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Let’s Talk Clinical Research Organization (CRO)

And the winner of the Worst “CRO” goes to?

Did you think I would tell? Besides, you would think it is my opinion and not a fact. I spent most of my career working directly with sponsors (pharmaceuticals, biotechnology companies and healthcare organizations) in their goal to submit drugs for FDA approvals.

So why would I think clinical research organizations aka CROs are that bad? They help sponsors with tasks, they themselves do not have the capacity or the resources or the time for.

Let’s examine some CROs (names replaced):

CRO Q: Back in the day, I used to hear ex-employees of this CRO talk about this CRO as “a  sweatshop (or sweat factory)”. It was a good place to gain experience and move on. This CRO is still in business and with a lot of sponsor’s project. I guess, things just stay the same as long as it does not hit the bottom line ‘$$$$$‘.

CRO T: This CRO has been around under multiple names. As soon as their employees hear the phrase ‘we lost a big project’ or ‘we are about to merge again’, employees move on or leave this company.

CRO C: This CRO model is to leased out their own staff (more like a recruitment agency) than a CRO. I used to know someone who was transferred from Europe to USA under this CRO. Eventually, my friend move on into a pharma client and it is happy ever since. Why would anyone want to work for this CRO and let them leased out your skills and services when you could just register as a business and do it yourself?

If you google around, you will see many questions about salary, interviews, and career options but there are no discussion of the various work environments you might encounter at a CRO.

CRO B: I briefly worked for this small CRO and let me tell you. It has got to be the worst experience yet. Not only managers are like total control-freaks aka ‘micro-management’ but their unhealthy work environment can make you sick (open-floor). There was no sense of team work. How can you work on this kind of environment? I prefer consulting, home-based projects for reasons like this one.

I have no time for bad-managers.

CRO P: The people at this CRO that have been there the longest are the ones that make it such a horrible place to work and there are only a few of them. High turnover CRO with a passive aggressive/sabotaging culture.

CRO I: What happened to the word ‘paperless’? Instead, manual review, re-work and more paper is available. In the world where technology has advanced, this CRO still using old technologies where paper-based process are implemented for EDC-based clinical trials.

CRO P: If you have a degree in chaos, a knack for scapegoating and the top notch ability to kiss the clients ass, this is the place for you. I am not saying this, by the way. I found it online and it sure made me laugh.

CROs All: These CROs who want you to account for every minute of your day. They produce nothing, they leased out your skills and experience to the sponsors. If the sponsor goes, you might be laid off.

Discussing our clinical research experiences at different CROs is the bread and butter of this industry. With so many outsourcing, mergers, who could you work for?

As one CRA posted online “deciding which CRO to call home in the current job booming environment is more difficult than before. The CROs (especially the mid-size and large ones) are filling up all the Internet job search websites with their multiple job postings. And if you talk to any of the recruiters, they will confirm that the company they represent is the best fit for you, they value their people, have an excellent health/dental/vacation day package, and have the hard to find “work/life balance” that eludes us all. Well, the sad truth is that there is no ideal CRO fitting that description. Oh, some have their merits (and some are better than others, for sure), but ideal they are not.”

I could not have agreed better with her point of view. With all the mergers and changes in the industry in the last few years, there is a new landscape to explore.

CROs have a bad reputation for ‘high turnover’. It is too bad that this issue of turnover is not addressed from the Top level. Management is probably too busy worrying about their multi-million dollars bonuses that what is going on at the office.

Good luck and hope this article brought you some insights to the clinical research world we live in.

For a better career solution, joining an employee-owned culture is best. There a few in the industry. I represent RA eClinica.

Our company was founded on the belief that those who contribute to the company’s success should own a stake in the company and benefit from its success. Because each of us has such a high degree of trust in one another we are all more motivated to please each other and to do excellent work. We are constantly striving for perfection, together.

If you want to take charge of your life, career and freedom, join us in this quest. Note that we are not a CRO nor an EDC vendor. We would like to think of us as ‘where Clinical Research meets Technology”.

Source: MedZilla

Source: LinkedIn Pulse

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. riskplan

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 CDIDefine-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? 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.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.