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TwoLegs Consulting | Change the Paradigm // Start with the Patient

Patient-Centered Drug Development and Access There is a tremendous opportunity for the healthcare industry to change the paradigm and put the PATIENT at the center of its development and commercialization strategy.  TwoLegs Consulting is the new agency doing just that.  New, experienced and well-connected! TwoLegs Consulting delivers patient insight and outcomes at all stages of…

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TwoLegs Consulting | Change the Paradigm // Start with the Patient | twolegs-consulting.com Reviews
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Patient-Centered Drug Development and Access There is a tremendous opportunity for the healthcare industry to change the paradigm and put the PATIENT at the center of its development and commercialization strategy.  TwoLegs Consulting is the new agency doing just that.  New, experienced and well-connected! TwoLegs Consulting delivers patient insight and outcomes at all stages of…
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TwoLegs Consulting | Change the Paradigm // Start with the Patient | twolegs-consulting.com Reviews

https://twolegs-consulting.com

Patient-Centered Drug Development and Access There is a tremendous opportunity for the healthcare industry to change the paradigm and put the PATIENT at the center of its development and commercialization strategy.  TwoLegs Consulting is the new agency doing just that.  New, experienced and well-connected! TwoLegs Consulting delivers patient insight and outcomes at all stages of…

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1

Clinical Outcome Assessments | TwoLegs Consulting

http://twolegs-consulting.com/clinical-outcomes-assessment

Change the Paradigm / Start with the Patient. Regulatory Endorsement / Qualification. Thought Leadership and Coaching. Externalization of Senior Leadership. Measure the right thing well. Design clinical outcome assessment strategies to evaluate benefit and demonstrate clinical value. Review and select clinical outcome assessments that will provide meaning beyond statistical significance. Prepare and defend regulatory evidence dossiers to gain approval and support labeling language (FDA and EMA).

2

Regulatory Endorsement / Qualification | TwoLegs Consulting

http://twolegs-consulting.com/regulatory-endorsement-qualification

Change the Paradigm / Start with the Patient. Regulatory Endorsement / Qualification. Thought Leadership and Coaching. Externalization of Senior Leadership. Regulatory Endorsement / Qualification. Take the reviewer perspective. Approach regulatory submissions thinking strategically from the perspective of the reviewer. Design convincing evidence dossiers to demonstrate that clinical outcome assessments have content validity in the context of use, satisfactory measurement properties, and are interpretable.

3

Recent Work | TwoLegs Consulting

http://twolegs-consulting.com/recent-work

Change the Paradigm / Start with the Patient. Regulatory Endorsement / Qualification. Thought Leadership and Coaching. Externalization of Senior Leadership. After more than 15 years of research and advice in the field of outcomes research, many deliverables and advice have been provided in different therapeutic areas, covering a variety of strategic issues. The most recent examples of work include:. Development of a new evidence dossier template for the qualification of Clinical Outcomes Assessments.

4

Patient-Centered Drug Development | TwoLegs Consulting

http://twolegs-consulting.com/patient-centered-drug-development

Change the Paradigm / Start with the Patient. Regulatory Endorsement / Qualification. Thought Leadership and Coaching. Externalization of Senior Leadership. Reconnect early development with patients. Define the intended context of use and the targeted patient population. Determine unmet needs and which outcomes matter to the targeted patient population. Draft treatment efficacy claims that convey meaning to patients. Identify the concepts of interest that provide direct evidence of treatment benefit.

5

Publications | TwoLegs Consulting

http://twolegs-consulting.com/publications

Change the Paradigm / Start with the Patient. Regulatory Endorsement / Qualification. Thought Leadership and Coaching. Externalization of Senior Leadership. WALTON M, POWERS J, HOBART J, PATRICK D, MARQUIS P. VAMVAKAS S, ISAAC M, PAPADOPOULOS E, SLAGE A, PIAULT E, BURKE L. Clinical Outcome Assessments for Clinical Therapy Trials: Conceptual Underpinnings. POWERS J, HOBART J, BURKE L, PATRICK D, MARQUIS P. LASCH K, MARQUIS P. DIBENEDETTI DB, GONDEK K, SAGNIER PP, KUBIN M, MARQUIS P. KEININGER D et al....

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Change the Paradigm / Start with the Patient. Regulatory Endorsement / Qualification. Thought Leadership and Coaching. Externalization of Senior Leadership. Patient-Centered Drug Development and Access. There is a tremendous opportunity for the healthcare industry to change the paradigm and put the. PATIENT at the center of its development and commercialization strategy. TwoLegs Consulting is the new agency doing just that. New, experienced and well-connected! Regulatory Endorsement / Qualification.

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