7 (Audio) Books You Should Read in 2018

Do you want to be successful? Looking for your life purpose? Are you feeling down? Unmotivated? Lost? Do you want a better career or business? The following books have helped me obtain the life I desire and guide me through difficult times.

My goals and desires are different than yours but I am sure you will benefit from these books. If anything, you will feel motivated again and eager to embark on a new life. Good luck and share your success stories.

  1. The Richest Man In Babylon –  Napoleon Hill

2.  The Strangest Secret by Earl Nightingale

3. Think And Grow Rich  –  Napoleon Hill

4. Change your life in 20 minutes – Earl Nightingale

5.  Use This For 30 days and Watch Your Prosperity Grow! – Catherine Ponder

6.  W. Clement Stone and Napoleon Hill – Success Through A Positive Mental Attitude

7. Ask and it is Given – Abraham Hicks

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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

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Pentacles – A New Beginning – You become what you think about

Prepare yourself for a new year. Make a list of your resolutions. Write your goals down and create a discipline to manifest them into reality.

Something good is coming. Open your heart to receive it. The universe wants to give you something new. A new job, a new opportunity. This is something new.

You have done the work and finally the universe wants to give you a gift. This is magical. An unexpected gift that you have work hard for it.

Let the new come in.

The information you received was hurtful and painful but it will give you a change you need for the new beginning.

Those were some of the words I heard during my regular self-communication. I use a combination of tarot cards and other spiritual sources to find the guidances I need when in doubt.

Recently I wrote an article about success and law of attraction and how you can bring what you desire closer and closer to you.

Read more about it here: One-Year Success Plan

Ace of Pentacles

Work: You may be moving to a new position or a new set of responsibilities. If you’re wondering whether or not to leave your current position, this card is an encouraging one to see. This new position may happen whether you are looking for it or not. Either way, this is good news.

8 of Pentacles

Work: If you are seeking employment, this card can indicate that you will be hired into a new position that tests your skills and is demanding. Have faith in yourself, that you can do what is needed to be successful in the position. If you are currently working, you may be saddled with far more responsibility and tasks than can be accomplished well. Don’t hesitate to request assistance from supervisors with prioritizing. You can only do so much; be realistic.

9 of Pentacles

Work: If you’re looking for a position, the 9 of Pentacles could well point to a better job coming your way than you would have thought possible. Even if you’re currently employed, expect a change for the better, both in terms of your circumstances and your pay. You’ll have a lot to be grateful for.

 One of your dreams is on its way to coming true

Change, change, change – the universe wants to give you a wonderful gift. The hard work has paid off.

Source:

images courtesy of google image

http://www.psychic-revelation.com/

http://littleredtarot.com/nine-of-pentacles/

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Freelancer / Consultant / EDC Developer / Clinical Programmer

* Setting up a project in EDC (Oracle InForm, Medidata Rave, OpenClinica, OCRDC)
* Creation of electronic case report forms (eCRFs)
* Validation of programs, edit checks
* Write validation test scripts
* Execute validation test scripts
* Write custom functions
* Implement study build best practices
* Knowledge of the process of clinical trials and the CDISC data structure

 

Motto of the Month: Let them Walk

When people can walk away from you, let them walk.

When people can walk away from you, let them walk.

Just sit down. I don’t need to make aftercall or nothing. I don’t have the hoop, I don’t have to make you shout.

When people can walk away from  you you, let them walk.

Don’t try to talk another person into staying with you, loving you, calling you, caring about you, staying attached to you, I mean hang up the phone.

When people can walk away from you, let them walk.

I don’t care how wonderful they are, I don’t care how attractive you are to them, I don’t care what they did to you 20 years ago, I don’t care what the situation is.

When people can walk away from  you, let them walk.

Because your destiny is not tied to the person who left. Your destiny is never tied to anybody that left. People leave you because they are not joined to you. You can get super glue and you can’t make them stay.

Let them go!

And you got to know when people part in your story is over so that you don’t keep trying to raise the dead. You gotta know when its dead.
When your boy is dead wash your face and have another baby. You got to know when its over.

If they left you its no accident. If you tried to make it work, and it wouldn’t work its no accident. Accept it as the will of GOD. Clap your hands, wash your face, do your dance and keep going.

Let me tell you something. I got the gift of goodbye. I believe in goodbye. Its not that I am hateful. Its just that I am faithful.  I know whatever GOD needs for me to have, he will give it to me. And if it takes too much sweat I don’t need it.

Stop begging people to stay.

Let them GO!

Source: TD Jake sermons and google image

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“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.”