Initial contact
Sponsor contacts YalePharma
YalePharma
receives proposal request
If a new Client/Sponsor
Confidentiality
Disclosure Agreements and Standard Master Agreements are
issued
If current Client/Sponsor
Contracts
are in place, prices generated in 72 hours
Proposal Review/Approval
Sponsor
reviews and accepts proposal price and proposal authorization
form is submitted for approval
Study designs are approved in final protocol format
and timeline are created
YalePharma assigns study Director and Unique study
number Upon receipt of signature for authorized
study
Study is scheduled
YalePharma
Allocates resources to perform study
Prior to study initiation
All protocols
are reviewed and approved by Institutional animal care and
use committee (IACUC)
Pre-Initiation meeting
Study
Directors hold pre-initiation meeting with study team and
encourage participation from sponsor
Test article is received and method validations
are completed before dose administration
Studies conducted
In accordance
with protocol regulations and SOPs-with documented study
Director supervision
QA reviews
Quality
assurance conducts QA reviews during any study according
to SOP 7-9-7. Selection and scheduling of critical phase
inspections
Report Results
Results
are generated and submitted to Sponsor upon completion of
in-life and post-life phases of studies
