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DRUG DEVELOPMENT PROCESS: Outsourced Study Sample Timeline
 

STUDY PLANNING CHECKLIST AND SAMPLE TIMELINE FOR PRE- AND POST-STUDY ACTIVITIES

Activity

T-50

T-40

T-30

T-20

T-10

In-Life Phase

T+10

T+20

T+30

T+40

T+50

T+60

T+70

a) Initial planning T-50                          
b) Confidentiality agreement                          
c) Request for draft quote T-50                          
d) Approval of draft quote T-45                          
e) Initial study plan T-30                          
  1) Analysis of dose solutions (method and schedule)
                         
  2) Animal husbandry
                         
  3) Health/safety
                         
  4) Test and control article handling and storage
                         
  5) Supplies
                         
  6) Dosing: route of administration, regimen, duration
                         
  7) Dose preparation
                         
  8) Clinical operations
                         
  9) Necropsy/gross pathology
                         
  10) Clinical chemistry parameters
                         
  11) Histopathology parameters
                         
  12) Analysis of data (statistics)
                         
f) Draft study protocol  T-28                          
  1) Sponsor review
  2) IACUC review
                         
  3) QA review
                         
g) Set pre-study meeting date (CRO staff) T-28                          
h) Pre-study Sponsor—CRO meeting (preferably in person, or by video  or teleconference)  T-14                          
  1) Appropriate staff
                         
    a) Sponsor company:  technical contact, admin contact, other
                         
    b) CRO: technical management, study director, QA, admin
                         
  2) Review and clarify: protocol, study background, deadlines
                         
i) Protocol approval T-10                          
j) Sponsor transfers test article to CRO T-3                          
k) Sponsor and QA review draft report T+29 to T+50                          
l) Sponsor receives final report T+60                          
m) Team review/evaluation with CRO T+70                          


Download printable version of our booklet Preclinical Toxicology - Points to Consider in Program Design (PDF).