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

Keywords

Clinical
Proactive
Quality
Standardization
TMO

DC Disciplines

Public Health
Biostatistics

UN SDGs

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

Access to Document

10.1177/009286159002400139License: Unspecified

Cite this

@article{6cd9cf582d144593a7ba25578cf5318e,

title = "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 = " 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.",

keywords = "Clinical, Proactive, Quality, Standardization, TMO",

author = "Peace, {Karl E.}",

note = "Subscription and open access journals from SAGE Publishing, the world's leading independent academic publisher.",

year = "1990",

month = jan,

day = "1",

doi = "10.1177/009286159002400139",

language = "American English",

volume = "24",

pages = "257--264",

journal = "Therapeutic Innovation and Regulatory Science",

issn = "2168-4790",

publisher = "SAGE Publications Inc.",

number = "1",

}

TY - JOUR

T1 - TMO: The Trial Management Organization—A New System for Reducing the Time for Clinical Trials

T2 - The trial management organization—A new system for reducing the time for clinical trials

AU - Peace, Karl E.

N1 - Subscription and open access journals from SAGE Publishing, the world's leading independent academic publisher.

PY - 1990/1/1

Y1 - 1990/1/1

N2 - 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.

AB - 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.

KW - Clinical

KW - Proactive

KW - Quality

KW - Standardization

KW - TMO

UR - https://doi.org/10.1177/009286159002400139

UR - http://www.scopus.com/inward/record.url?scp=84973784283&partnerID=8YFLogxK

U2 - 10.1177/009286159002400139

DO - 10.1177/009286159002400139

M3 - Article

AN - SCOPUS:0024990849

SN - 2168-4790

VL - 24

SP - 257

EP - 264

JO - Therapeutic Innovation and Regulatory Science

JF - Therapeutic Innovation and Regulatory Science

IS - 1

ER -

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

Keywords

DC Disciplines

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this