CASE STUDY
P R A H E A LT H S C I E N C E S
P RA O N TIME IN GLO BAL
DATA M A NAGE ME NT P R OJE CT
Extra Effort, Flexibility Keys to Timely Closeout
P R A H E A LT H S C I E N C E S C A S E S T U D Y
P R A O N T I M E I N G LO B AL DATA MANAGE ME NT P R OJE CT
Extra Effort, Flexibility Keys to Timely Closeout
S T UDY S PEC IF IC S
STUDY DURAT ION
8
ACT IVE T RIA L S I T E S
R A ND O MI Z E D P A T I E NT S
700+
YEARS
LA BO RAT O RY R E CO R D S
C O UN TRIE S
40
ADVE RSE E VENT S
110,400+
D A T A C LA R IF ICATION
FO R MS
9,500+ 207,000+
CA SE R E P O RT
F O R M PA G E S
2M+
CRF
2M+
CRF
S ERIOUS AD VE R S E
EVENT S
6,700+
C O DE D TE RMS
“”
381,270+
AC HI E VI N G S U CCE S S
PRA Health Sciences performed data management activities for this project while the client was responsible for all other
services, including site monitoring. When the client reduced the timelines for database lock by approximately 9 months,
PRA immediately created a detailed closure plan, listing all tasks and activities that required completion within the given
timelines. This plan was reviewed and approved by all parties involved. To successfully complete the closeout period, PRA
calculated data flows and trained additional staff members.
Three of PRA’s data centers were involved in the closeout, and the regional team leads were responsible for managing the
workload assigned to their region. The PRA project team defined workflows to ensure all tasks were performed and no task
was repeated in different regions. We regularly amended the closure plan and data flow to reflect the closeout periods, and
we used our internal reports to monitor the progress. PRA’s dedicated team members worked extra hours and weekends, as
needed. In addition, support from all other parties, particularly the client’s project team, CRAs, and other external vendors,
ensured timely and smooth data processing by PRA.
THE FUTURE OF CLINICAL DEVELOPMENT.
P R A H E A LT H S C I E N C E S C A S E S T U D Y
D at a C loseo ut i n 8 We e ks
400,000
• 2 weeks final CRF collection
350,000
• 4 weeks final data entry and validation
300,000
• 2 weeks stats review and issue resolution
• 156,620 CRF pages received, reviewed,
entered, and cleaned
• 28,985 data clarification forms (DCFs)
received and processed
• 3.5 million critical variables underwent
final quality control (QC) check
250,000
200,000
150,000
100,000
50,000
0
Year 1
Year 2
Year 3
Year 4
CRF Pages Processed
Year 5
Year 6
Year 7
Year 8
DCFs Processed
Figure 1: Data Flow - Total CRF Pages/DCFs Processed Per Year
Da t a ba se L o c k
100,000
0 . 0 7% F i n a l QC Error Ra te*
*compared to acceptable standard of 0.10%
80,000
F L E X I B L E R E S O U RCI N G M O DE L
60,000
• 15 PRA data managers in the core team
40,000
• 30 additional data managers trained for the
closeout period
20,000
• 24-hour workflow with global teams in 3
locations
• 200+ PRA staff members participated in this
project in the final 3 months
0
Jul
Aug
CRF Pages Processed
Sep
Oct
Nov
Dec
DCFs Processed
Figure 2: Total CRF Pages & DCFs Processed During the Final 6 Months
PRA Health Sciences conducts comprehensive Phase I-IV biopharmaceutical drug development.
To learn more about our solutions, please visit us at prahs.com
or email us at prahealthsciences@prahs.com.
THE FUTURE OF CLINICAL DEVELOPMENT.
© PRAHS 2015. All rights reserved. 7.15