Monthly Archives: May 2015

Solving Data Collection Challenges

Solving Data Collection Challenges

Cross-partnership between sponsors and CROs for the collection and analysis of clinical trial data are complex. As a result there are a number of issues encountered during the running of  trial.

As with many projects, standardization projects like 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‘.

 Data Collection

According to the WHO, data collection is defined as the ongoing systematic collection, analysis, and interpretation of health data necessary for designing, implementing, and evaluating public health prevention programs.

Sources of data: primarily case report books or (e)CRF forms, laboratory data and patient report data or diaries.

 Challenges of data collection

It is important for the CROs / service providers to be aware of the potential challenges they may face when using different data collection methods for partnership clinical studies. Having several clients does not mean having several standards or naming conventions. This is the main reason why CDISC is here. So why are many CROs or service providers not using CDISC standards?

Another challenge is time limitations. Some clinical trials run for just a few weeks / months.

It may be found difficult to understand the partnership in the amount of time they have. Hence, most CROs and service providers prefer to perform manual mapping at the end of the trial, hence, re-work and manual work.

Funding also plays a key challenge for CDISC-compliance data collection study. Small researchers or biotechnology companies that do not have the resources in-house, out-sourced this task to CROs or service providers and are not interested whether it is compliance as long as it is save them money. But would it save money now instead of later in the close-out phase?

If there is a shortage of funding this may not allow the CRO or service provider all the opportunities that would assist them in capturing the information they need as per CDISC standards.

We really don’t have the level of expertise or the person dedicated to this that would bring, you know, the whole thing to fruition on the scale in which it’s envisioned – Researcher

Role of the Library

There is a clear need for libraries (GL) to move beyond passively providing technology to embrace the changes within the industry. The librarian functions as one of the most important of medical educators. This role is frequently unrecognized, and for that reason, too little attention is given to this role. There has been too little attention paid to the research role that should be played by the librarian. With the development of new methods of information storage and dissemination, it is imperative that the persons primarily responsible for this function should be actively engaged in research. We have little information at the present time as to the relative effectiveness of these various media. We need research in this area. Librarians should assume an active role in incorporating into their area of responsibility the various types of storage media. []

Review and Revise

At the review and revise stage it might be useful for the CRO or service provider to consider what the main issues are when collecting and organizing the data on the study. Some of these issues include: ensuring sponsors, partners and key stakeholders were engaged in the scoping phase and defining its purpose; the objectives have been considered; the appropriate data collection methods have been used; the data has been verified through the use of multiple sources and that sponsors have approved the data that is used in the final clinical data report.

Current data management systems must be fundamentally improved so that they can meet the capacity demand for secure storage and transmission of research data. And while there can be no definitive tools and guideline, it is certain that we must start using CDISC-standards from the data collection step to avoid re-inventing the wheel each time a new sponsor or clinical researcher ask you to run their clinical trial.

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.



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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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