Real-World Evidence

The focus on real-world evidence (RWE) affects every stage of your drug or device development lifecycle. You need evidence to prove value to all stakeholders, including regulators, payers, providers, and patients. This means RWE is playing an increasingly critical role in supporting every aspect of successful evidence-generation programs, including clinical, market access, outcomes research, patient preference, economic evaluation, reimbursement, and safety activities.

Our experts have been collecting and analyzing prospective and retrospective real-world data for decades, and they stay abreast of evolving methods and guidelines to provide you with knowledgeable support and advice.

Evidence You Need, When You Need It

You need to know where your research requirements fall under the broad umbrella of RWE. We help by designing and conducting the right study and staying with you throughout your product's lifecycle. We recommend and have a track record of implementing proactive plans for RWE to support strategic product development.

We start with the research questions you need to have answered and utilize appropriate methodologies and data sources, to inform a strategic approach to your RWE activities. Our expert study designs and analyses ensure you can trust the results and confidently act on them.

We recognize that RWE needs differ by therapeutic area, type of product, and patient population. Leverage the wide-ranging expertise we’ve acquired from working on hundreds of different drugs in nearly every therapeutic area to help commercialize your products.

Our Approach

Adding Value Through Collaboration

With our multi-disciplinary team environment, you'll benefit from the integrated services provided by our health economics, market access, observational studies, biostatistics, and pharmacoepidemiology teams. From HEOR strategic roadmaps and payer and pricing research to HTA submissions and value communication materials to studies to meet regulatory requirements, we bring together the best teams from across the organization to meet your objectives.

 

Recent Publications

Girman CJ, Ritchey ME, Zhou W, Dreyer NA. Considerations in characterizing real‐world data relevance and quality for regulatory purposes: a commentary. Pharmacoepidemiol Drug Saf. 2018 Dec 5. doi: 10.1002/pds.4697.

Magrey M, Bozyczko M, Wolin DMordin MMcLeod LDavenport EChirila C, Park Y. A pilot study to assess the feasibility of a web-based survey to examine patient-reported symptoms and satisfaction in patients with ankylosing spondylitis receiving secukinumab. Drugs Real World Outcomes. 2019 May 3;6(2):83-91. doi: 10.1007/S40801-019-0154-4.

Meyers JLCandrilli SD, Rausch DA, Yan S, Patterson BJ, Levin MJ. Costs of herpes zoster complications in older adults: a cohort study of US claims database. Vaccine. 2019 Feb 21;37(9):1235-44.

Horn L, Bauml J, Forde PM, Davis KL, Myall NJ, Sasane M, Dalal A, Culver K, Wozniak AJ, Baik CS, Mutebi A, Zhang P, Wakelee HA, Johnson BE. Real-world treatment patterns and survival of patients with BRAF V600-mutated metastatic non-small cell lung cancer. Lung Cancer. 2019 Feb;128(2019):74-90.

Poulos C, Standaert B, Sloesen B, Stryjewska I, Janitsary A, Hauber BPreferences for vaccines against children's diarrheal illness among mothers in Poland and Hungary. Vaccine. 2018 Sep 25;36(40):6022-9.

Cainzos-Achirica M, Rebordosa C, Vela E, Cleries M, Matsushita K, Plana ERivero-Ferrer E, Enjuanes C, Jimenez-Marrero S, Garcia-Rodriguez LA, Comin-Colet J, Perez-Gutthann SChallenges of evaluating chronic heart failure and acute heart failure events in research studies using large health care databases. Am Heart J. 2018 Aug;202:76-83.

Wamble DE, Ciarametaro M, Dubois R. The effect of medical technology innovations on patient outcomes, 1990-2015: results of a physician survey. J Manag Care Spec Pharm. 2019 Jan;25(1):66-71.

Mordin MBuck PMCastro CFernandez MMHollis KARitchey MEWhat does "Real World" evidence mean? A review of 2017 literature. Poster presented at the ISPOR 23rd Annual International Meeting; May 22, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl 1):S108.

Price MARichardson DValue of conducting feasibility studies in observational research. Presented at the 9th Annual SCOPE Summit Conference; February 13, 2018. Orlando, FL.