Category Archives: Project Management


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 timecost, 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 = 400/500 = .80

Cost Performance Index (CPI)


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 = 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.


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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Team Collaboration and Conflict

Team Collaboration and Conflict

Conflict is inevitable and can be positive. Sometimes the person who disagrees actually does have a better way. Conflict is a natural result of change, but to manage it properly, we must focus on the facts, not the emotions. In other words; focus on the problem, not the person.

Ineffective team collaboration is one of the primary contributors to costly rework and delivery failure in many projects. Team collaboration is about sharing knowledge and reaching consensus within the team.

‘Problem-Solving Teams: Quality Circles’. I personally never read an article related to ‘conflict and team members with Quality Circles’ but they primary goal to foster an exchange of ideas and the use of basic tools such as brainstorming, checklists and Pareto chart, etc. were very familiar to me.

First, we should understand the major sources of conflict for a project. For instance, at the beginning of a project, project priorities, administrative procedures and schedules are the main sources of conflict. Towards the middle and end of a project, schedules create the most conflict, followed by resources, and technical issues. Personality conflicts are lower of the list, as are cost.

After we have clear understanding of what are the conflict and the sources, we can work on resolving those conflicts. Confronting the problem head-on without being confrontational towards the person is the best win-win situation. We examine alternatives with an open mind, and really agree on the best solution.

Ideally we want to build a positive relationship with positive statements all along. If you include a positive statement at the same time you address the problem, focus on the issue and be specific. For example, “I know it is not your fault but I trust that as a good team player, you will be here from now on.”

anayansi gamboa conflicts

In order to smooth the progress of conflict resolution, we should obtain feedback during the meeting and status reports; stress to the team and customer how critical it is to communicate any issues during the status meetings or at least to the project manager. Provide an explanation with the updated information.

Many projects do not deliver, and get canceled before they are completed. Team collaboration issues are very often the reason why projects fail, but if the right infrastructure is available to facilitate effective knowledge sharing among the team members, conflict will be minimize.

Source: {EDC Developer}


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Employee motivation in the workplace

Employee motivation in the workplace

The job of a manager in the workplace is to get things done through employees. To do this the manager should be able to motivate employees. But that’s easier said than done! Motivation practice and theory are difficult subjects, touching on several disciplines.

In spite of enormous research, basic as well as applied, the subject of motivation is not clearly understood and more often than not poorly practiced. To understand motivation one must understand human nature itself. And there lies the problem!

Human nature can be very simple, yet very complex too. An understanding and appreciation of this is a prerequisite to effective employee motivation in the workplace and therefore effective management and leadership.

Our articles on motivation theory and practice concentrate on various theories regarding human nature in general and motivation in particular. Included are articles on the practical aspects of motivation in the workplace and the research that has been undertaken in this field, notably by Douglas McGregor (theory y), Frederick Herzberg (two factor motivation hygiene theory,) Abraham Maslow (theory z, hierarchy of needs), Elton Mayo (Hawthorne Experiments) Chris Argyris Rensis Likert and David McClelland (achievement motivation.)

Why study and apply employee motivation principles?

Quite apart from the benefit and moral value of an altruistic approach to treating colleagues as human beings and respecting human dignity in all its forms, research and observations show that well motivated employees are more productive and creative. The inverse also holds true. The schematic below indicates the potential contribution the practical application of the principles this paper has on reducing work content in the organization.

Motivation is the key to performance improvement

There is an old saying you can take a horse to the water but you cannot force it to drink; it will drink only if it’s thirsty – so with people. They will do what they want to do or otherwise motivated to do. Whether it is to excel on the workshop floor or in the ‘ivory tower’ they must be motivated or driven to it, either by themselves or through external stimulus.

Are they born with the self-motivation or drive? Yes and no. If no, they can be motivated, for motivation is a skill which can and must be learnt. This is essential for any business to survive and succeed.

Performance is considered to be a function of ability and motivation, thus:

Job performance =f(ability)(motivation)

Ability in turn depends on education, experience and training and its improvement is a slow and long process. On the other hand motivation can be improved quickly. There are many options and an uninitiated manager may not even know where to start. As a guideline, there are broadly seven strategies for motivation.

These are the basic strategies, though the mix in the final ‘recipe’ will vary from workplace situation to situation. Essentially, there is a gap between an individuals actual state and some desired state and the manager tries to reduce this gap.

Motivation is, in effect, a means to reduce and manipulate this gap. It is inducing others in a specific way towards goals specifically stated by the motivator. Naturally, these goals as also the motivation system must conform to the corporate policy of the organization. The motivational system must be tailored to the situation and to the organization.

