Assessing Outsourcing Oversight Practices and Performance.
contract research organizations
outsourcing
oversight
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
01
10
2018
accepted:
13
11
2018
entrez:
3
2
2020
pubmed:
3
2
2020
medline:
19
5
2021
Statut:
ppublish
Résumé
The Tufts Center for the Study of Drug Development conducted a study updating benchmarks on outsourcing model adoption and assessing oversight practices and experience. An online survey examining organizational use of clinical development outsourcing was distributed between February and April 2018. Responses from a total of 88 individuals were included in the final analysis. More than half of individuals responding reported using 3 or more models simultaneously, mixing and matching approaches to meet individual project needs. Outsourcing practices among small, medium, and large sponsor companies remain inconsistent and deliver mixed levels of satisfaction and performance. Full-service models are the most commonly used. Biopharmaceutical companies report that the primary purpose of their oversight mechanisms is to minimize risks and regulatory missteps. Oversight mechanisms are generally supported by middle management personnel focusing on more reactive and tactical issues. Executive-level involvement in outsourcing oversight is minimal and highly variable. Several opportunities to improve oversight practices were identified in the study, including increasing executive-level involvement and leveraging technologies to monitor performance, enhance communication, and expand collaboration capabilities.
Sections du résumé
BACKGROUND
The Tufts Center for the Study of Drug Development conducted a study updating benchmarks on outsourcing model adoption and assessing oversight practices and experience.
METHODS
An online survey examining organizational use of clinical development outsourcing was distributed between February and April 2018. Responses from a total of 88 individuals were included in the final analysis.
RESULTS
More than half of individuals responding reported using 3 or more models simultaneously, mixing and matching approaches to meet individual project needs. Outsourcing practices among small, medium, and large sponsor companies remain inconsistent and deliver mixed levels of satisfaction and performance. Full-service models are the most commonly used. Biopharmaceutical companies report that the primary purpose of their oversight mechanisms is to minimize risks and regulatory missteps. Oversight mechanisms are generally supported by middle management personnel focusing on more reactive and tactical issues. Executive-level involvement in outsourcing oversight is minimal and highly variable.
CONCLUSION
Several opportunities to improve oversight practices were identified in the study, including increasing executive-level involvement and leveraging technologies to monitor performance, enhance communication, and expand collaboration capabilities.
Identifiants
pubmed: 32008252
doi: 10.1007/s43441-019-00040-2
pii: 10.1007/s43441-019-00040-2
doi:
Substances chimiques
Biological Products
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM