TMO: The Trial Management Organization—A New System for Reducing the Time for Clinical Trials: The trial management organization—A new system for reducing the time for clinical trials

Karl E. Peace

doi:10.1177/009286159002400139

TMO: The Trial Management Organization—A New System for Reducing the Time for Clinical Trials: The trial management organization—A new system for reducing the time for clinical trials

Karl E. Peace

Biostatistics, Epidemiology & Environmental Health Sciences

Biopharmaceutical Research Consultants, Inc.

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Commercial clinical drug development requires formulating the clinical development plan, executing the plan, compiling the regulatory dossier, and regulatory review and approval of the dossier. Streamlining the development plan with fewer but larger studies, executing the plan using a trial management organization (TMO) approach, taking a proactive, standardized approach to compiling the regulatory dossier, and requiring total quality may shorten the total time required to approval.

Original language	American English
Pages (from-to)	257-264
Number of pages	8
Journal	Therapeutic Innovation and Regulatory Science
Volume	24
Issue number	1
DOIs	https://doi.org/10.1177/009286159002400139
State	Published - Jan 1 1990

Scopus Subject Areas

Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)

Disciplines

Public Health
Biostatistics

Keywords

Clinical
Proactive
Quality
Standardization
TMO

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1177/009286159002400139License: Unspecified

Cite this

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KW - Quality

KW - Standardization

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TMO: The Trial Management Organization—A New System for Reducing the Time for Clinical Trials: The trial management organization—A new system for reducing the time for clinical trials

Abstract

Scopus Subject Areas

Disciplines

Keywords

UN SDGs

Access to Document

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