In one of the most elaborate studies on employee motivation, involving 31,000 men and 13,000 women, the Minneapolis Gas Company sought to determine what their potential employees desire most from a job. This study was carried out during a 20 year period from 1945 to 1965 and was quite revealing. The ratings for the various factors differed only slightly between men and women, but both groups considered security as the highest rated factor. The next three factors were;

  • advancement
  • type of work
  • company – proud to work for

Surprisingly, factors such as pay, benefits and working conditions were given a low rating by both groups. So after all, and contrary to common belief, money is not the prime motivator. (Though this should not be regarded as a signal to reward employees poorly or unfairly.)

Source: {EDC Developer}

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Posted by on June 6, 2015 in Project Management


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How Much are Bad Managers Costing Your Company?

How Much are Bad Managers Costing Your Company?

Harassment, discrimination or labor exploitation can become poison in the work environment. Bad attitude, micro-management, unqualified managers can be as toxic in the workplace.

How to cope with a toxic work environment?

We often hear in hours of leisure (lunch breaks) employees telling the terrible stories that turn their heads as the worst bosses they have ever known.

A toxic work environment is as harmful to health as smoking. That is why, some experts have provided advice on how to survive and come through with certain harmful working circumstances. In addition there are some strategies to determine why we can come to feel animosity towards our work.

How do you know if your workplace is or is not toxic? What happens to your boss or your coworkers? What to do about it ?

If all these questions come to your mind at times of tension in the company, you are probably in a toxic work environment. If you ask one or some of the following questions:

• Do you hate going to work every day?

• Does the work of two or more people, but you get paid the same salary?

• Do you feel little or no worth?

• Does your superior yells at you and your colleagues constantly?

• Have you asked for help, but nothing changes?

• Have you been asked to falsify reports?

• Have you been the victim of sexual harassment?

• Have you been the victim of discrimination based on race, sex, age, religion or sexual preference?

Toxic work

If you answered YES to one or more of these questions, you are working in a toxic work environment and this is due to people in positions of authority operate through abuse of power, ego, mistrust, paranoia, cruelty, injustice, inequality, pressure, greed, ambition and brutal disrespect that negatively effect everyone around them.

What could be possible solutions to a toxic work environment?

Of course, communicating to HR. Unfortunately, we don’t believe HR is there to help employees. We will cover Human Resources department role on a later article.

Changing Departments? Unfortunately, when you work for a very small company, this option may not be available. Even if you work a large corporation, most often than not, you won’t be able to transition to another department that easily.

Get a lawyer to write a letter to your boss, human resources and legal department, indicating that if the situation does not change, you will file a lawsuit for a hostile work environment, sexual harassment, unsafe conditions, etc. Companies hate lawsuits and bad publicity, and may well react.

When you start noticing that more full-time staff are leaving and consultants contracts terminated, you know there is a problem with the environment. There is not rapport and no team attitude among the ones left behind. The morale of the staff has been diminished by all of the coming and going of new employees. You can’t call that a ‘productive work environment’.

And if that does not work, it’s time to find a good company that respects its workers, you don’t need living in an adverse employment situation when the price to pay for your health is too high for something worth so little.

People leave managers not companies. I QUIT!

Share your bad managers moments or toxic work environments in the comment section.

Need SAS programmers? RA eClinica can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.

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Posted by on May 6, 2015 in Project Management


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Marketing without Research

The topic of marketing research is an excellent place to start learning about marketing. A marketing campaign is only as good as the research that backs it up.
Consider the case of Coca Cola introducing “New Coke”, replacing their traditional formula. The product caused such a sensation that television programs were interrupted to tell consumers.

My question to you all is this? Why did New Coke fail so miserably? What was wrong with the research that Coke did before they introduced the product ?

Focus groups are still very popular today when doing initial marketing research. I have run focus groups and participated in many.

I remember when my marketing professor in my MBA program did some consulting for the name for a new drink. The two names that he did focus group research on were “Rattlesnake Cooler” and “Cactus Cooler.” I am sure you all know Cactus Cooler now, and it is a very successful product.

anayansi gamboa Cactus Cooler

I think one of the things researchers did was a focus group. The results of the focus group were much more negative than expected so the researchers did a different survey. The results of that survey were negative, but not as much as the focus group. They already knew what they were going to end up doing and they didn’t listen to what the surveys said. With such a common product as Coke, you have to be careful with changes. They didn’t listen to what their consumers were telling them.

