Tag Archives: freelancer

Cracking the Code: Estimate at Completion (EAC) of a Clinical Trial

Project management is a continuous loop of planning what to do, checking on progress, comparing progress to plan, taking corrective action if needed, and re-planning. The fundamental items to plan, monitor, and control are time, cost, and performance so that the project stays on schedule, does not exceed its budget, and meets its specifications.  Of course all of these activities are based on having an agreed upon Work Breakdown Structure (tasks/activities) on which to base the schedule and cost estimates.  During the planning phase of a project, the project manager with the assistance of the project team needs to define the process and procedures that will be used during the implementation phase to monitor and control the project’s performance.

Productivity in the pharmaceutical/biotech/medical device industry is going down. Some compounds have reached the billions expenditures cost without any guarantee that it will ever be approved or reach the market.  So how can we evaluate the performance of some of these clinical trials?

I will not go into details in the degree of project management activities managed and performed by a data manager since this can vary widely per company.  A good clinical data manager or manager of data management should be able to implement basic PM principles that will improve quality and timeliness of a clinical trial, regardless if the trial is fully outsourced (e.g. CRO performed most of the work).

You can find my article about the Role of Project Management in Clinical Data Management (2012) here for further reading.

So what is Estimate at Completion or EAC? or What is the project likely to cost?

There are several methods we could use to calculate EAC.

Let’s look at one formula. EAC =  AC (Actual Cost) + ETC (Estimate to Complete)  so what happens when you don’t know the ETC?

We could use the following formula to derive that value: ETC = (BAC – EV) / CPI =>>>>??? So what? More formulas? How do I get BAC or EV or CPI?

Let’s look at those in more details.

 BAC =>>>Budget at Completion (how much did you
budget for the total project?)
CPI =>>> Cost Performance Index (CPI): BCWP/ACWP

EV = Earned Value

Earned Value Analysis example for a phase 1 trial (*figures in the thousands / millions = fictitious  numbers)

The final clinical trial results includes 100 subjects. The estimated cost is $20 per subject.  That results in an estimated budget of $2000 (100 x 20). During the planning, the CRO indicated that would be able to enroll 5 subjects per week.  Therefore the estimated duration of the trial is 20 weeks (100 / 5)

EV blocks: From the project plan

Estimated Budget: $2000

Estimated Schedule: 20 weeks

Planned Value (PV): at the end of the trial is $2000

Variance between planned and actual at the end of the first week:

Based on the estimated scheduled, I should have 25 subjects enrolled. At $20 per subject, the planned value at the end of the week is $500 (25 x 20)

PV = $500

At the end of the first week, the CRO reports that he has enrolled 20 subjects  and the actual cost of that study is $450. With this information we can look at schedule and cost variance.

SV = EV – PV

SV = $400 – $500 = – 100 ($100 work of subject recruitment is behind schedule).

CV = EV – AC

CV = $400 – $450 = -50 ($50 work of the project is over budget)

*negative figures means bad.

Using early results to predict later results:

Schedule Performance Index (SPI)

SPI = EV/PV

SPI = 400/500 = .80

Cost Performance Index (CPI)

CPI = EV/AC

CPI = 400/450 = .89 –> over budget or expending more

These rations can be used to estimate performance of the project to completion based on the early actual experience.

Estimate to Completion (ETC)
ETC= (PV at completion) – EV)/CPI

ETC= (2000 – 400)/CPI

ETC = (1600/.89) =$ 1798 from end of week one (after 5 days) and it will take additional $1798 to complete the study

Estimate at Completion (EAC)

EAC = AC + ETC

EAC = 450 + 1798 = $2248

If nothing changes, based on the actual results at the end of the first week, the study is estimated  to cost $2248 (rather than the planned cost of $2000) and will take 20 percent longer.

The formulas assumes that the accumulative performance reflected in the CPI is likely to continue for the duration of the project.

You do not need to memorize all of these formulas. There are plenty of tools in the industry that does the computation for you. But if you do not have it available, you can use Excel, set-up your template and plug in the numbers.

Earned Value

 

 

 

 

 

 

 

As per PMI – PMBOK definition, Cost management “…includes the processes involved in estimating, budgeting, and controlling costs so that the project can be completed within the approved budget.”   A Guide to the Project Management Body of Knowledge (PMBOK® Guide).

We have shown you, that PM tools such as Earned Value  Analysis, can be applied to clinical trials or specific work break down (WBS) activities within the data management team.

Based on the above outcome of the project performance related to the schedule, the data manager should be able to determine if she should modify the current plan or revise the original plan.

It is a perfect tool for data managers and managers of data managers and could be part of your risk based processes.

If bringing efficiency, improving data quality and significantly reducing programming time after implementing CDISC standards is on your radar screen, I’d love to chat when it’s convenient. All the best.

Anayansi Van Der Berg has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical. SAS, CDASH/SDTM (CDISC standards implementation and mapping), SAS QC checks and clinical data reporting.

Source:

A Guide to the Project Management Body of Knowledge (PMBOK® Guide).

Notes from my PM class at Keller 2007-2009

Images – Google images

FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

Advertisements

Your Strongest Characteristics

The reason I am writing is that I am looking for a new challenge and I felt we might have some areas for discussion, or at least you might be able to point me in the right direction.

My services basically represent a low-cost alternative to the traditional consultancy companies, which usually demand high prices for their services. My services are always the right partner for you – no matter if you are looking for an interim solution due to personnel shortage in your company, if you demand creative and unconventional solutions or if your project requires up-to-date knowledge – direct cost savings.

My current work and skills:

I’m currently working on several initiatives but there is always room for new challenges. I hold a project management degree and several certifications in different fields.

 My style?

I’m a quick-learner, flexible to change, achievement oriented and proactive.

 What you will gain from working with me:

  • Clarity on what you want
  • Tools and approaches for getting it
  • Insight into your patterns that work and roadblocks that don’t
  • An ability to see options and take action, in other words, results.

 What you can expect from me:

Honesty, straightforward yet sensitive advice and confidentiality.

Are these the kinds of skills you look for in a project leader?

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

As the 3 C’s of life states: Choices, Chances and Changes- you must make a choice to take a chance or your life will never change. I continually seek to implement means of improving processes to reduce cycle time and decrease work effort.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on latest news, articles, and tips. I am available on LinkedIn. Connect with me there for technical discussions.

Dealing with Challenging Clients

1. The Creeping (Scope Creep) Client
The creeping attack is characterized by an initial agreement to implement a set of agreed upon features by a series of repeated requests for new functionality and additions that were never discussed.

2. The Low Ball Client
The single minded focus on the price of the project right from the beginning.

3. The Octopus Client
This is characterized by micromanagement. The many hands of the octopus reach in and try to control every aspect of the project, effectively overriding your judgements and experience.

4. Attack of Urgency Client
It is characterized by a series of blindingly fast requests that you are expected to deal with at a moments notice.

Choose a job you love, and you will never have to work a day in your life.

5. Hands On Hands Off Client
This consists of the client doing or saying very little if anything at all. With no feedback to go by, good or bad, the freelancer is more less left to make best guess and hope it sticks.

6. Golden Peacock Client
This client essentially dazzle you with “you should be lucky to work for this client or company for this project ABC” so you work for next to nothing for the glory of working on the project in the first place.

7. The Extortionist Client
It is one that you don’t ever want to deal with. Essentially, this client uses money to control you and don’t pay services on time.

8. Crouching Tiger Client
Essentially the client baits the freelancer with the promise of future riches and success if they are willing to take a hit now and wait and give the client the sale of the century on this project.

9. The Dream Client
They are rare but they do exist. They pay on time, express appreciation for your work, treat you with respect and they have realistic expectations and timelines.

Source: appBuilderTV.com

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

anayansi gamboa