Oncology clinical pathways are reshaping treatment decisions. Learn how manufacturers can effectively engage pathway developers in our white paper. Download now to transform your market access strategy today! https://lnkd.in/eJ5ajU56 #oncologypathways #marketaccess #oncology
Genesis Research Group
Research Services
Hoboken, New Jersey 9,371 followers
Innovate differently
About us
Genesis Research Group empowers life science companies to innovate differently by fundamentally transforming the way they engage with research partners. Through the integration of robust stakeholder insights (RPR®), data-agnostic expertise, and a revolutionary engagement model, we deliver real-world evidence, HEOR, and market access solutions that enable our partners to anticipate and address the evolving needs of payers, regulators, and stakeholders. Email [email protected] to find out more.
- Website
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http://www.genesisrg.com
External link for Genesis Research Group
- Industry
- Research Services
- Company size
- 201-500 employees
- Headquarters
- Hoboken, New Jersey
- Type
- Privately Held
- Founded
- 2009
- Specialties
- Data Analytics, Modelling, Simulation & Risk Analytics, Meta Research, Epi-Safety, Litigation support involving Biopharmaceuticals, Medical Writing, Scientific Writing, Artificial Intelligence, Machine Learning, Natural Language Processing, HEOR, Health Economics, Outcomes Research, Epidemiology, Market Access, Pricing, Reimbursement, Systematic Literature Review, Pricing, Literature Review, Health Consultancy, Comparative Analysis, Network Meta Analysis, Cost Effectiveness, Cost Utility, Strategy, Indirect Comparison, Meta Analysis, Observational, Naturalistic, Pharmaceutical Consultancy, Pharma Careers, Drugs Access, Life Sciences, Biotechnology, and stakeholder validation
Locations
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Primary
111 River Street
Suite 1120
Hoboken, New Jersey 07030, U, US
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West One, Forth Banks
Newcastle upon Tyne, England NE1 3PA, GB
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Hydrabad, IN
Employees at Genesis Research Group
Updates
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We look forward to seeing everyone at the upcoming International Society for Pharmacoepidemiology Annual Meeting 2024 in Berlin! Our RWE, Epi, and Pharmacoepidemiology experts will be there ready to connect. Deb Casso, Marlene S., Alexandra Sosinsky, Andy S., Laura Elkayam, Diane Carpentier #ISPE2024 #Pharmacoepidemiology #RealWorldEvidence
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Genesis Research Group's RWE experts Alexandra Sosinsky, Craig S. Parzynski and Deb Casso shared their strategies and considerations to optimize external control arm study success in this recent Value in Health article. Connect with Alexandra and Deb at the upcoming ISPE conference to learn more about our regulatory RWE experience. #rwe #ecas #externalcontrolarms #realworldevidence https://lnkd.in/eHnawKbr
The Role of External Control Arms in Drug Development and Considerations for Success
ispor.org
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Last week's IRA announcement created more questions than answers. So, where do you go from here? Let our highly experienced team of experts help you get the clarity you need in as little as three weeks using our stakeholder engagement tool RPR. #marketaccess #medicare #innovatedifferently
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We’re excited to share that Genesis Research Group are lanyard sponsors at the upcoming International Society for Pharmacoepidemiology Annual Meeting 2024 in Berlin! Our RWE, Epi, and Pharmacoepidemiology experts will be there ready to connect. Deb Casso, Marlene Smurzynski, Alexandra Sosinsky, Andy S., Laura Elkayam, Diane Carpentier We look forward to seeing you there! #ISPE2024 #Pharmacoepidemiology #RealWorldEvidence
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Shaping the Future of Real-World Evidence: "By embracing innovation, maintaining data agnosticism, and fostering collaboration, we can accelerate healthcare product development and improve patient outcomes." - David W. Miller. Our CEO, David W. Miller, shares his vision in a new blog post on how recent FDA guidance, data agnosticism, and innovative approaches are transforming RWE research. Discover how we're driving outcomes research forward. Read the full article. #RealWorldEvidence #HealthcareInnovation #GenesisResearchGroup
