REAL-WORLD EVIDENCE:
DATA COLLECTION

What We DO

  • Publications

    Publication

    The Impact of β-Amyloid Positron Emission Tomography on the Diagnostic and Treatment Decisions of Dementia Experts. Neurodegener Dis Manag. 2017 Apr;7(2):107-117. doi: 10.2217/nmt-2016-0059. Epub 2017 Apr 26. ABSTRACT

    Publication

    Administration and Burden of Subcutaneous Immunotherapy for Allergic Rhinitis in U.S. and Canadian Clinical Practice. J Manag Care Spec Pharm. 2015 Nov;21(11):982-990. ABSTRACT

    Publication

    Opioid-Induced Constipation Among Patients with Chronic Noncancer Pain in the United States, Canada, Germany, and the United Kingdom: Laxative Use, Response, and Symptom Burden Over Time. Pain Med. 2015 Aug;16(8):1551-65. Epub 2015 Mar 20. ABSTRACT
    See More
  • Webinars

    Webinar

    Hot Topics for Risk Evaluation and Mitigation Strategy (REMS) Programs

    Presenters: Kristin Veley, PharmD, MPH, Research Scientist and Director, REMS and Pregnancy Registries, Evidera; Sheila Weiss, PhD, FISPE, Senior Research Leader, Drug Safety, Evidera; Robin Kinard, Senior Director, Risk Management Programs, PPD

    Additional Info
    Contact us for slides

    Webinar

    Social Media: A Rich Data Source or a Can of Worms?

    Presenters: Andrew Paul Cox, PhD, Research Scientist, Real-World Evidence, Evidera

    Additional Info
    Contact us for slides

    Webinar

    Pregnancy Registries and Lactation Studies: Best Practices to Support Product Labeling

    Presenters: Deborah Covington, DrPH, Executive Director, Real-World Evidence, Evidera

    Additional Info
    Contact us for slides
    See More
  • White Papers

    Whitepaper

    Clinical Vocabularies for Global RWE Analysis

    Authors: Don O'Hara, MS, Senior Research Associate, Real-World Evidence; Vernon F. Schabert, PhD, Senior Research Scientist, Real-World Evidence, Evidera

    Year: 2017

    View

    Whitepaper

    Real-World Data Strategy: A Roadmap for Success

    Authors: Dimitra Lambrelli, PhD Research Scientist, Real-World Evidence, Evidera; Krista A. Payne, MEd Vice President of Late Phase Studies and Senior Research Scientist Real-World Evidence, Evidera

    Year: 2016

    View

    Whitepaper

    Evaluating the Optimal Approach to Address the Research Question

    Authors: Teresa K. Wilcox, PhD, RPh Senior Research Leader, Real-World Evidence, Evidera

    Year: 2016

    View
    See More
  • Presentations

    Oral Presentation

    Real World Data Strategy and Programs of Research: A Roadmap for Late Phase Success

    Next Level’s Medical Affairs Leaders Forum Europe (Spring):

    Berlin, Germany
    22-Feb-2016

    Authors/Presenters: Payne K, Lambrelli D

    Year: 2016

    View

    Oral Presentation

    Evaluating Critical Methodological Issues to Optimally Address the Research Question: What Are The Trade-Offs among Study Designs

    Medical Affairs Leaders Forum Europe – 2015:

    London, UK
    21-Oct-2015

    Authors/Presenters: Wilcox TK

    Year: 2015

    Poster

    Evaluation of EU Post-Authorization Safety Studies Using EU-RMP / European Public Assessment Reports: Analysis, Trends and Implications

    ICPE 2015:

    Boston, MA, USA
    22-Aug-2015

    Authors/Presenters: Neasham D, Baradaran S, Chalkiadaki C, Sadasivan R, Nordstrom B, Reynolds M

    Year: 2015

    See More
  • Fact Sheets

    Fact Sheet

    Real-World Evidence: Data Collection
    Download

    Fact Sheet

    Risk Evaluation and Mitigation Strategy (REMS) Programs
    Download

Observational data are often required to meet complex mandates by regulators and payers to demonstrate real-world product value, safety and effectiveness. In the absence of suitable sources of secondary data (e.g., literature, healthcare databases, electronic medical records), it is necessary to engage in primary data collection to generate this evidence.

Our real-world data collection team designs and executes studies that result in tailored, fit-for-purpose data to demonstrate real-world value of biopharma products and medical devices. In many cases, these data may be used to populate and validate economic models, or aid in the development and implementation of PRO instruments. We leverage our payer network and the insight it generates to design effective prospective studies.

Offerings

Patient or Physician Surveys

Evaluate outcomes of interest with direct to participant surveys, typically conducted via electronic data collection with no need for study sites.

