CASE STUDY

PRA on Time in Global Data Management ProjectExtra Effort, Flexibility Keys to Timely Closeout

PRA on Time in Global Data Management ProjectExtra Effort, Flexibility Keys to Timely Closeout

STUDY SPECIFICS

Study Duration 8 Years

Laboratory Records2M

Active Trial Sites700+

Case Report Form Pages2M+

Randomized Patients 9,500+

Adverse Events 110,400+

Data Clarification Forms207,000+

Serious Adverse Events6,700+

Countries 40

Coded Terms381,270+

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.

Achieving Success

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.© PRAHS 2019. All rights reserved.

Database Lock

0.07% Final QC Error Rate*

Flexible Resourcing Model

• 15 PRA data managers in the core team

• 30 additional data managers trained for the closeout period

• 24-hour workflow with global teams in 3 locations

• 200+ PRA staff members participated in this project in the final 3 months

* Compared to acceptable standard of 0.10%

Data Closeout in 8 Weeks

• 2 weeks final CRF collection

• 4 weeks final data entry and validation

• 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

Total CRF Pages & DCFs Processed During the Final 6 Months

Data Flow - Total CRF Pages/DCFs Processed Per Year

0

20,000

40,000

60,000

80,000

100,000

Jul Aug Sep Oct Nov Dec

CRF Pages Processed DCFs Processed

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 80

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

CRF Pages Processed DCFs Processed

JJUL2015