In the rapidly evolving field of Real-World Evidence (RWE), we must recognize that it's our responsibility to not just keep pace with changes, but to actively shape the future of RWE research. I believe that by embracing innovation, maintaining data agnosticism, and fostering collaboration, we can accelerate healthcare product development and improve patient outcomes. #realworldevidence #innovatedifferently
Navigating the Future of Real-World Evidence: The Need for Innovation and Data Agnosticism
David W. Miller on LinkedIn
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In case you missed it our Executive Director and Head of Biostatistics & Analytics, Craig S. Parzynski, recently shared his expertise on the RWD/RWE Club podcast. He discussed key considerations in using Real World Data (RWD) for Real World Evidence (RWE) and clinical trials. Craig's participation highlights Genesis Research Group's commitment to advancing the field of biostatistics and analytics in healthcare research. Listen to the full episode on the RWD/RWE Club website. #Biostatistics #RealWorldData #HealthcareAnalytics
Last week we had a conversation with Craig Parzynski, Executive Director and Head of Biostatistics & Analytics at Genesis Research Group about major considerations in the use of RWD in RWE and for clinical trials. This was a conceptual conversation at the business leader level, with no expectations of biostatistical experience or expertise. If you missed it, you can now listen to the podcast episode on our website: https://lnkd.in/gbpGRjHY Craig S. Parzynski Matt Veatch Aaron Kamauu MD MS MPH Please check-out our website to join the club, get updates and see other podcast recordings: https://rwd-rwe.club #realworlddata #rwd #realworldevidence #rwe #datascience #clinicalresearch #drugdevelopment #healthcareanalytics #clinicaltrials #drugdevelopment #medicalinformatics #EHR #electronichealthrecords #EMR #electronicmedicalrecords #operationaldefinitions #computableoperationaldefinitions #codef #computablephenotypes #computablemeasures #measurelibrary #trialtokenization #triallinkage #augmentedtrials #datalinkage #digitialhealth #collaboration #biostats
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The 'Spotlight' and future outlook for ECA studies remains bright thanks to researchers and regulators carefully considering evidentiary standards and methodology recommendations. In the latest edition of ISPOR—The Professional Society for Health Economics and Outcomes Research's Value and Outcomes Spotlight, Genesis Research Group's RWE experts share insights into common biases in external control arm (ECA) studies and their strategies and considerations to optimize ECA success. Congratulations to Alexandra Sosinsky, Craig S. Parzynski, and Deb Casso on their recent publication. #ECA #outcomesresearch https://lnkd.in/eHnawKbr
The Role of External Control Arms in Drug Development and Considerations for Success
ispor.org
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The FDA has finalized its guidance on using electronic health records (EHR) and medical claims data to support regulatory decisions for drugs and biologics. The FDA remains data-source neutral, interested in the data that can best address the specific research question at hand. Similarly, Genesis Research Group, a data-agnostic company, continually surveys the RWD landscape, weighing benefits and challenges of various options. Our clients benefit from: - Comprehensive data landscape analyses - Time savings as we track evolving RWD options - High-level strategic view of RWE impact - Unbiased expertise in selecting optimal data sources Our established partnerships accelerate collaborations with data vendors and streamline agreements. Let's connect to discuss how our deep understanding of regulatory requirements and broad RWE expertise can support your regulatory and payer strategy with robust, fit-for-purpose RWE. #rwe #rwd #regulatory #biopharmaceuticals
Today, FDA issued the final guidance, "Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products": https://lnkd.in/geANjjW7 The guidance includes recommendations for sponsors and other interested parties proposing to use data from electronic health records (EHRs) or medical claims to help support a new use of an FDA-approved drug or biological product or to help support or satisfy post-approval study requirements.
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We look forward to this coming Monday as our Biostatistician team is making their way to the Joint Statistical Meetings (JSM) 2024 in Portland, Oregon. Join us at the Biopharmaceutical Section Contributed Poster Presentations on Monday, August 5, from 10:30 AM – 12:20 PM at the Oregon Convention Center (room CC-Hall CD). #RealWorldEvidence #CausalInference #Biostatistics