Hybrid Database and Direct-to-Patient Studies

Build upon the available data with a cross-sectional or longitudinal database analysis of Rx and/or medical claims plus patient and/or site reported data.

Time and Motion Studies

Understand efficiency/time savings with a prospective time and motion study.

Medical Chart Review Studies

Evaluate burden-of-illness, patterns and/or costs of care, or patterns of drug utilization and (in)appropriate use via data abstraction from medical charts.

Prospective Studies Including Registries and Post-authorization Safety Studies (PASS)

Gather real-world clinical, health economic, outcomes research, or safety related endpoints to supplement or complement data from other studies.

Risk Evaluation and Mitigation Strategy (REMS) Programs

Ensure that the benefits of your product outweigh the risks utilizing our dedicated risk management team of regulatory, safety, and epidemiology experts. Read the fact sheet.

Real-World Evidence: Data Collection Experts

What We DO

  • Publications

    Publication

    The Impact of β-Amyloid Positron Emission Tomography on the Diagnostic and Treatment Decisions of Dementia Experts. Neurodegener Dis Manag. 2017 Apr;7(2):107-117. doi: 10.2217/nmt-2016-0059. Epub 2017 Apr 26. ABSTRACT

    Publication

    Administration and Burden of Subcutaneous Immunotherapy for Allergic Rhinitis in U.S. and Canadian Clinical Practice. J Manag Care Spec Pharm. 2015 Nov;21(11):982-990. ABSTRACT

    Publication

    Opioid-Induced Constipation Among Patients with Chronic Noncancer Pain in the United States, Canada, Germany, and the United Kingdom: Laxative Use, Response, and Symptom Burden Over Time. Pain Med. 2015 Aug;16(8):1551-65. Epub 2015 Mar 20. ABSTRACT
    See More
  • Webinars

    Webinar

    Hot Topics for Risk Evaluation and Mitigation Strategy (REMS) Programs

    Presenters: Kristin Veley, PharmD, MPH, Research Scientist and Director, REMS and Pregnancy Registries, Evidera; Sheila Weiss, PhD, FISPE, Senior Research Leader, Drug Safety, Evidera; Robin Kinard, Senior Director, Risk Management Programs, PPD

    Additional Info
    Contact us for slides

    Webinar

    Social Media: A Rich Data Source or a Can of Worms?

    Presenters: Andrew Paul Cox, PhD, Research Scientist, Real-World Evidence, Evidera

    Additional Info
    Contact us for slides

    Webinar

    Pregnancy Registries and Lactation Studies: Best Practices to Support Product Labeling

    Presenters: Deborah Covington, DrPH, Executive Director, Real-World Evidence, Evidera

    Additional Info
    Contact us for slides
    See More
  • White Papers

    Whitepaper

    Clinical Vocabularies for Global RWE Analysis

    Authors: Don O'Hara, MS, Senior Research Associate, Real-World Evidence; Vernon F. Schabert, PhD, Senior Research Scientist, Real-World Evidence, Evidera

    Year: 2017

    View

    Whitepaper

    Real-World Data Strategy: A Roadmap for Success

    Authors: Dimitra Lambrelli, PhD Research Scientist, Real-World Evidence, Evidera; Krista A. Payne, MEd Vice President of Late Phase Studies and Senior Research Scientist Real-World Evidence, Evidera

    Year: 2016

    View

    Whitepaper

    Evaluating the Optimal Approach to Address the Research Question

    Authors: Teresa K. Wilcox, PhD, RPh Senior Research Leader, Real-World Evidence, Evidera

    Year: 2016

    View
    See More
  • Presentations

    Oral Presentation

    Real World Data Strategy and Programs of Research: A Roadmap for Late Phase Success

    Next Level’s Medical Affairs Leaders Forum Europe (Spring):

    Berlin, Germany
    22-Feb-2016

    Authors/Presenters: Payne K, Lambrelli D

    Year: 2016

    View

    Oral Presentation

    Evaluating Critical Methodological Issues to Optimally Address the Research Question: What Are The Trade-Offs among Study Designs

    Medical Affairs Leaders Forum Europe – 2015:

    London, UK
    21-Oct-2015

    Authors/Presenters: Wilcox TK

    Year: 2015

    Poster

    Evaluation of EU Post-Authorization Safety Studies Using EU-RMP / European Public Assessment Reports: Analysis, Trends and Implications

    ICPE 2015:

    Boston, MA, USA
    22-Aug-2015

    Authors/Presenters: Neasham D, Baradaran S, Chalkiadaki C, Sadasivan R, Nordstrom B, Reynolds M

    Year: 2015

    See More
  • Fact Sheets

    Fact Sheet

    Real-World Evidence: Data Collection
    Download

    Fact Sheet

    Risk Evaluation and Mitigation Strategy (REMS) Programs
    Download
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