populations Recruitment of volunteers who are categorized as part of a special population, or a protected part of the population such as the elderly, women, and children.
Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
Site Monitoring Maintain oversight over participant's health during a clinical trial.
Site Selection Select clinical trial sites with clinicians who recruit, enroll, treat and evaluate trial patients.
Site/Patient Payments Allow for different suppliers to organize the proper patient and site payments for a clinical trial. Provides real-time payments, reduce workloads for site staff and minimize the amount of time participants spend...
Study/Site Feasibility Study Explore and test study practicality.

Show all 130 services 117 more

Creative

Case Studies Recruit research participants with a behavioral condition to receive either an investigational behavioral intervention or a behavioral intervention in clinical use.

Data Science/Bioinformatics

Biostatistical Design Use statistics to ensure appropriate pre-clinical and clinical study design.

DNA & RNA

DNA Synthesis Produce DNA fragments for microarrays, PCR, cloning and expression studies.
Gene/Oligo Synthesis Synthesize oligonucleotide or gene for microarrays, RT-PCR and PCR cloning.

General Marketing

Database Management Software Facilitate the collection, tracking and processing of biological facts, statistics and observations.

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.

Show all 12 in HEOR 6 more

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.
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.

Market Access

Emerging Market Opportunities Analyze risks and opportunities in new markets and ensure patients have timely and continued access to new treatments.
Environmental Analysis Research or strategy related to understanding the market (size, competition, reimbursement, challenges, etc.) and is a tool used to understand if a product can be launched in the market.
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...
Life Science Reports Life Science reports

Show all 16 in Market Access 10 more

Market Access - HTA Landscape Assessment Conduct a HTA landscape assessment to evaluate the direct and indirect impact of health technology on a specific region.
Market Access Materials Find general strategies and methods used to market a pharmaceutical product or device.
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.
Pharmaceutical Reports Pharmaceutical Reports
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.
Study Start Up Consulting Request for RWE/HEOR/Market Access Study Start Up Consulting
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
Animated Content Development of diverse visual, interactive digital assets like infographics, data visualizations, and short animations to explain complex medical and scientific concepts simply.
Case Reviews Review medical cases from Clinical Trials.
Communication Plan Communications plan enables organizations and corporations to effectively deliver information to appropriate stakeholders and customers.
Congress Listening/Insights Report Systematic collection, analysis, and summary of key discussions, scientific trends, competitor movements, and data presented at major medical congresses.
Consensus reports Develop and submit a report that is a comprehensive examination by an expert panel of a scientific or medical issue.

Show all 23 in Medical Communications 17 more

Data Visualization Visualize data collected from clinical trials and/or clinical research.
Gap Analysis Compare the actual performance of an organization or corporation with potential or desired performance, as ways to effectively analyze resource management or allocation.
KEE Identification, Mapping & Engagement Planning Systematic process to identify, categorize, and strategically plan outreach to Key External Experts (KEEs) based on their influence, specialization, and research activity.
KOL Engagement & Management Building and maintaining compliant, value-driven relationships with Key Opinion Leaders (KOLs) to collaborate on scientific exchange and clinical education initiatives.
Market & Competitor Analyses Evaluating the current therapeutic landscape, identifying unmet needs, and assessing the scientific positioning and data of competitor products.
Medical Affairs Dossiers Develop medical affairs dossiers such as Global Value Dossiers or AMCP Dossiers.
Medical letters, Emails & Customized Responses Drafting accurate, balanced, and compliant answers to unsolicited scientific and medical inquiries from healthcare professionals or consumers.
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.
Patient Narratives Compliant collection and use of individual patient stories to illustrate the impact of a disease or treatment, often for training or empathy-building purposes.
Poster Design and Development Design and Develop Posters for Poster Symposiums and conferences to effectively convey science information.
Protocol and Study Reports Write protocol and study reports, specifically relating to the drafting, writing, and editing of Clinical Safety Reports.
Publications Plan Development & Management Strategic planning and oversight of all research dissemination activities, including outlining target journals, timelines, authors, and compliance for clinical data publications.
Regulatory Submissions and Compliance Draft, format, and submit documents to Pharmaceutical approval agencies according to documentation and guidelines. This includes documents such as NDAs, INDs, SUSARs, AE reporting, RMPs, and PSURS.
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.
Strategic Medical Communication Development & Planning High-level planning to define the core scientific messages and the tactical strategy needed to effectively convey clinical data to key stakeholders over time.

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.

Pharmacovigilance

Adverse Event (AE) and Serious Adverse Event (SAE) Reporting Report unfavourable and unintended events (e.g.: abnormal laboratory results, symptoms or disease associated with treatments) to regulatory bodies via the FDA's Adverse Event Reporting System (FAERS) or other...
Local Pharmacovigilance Support in International Markets Connect with Pharmacovigilance professionals to uphold the National pharmacovigilance guidelines and regulations.
Pharmacovigilance Training and Education Training and education related to pharmacovigilance guidelines and adherence to EMA, FDA, and other regulatory bodies' documentation
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...

Real World Evidence & Data

Claims Data & Database Analysis Analysis of care cost and quality.
Clinical Data Registry A study or collection of data regarding the health of patients and the care they receive over different time periods.
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.
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).

Show all 24 in Real World Evidence & Data 18 more

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.
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.
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 - 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.
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

Patient Risk Management Identify, contain, and manage risks related to patient safety.
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...
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.

Show all 7 in Regulatory Affairs 1 more

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...

Other services

Observational Research Gain valuable insights into the association between a drug treatment and its outcomes such as long-term effectiveness and safety.
Trial Awareness Create awareness about a clinical trial.

Service areas:

Clinical

Turkiye Ankara 3 sites

Omega CRO offers clinical research services such as clinical trial management, site management, data management, and statistics services.

Website: www.omega-cro.com.tr

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