How to keep the project on budget in the clinical trial study

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How to keep the project on budget in the clinical trial study

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www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd.

Disclaimer

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Any views or opinions presented in this presentation are solely those of the author and do not necessarily represent those of the company.


Agenda

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• Introduction of budgeting in Biometric department• Budget Items in clinical trial• Budget Template• Reasons of going over budget• How to save a budget• Review on the budget management after study

completion• Conclusion• Questions & Answers


Introduction of budget

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The project budget is the budget that is required to complete the project and it is based on• the number of deliverables required• the duration of the project• the accurate assessments of the resources However, a budget is meant to be an estimate, so it could change during the course of the project. The precision of estimation at the early stage becomes very important. In order to do the more accurate estimate, the budget items should be identified in the project.


Budget items in clinical study (1)

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Usual budget items in biometric department• Creation of SAP and Mock Up tables• The number of SDTM and ADaM• The number of Tables, Listings and Graphs• The frequency of deliverables



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Additional budget items in Biometric department• The number of project meeting• The number of data transfer (external and

internal)• Data reconciliation (e.g. LAB and IVRS)• Coding(e.g. WhoDrug and MedDRA)• Programming support to other department

such as data management and marketing• Ad hoc reports



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Additional budget items in Biometric department• Controlled Terminology• CDISC compliance checks (e.g.Opencdisc

checks on SDTM and ADaM)• The creation of Define document ( xml and pdf)• A complex analysis such as lab toxicity in

oncology and some efficacy analyses.• Project management


Example of Budget Template

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Number Task Hours for each task

Total Hours (hr)

Programmer’s Rate ($/hr)

Total Cost ($)

30 SDTM 10 300 $100 $30,00020 ADaM 10 200 $100 $20,000

100 TFL 10 1,000 $100 $100,000Total 1,500 $150,000

According to Budget Template, the budget for programming on 30 SDTM, 20 ADaM and 100 TFL with rate of $100/hr is $150,000.

Assumption : the same level of programmers and same hours for each task.


Reasons of going over the budget

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1. Incorrect budget in the contract2. Improper resources3. Poor Execution4. Incorrect deliverables5. Miscommunication


1 - Incorrect budget in the contract

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The number of budget items in the contract is less than the number of actual items delivered to clients.• 20 ADaM in the contract vs 30 ADaM in the

actual deliverables.• 100 TFL in the contact vs 120 TFL in the actual

deliverables


2 - Improper Resourcing (1)

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• Level – Junior-level programmers are assigned to senior-level tasks.

• Experience – Incorrect therapeutic assignment (ex,

Oncology, PK/PD, and so on) – Non-SDTM expert to SDTM projects / non-

ADaM expert to ADaM projects• No proper training or no mentoring


2 - Improper Resourcing (2)

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• The incorrect number of programmers assigned to the project - More personnel means more training and learning curve

• Frequent reassignment rather than longer and consistent assignment

• No personal choices by programmers


Resourcing Assignment Logic

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Total Hours (hr)

30 SDTM 10 30020 ADaM 10 200

100 TFL 10 1,000Total 1,500

1. Given 3 programmers• 30 hours per a week, so 3 programmers – 90 hours per a week

for 3 programmers• 1500/90 ~ 16 weeks, so about 4 months

2. Given 10 weeks• 30 hours per a week, so 10 weeks – 300 hours per 10 weeks• 1500/300 = 5, so about 5 programmers


3 - Poor Execution

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• A lack of detailed, well-thought plan• A lack of leadership• A lack of the prompt and appropriate decision

making


4 - Incorrect deliverables

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• It will be better to be a correct deliverable at the first time.

• Did not meet the expectation of clients


Example of Costs for second deliverables

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Total Hours

Programmer’s Rate

Total Cost

30 SDTM 0.5 15 $100 $1,50020 ADaM 0.5 10 $100 $1,000

100 TFL 0.5 50 $100 $5,000Total 75 $7,500

According to Budget Template, the second deliverables will cost about $7,500

Assumption: • each task takes about 0.5 hour for rerunning and revalidating


5 - Miscommunication

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Miscommunication• Miscommunication with the clients• Miscommunication within the teamProper Communication• A team needs a regular project meeting with the

clients and with the team.• A team needs to communicate the process and

current status of the projects.• A team communicates the issues or concerns

early.


How to save a budget (1)

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• Clear understanding of the projects• Detailed planning for the projects and execution of

plans. • Proper resources (e.g. keeping the same

personnel in the similar studies, proper allocation of works and so on)

• Efficiency in programming( e.g. the proper usage of macros and process).

• Effective communication – internally and externally.


How to save a budget (2)

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• Regular budget monitoring (especially at project milestone such as interim analysis)

• Monitoring the budget and adjusting the project process accordingly.

• Keeping the records of out-of-scope works –probably for the change order.


Review on budget management after study completion

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• Review the task times spent in the study. • Review the discrepancies between the contract

and the deliverables.• Review the current project process.• Gather projects’ historical data and analyze

them.


Conclusion

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• Budgeting – a programmer’s job?• A programmers wants to care about budget?• More accurate estimation • Gap analysis between contracts and

deliverables• More accurate feedback about the project and

budget


Questions?

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How to keep the project on budget in the clinical trial study

Technology

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