Think that when a mega-company like Coca Coke disregards focus group results, it shows that they really care about the profits they’re after and not keeping loyal customers. Part of the marketing department’s job is not to create the thirst for Coke, but to create the desire for Coke over another soft drink. The whole point of using a focus group should be to get a handle on what the public wants, not what the company wants the public to drink.

According to the text, “companies can conduct their own marketing research or hire other companies to do it for them. Good marketing research is characterized by the scientific method, creativity, multiple research methods, accurate model building, cost-benefit analysis, healthy skepticism, and an ethical focus.” A perfect example of this is to remember the part in the movie “Daddy Day Care” where Eddie Murphy’s character is responsible for marketing cereal to kids. What he does is holds a focus group for the kids to see if they like the cereal. Focus groups are great if researchers are willing to listen to the people they are tying to sell to.

That is an excellent point. If the people who hired the focus group professionals, they need to be prepared to listen to the results. Too often, company executives or others in the company have “pet projects” that they want to see succeed no matter what the cost. There are many cases where marketers or other high level people did not listen to what data the focus group produced.

This is a fatal mistake.

This is one reason why companies are outsourcing a lot of marketing functions because everything is so specialized. Rather than having a large internal marketing force, companies will often outsource focus groups or other research to ensure that the results are unbiased. Of course, if the company execs don’t listen, the research is wasted.

What did the focus group concentrate on?

Source: {EDC Developer}



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Happy Holidays from RA eClinica

Thank you very much for being a great reader in 2014. What a whirlwind year it has been with many new posts  being released.

Until the 5th of January please contact us using the usual methods found here. If you’re unable to get through via the phone then please leave a detailed message including your company name and phone number and we will return your call as soon as possible.

Once again we wish you a happy holiday season. We look forward to sharing a successful and exciting 2015 with all of our customers and readers.

RA eClinical Solutions 2015




Project Plan: CDISC Implementation

Project Plan: CDISC Implementation

CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research – Project Management.

As with many projects, CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a ‘Position Statement‘.

So what is CDISC? We can say that it is way of naming convention for XPT files, or field names naming conventions or rules for handling unusual data. Currently, there are two main components of CDISC: SDTM (Study Data Tabulation Model) and aDAM (Analysis Data Model).

As a project manager and with the right tool, you can look to a single source project information to manage the project through its life-cycle – from planning, through execution, to completion.

1) Define Scope: This is where you’re tested on everything that has to do with getting a project up and running: what’s in the charter, developing the preliminary scope, understanding what your stakeholders need, and how your organization handles projects.

The scope document is a form of a requirement document which will help you identify the goals for this project. It can also be used as a communication method to other managers and team members to set the appropriate level of expectations.

The project scope management plan is a really important tool in your project. You need to make sure that what you’re delivering matches what you wrote down in the scope statement.

2) Define Tasks: we now need to document all the tasks that are required in implementing and transforming your data to CDISC.

Project Tasks (Work packages) Estimates (work unit)
Initial data standards review 27
Data Integrity review 17
Create transformation models 35

The work breakdown structure (wbs) provides the foundation for defining work as it relates to project objectives. The scope of work in terms of deliverables and to facilitate communication between the project manager and stakeholders throughout the life of the project. Hence, even though, preliminary at first, it is a key input to other project management processes and deliverables.

3) Project Plan: Once we completed the initiation phase (preliminary estimates), we need to create a project plan assigning resources to project and schedule those tasks. Project schedules can be presented in many ways, including simple lists, bar charts with dates, and network logic diagrams with dates, to name just a few.

A sample of the project plan is shown below:

project plan sample

image from Meta‐Xceed paper about CDISC

4) Validation Step: Remember 21 CFR Part 11 compliance for Computer Systems Validation? The risk management effort is not a one-time activity on the project. Uncertainty is directly associated with the change being produced by a project.

The following lists some of the tasks that are performed as it pertains to validation.

  • Risk Assessment: Different organizations have different approaches towards validation of programs. This is partly due to varying interpretations of the regulations and also due to how different managers and organizations function. Assess the level of validation that needs to take place.
  • Test Plan: In accordance with the project plan and, if not, to determine how to address any deviation. Test planning is essential in: ensuring testing identifies and reveals as many errors as possible and to acceptable levels of quality.

test plan-cdisc

  • Summary Results: This is all the findings documented during testing.

An effective risk management process involves first identifying and defining risk factors that could affect the various stages of the CDISC implementation process as well as specific aspects of the project.


5) Transformation Specification: Dataset transformation is a process in which a set of source datasets and its variables are changed to meet new standard requirements.

Some changes will occur during this step:

For example, variable name must be 8 chars long. The variable label must not be more than 40 chars in length. Combining values from multiple sources (datasets) into on variable.

6) Applying Transformation: This is done according to specification however, this document is active during the duration of a project and can change. There are now many tools available to help with this tasks as it could be time consuming and resource intensive to update the source code (SAS) manually. Transdata, CDISCXpres, SAS CDI, Define-it; just to name a few.

7) Verification Reports: The validation test plan will detail the specific test cases that need to be implemented to ensure quality of the transformation. For example, a common report is the “Duplicate Variable” report.

8) Special Purpose Domain: CDISC has several special purpose domains: CO (comments), RELREC (related records or relationship between two datasets) and SUPPQUAL (supplemental qualifiers for non-standards variables).

9) Data Definition Documentation: In order to understand what all the variables are and how they are derived, we need a annotation document. This is the document that will be included during data submission. SAS PROC CONTENTS can help in the generation of this type of metadata documentation.

The last step in the project plan for CDISC implementation is to generate the documentation in either PDF or XML format.

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Need SAS programmers? We can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.


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Taking productivity to the next level


Got mobile? There are plenty of free apps and plugins available to ensure your tasks are always there for you. Pick the best and stick to it.


Integrate your mobile app with your email web tool. We like Thunderbird, as it is allows you to turn an email into a task with one click. Organize those email tasks any way you like, color code them, and add due dates and reminders.


Small tasks are easier to complete than bigger ones, so break big tasks into a number of smaller sub-tasks that can be completed in less than an hour. This will allow you to estimate the total time involved more accurately.


Efficiency is up and employee independence is maintained.

Now go ahead a scheduled a bike ride on those Dutch roads (We know. it is cold but the Dutchies like their bike lines).

What tools / apps do you use and recommend?

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Posted by on December 10, 2014 in Project Management, Tips & Tricks


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Effective Project Manager

anayansi gamboa PM plan

The art of managing projects comes with many different approaches.

There are three skill groups a project manager must have in order to be effective: a technical skills group, a project management skills group, and a people skills group (a skill group is different from a skill set, which you will see later).

First, the project manager must know what the task is all about from a technical standpoint

Second, a project manager must possess project management skills—that is, the ability to create schedules and budgets, the ability to implement and manage change control systems, the ability to implement and manage risk management systems, and the ability to implement and manage the many other project management skills as well project manager must possess the so-called ‘‘Soft’’ skills. These skills are frequently called the people skills: The ability to get things done, and the ability to anticipate problems.

Here’s a scenario of a project manager leader:

During the project the leader must continue to treat the {EDC} Hands-On team, keeping them informed and closely coupled with the in-house {EDC} team members. He must continue to highlight to the team upcoming dependencies between groups.

The new liaison manager must promote frequent exchanges of information that will show what progress is being made and highlight immediately any misunderstandings regarding project or product goals.

As part of a team-building activity, {EDC} manager offered certain incentives to both site (first-class air fare, hotel accommodations, etc) in order to improve communication and collaboration between the two teams.

The {EDC} team members must be fully assessed against the alignment factors for their suitability for this job.   For each factor the liaison manager must identify possible issues, discuss them with the potential team member, and make a conscious decision. The following questions can aid the liaison manager in his assessment:

  • Are metrics of team performance collected and analyzed on a regular basis throughout the project?
  • Is regular feedback provided by management on team and individual performance?

Frequent interim informal reviews should be held on works in progress such as requirements specifications and designs, to uncover misunderstandings as early as possible.

In order to overcome the problems encountered in the past, the {EDC} team established weekly meetings between both teams. The project manager is responsible to build a positive, supportive atmosphere where team members operate cohesively.

So does your organization give ownership and empowerment to their employees?


When a mixture of ideas and backgrounds come together in a group to design a project, it’s expected to have variations. There is no single right way to performing all the tasks needed as long as each is done with appropriate precision. This kind of diversity prepares a project for success if everyone is willing to work towards the common goals of the organization.

If a company believes that those who contribute to the success of the organization should benefit from its success then it must allowed for their project manager to work together with their team members to accomplish the end goal. As it is, employees would feel part of the big picture because they care. It’s not just investing in a company; it’s investing in themselves, their performance and their future.

Source: {EDC Developer}

EDC Developer Consultant and clinical programmer available for ad-hocs and short-term projects.



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Data Management Plan in Clinical Trials

The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning.

This article is an extract from EDC Developer blog. Click here to read it. Data Management Plan in Clinical Trials.

RA eClinical Solutions provides clinical Data Management, Project Management and Technology Support within the Life Science community.


Source: EDC Developer


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