Only a few years out of college, I thought the title sounded impressive. In actuality, I soon found myself pouring over hundreds of spreadsheets, sent from all over the world, trying to figure out what samples were available to analyze, and what was missing.

When emails and phone calls were not effective, I often resorted to hopping on a flight and personally digging through freezers in order to locate a handful of samples needed to close out a trial.

Simple miscommunications or clerical errors can be the difference between the success and failure of a clinical trial. However, many clinics and labs are still tracking their sample inventory on spreadsheets as they did 10 years ago.

This method may be adequate for small labs with a close team, but it proves ineffective in multi-center clinical trials. Most clinical trial protocols depend heavily on the analysis of biological specimens to meet study endpoints.

Sample collection requirements in these trials are becoming increasingly more complex due to the focus on biomarker analysis and precision medicine. Sponsor organizations are also choosing to preserve a larger number of biological specimens for future research efforts.

It is no longer enough to reconcile a check box on a Case Report Form CRF with results data to ensure the required samples were collected and analyzed. These types of things should be reported in detail so that intervention can be made quickly and in real time.

At a minimum, any sample management solution should be able to answer the following questions:. Recording this specific information upfront will be invaluable later when investigators ask why data is missing, and will greatly reduce the amount of queries sent to the site.

With Software Developer being 3 on the US News Top Jobs for , there is no shortage of talented engineers willing and able to create all kinds of software to track clinical trial samples.

Often the barriers to the adoption and success of a sample management project has very little to do with the software you choose, but how you choose to implement it.

Some of the common arguments for resistance to using sample tracking software include:. This type of hosting is also typically less expensive since IT resources are shared among many customers.

As technologies that work seamlessly together have become more commonplace in our personal lives, we now have the same expectation of simplicity in our professional endeavors as well.

In order to lighten the burden on your site users, look for software that is configurable to your business process and study requirements.

By informing the system of expectations prior to study start, less entry is required by the site. For example, you may be able to leverage barcode label information provided by kit manufacturers to eliminate the need of hand entering collection tube and specimen details.

To further reduce data entry, the sample management application you choose should also allow information to be imported or synced from other systems such as Electronic Data Capture EDC , Laboratory Information Systems LIS , and Clinical Trial Management Systems CTMS. To support these integrations, care should be taken to build a common vocabulary and data structure so that data is recorded in a consistent manner.

Regardless of the challenges you may face in implementing a sample management solution, there are a couple ways you can streamline your sample inventory needs.

Often, the easiest strategy to adopt is creating a virtual sample repository for the items collected in your individual trial or program. A virtual repository compiles sample information received from each of your sites and labs and merges it together into a single database.

This can be done with a file import or through web service integration. By using the free trial software, you agree to use it for evaluation purposes only. It is not to be used for actual research, study planning, or otherwise, whether academic, commercial, government or education. The PASS free trial gives you an opportunity to evaluate the software with a restriction on alpha before you purchase it.

When you click the download button with a valid email address, you can begin downloading the PASS sample size software setup file. You will receive an email with your trial license key that allows you to evaluate the software for 30 days.

If you choose to purchase the software, you can use the license key you receive to convert the trial version into the fully-functional version. You will not need to reinstall PASS sample size software after you purchase a license.

You can unsubscribe at any time. Your email address will never be sold or given to a 3rd party. PASS will never collect nor transmit any data or settings that you input into the software, any data related to intermediate calculations, nor any output data or results that are generated by the software.

PASS will report the types and frequency of the procedures and tools being used. This will help us better understand which procedures and tools are most-often used and identify potential improvements.

PASS is compatible with Windows only. Click here for a complete list of system requirements. A Windows emulator such as Parallels is required to use PASS on a Mac.

Click here for more information. Trouble Downloading? Get help downloading the PASS Free Trial by contacting us. As Statistician teaching statistics in the University, I have to say that NCSS is the tool that I have used since With all the procedures that you need for research or to make a good, informative presentation, it can be used for teaching in a university.

Here in Idesem-Chile we have found it to be the best tool to support our measurement activities. I recommend this tool to make your job more enjoyable!

Let's start with four companion products from Lit Software that facilitate trial preparation and presentation: TrialPad, TranscriptPad Missing The Hospital Inpatient Free Trial Program (HIFTP) provides UZEDY to eligible inpatient hospitals that cannot accept Prescription Drug Marketing Act

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Sample trial programs - Clinical sample tracking helps research teams know where samples are in the receiving, storage, testing and analysis process Let's start with four companion products from Lit Software that facilitate trial preparation and presentation: TrialPad, TranscriptPad Missing The Hospital Inpatient Free Trial Program (HIFTP) provides UZEDY to eligible inpatient hospitals that cannot accept Prescription Drug Marketing Act

This method may be adequate for small labs with a close team, but it proves ineffective in multi-center clinical trials. Most clinical trial protocols depend heavily on the analysis of biological specimens to meet study endpoints.

Sample collection requirements in these trials are becoming increasingly more complex due to the focus on biomarker analysis and precision medicine.

Sponsor organizations are also choosing to preserve a larger number of biological specimens for future research efforts.

It is no longer enough to reconcile a check box on a Case Report Form CRF with results data to ensure the required samples were collected and analyzed. These types of things should be reported in detail so that intervention can be made quickly and in real time.

At a minimum, any sample management solution should be able to answer the following questions:. Recording this specific information upfront will be invaluable later when investigators ask why data is missing, and will greatly reduce the amount of queries sent to the site.

With Software Developer being 3 on the US News Top Jobs for , there is no shortage of talented engineers willing and able to create all kinds of software to track clinical trial samples. Often the barriers to the adoption and success of a sample management project has very little to do with the software you choose, but how you choose to implement it.

Some of the common arguments for resistance to using sample tracking software include:. This type of hosting is also typically less expensive since IT resources are shared among many customers.

As technologies that work seamlessly together have become more commonplace in our personal lives, we now have the same expectation of simplicity in our professional endeavors as well. In order to lighten the burden on your site users, look for software that is configurable to your business process and study requirements.

By informing the system of expectations prior to study start, less entry is required by the site. For example, you may be able to leverage barcode label information provided by kit manufacturers to eliminate the need of hand entering collection tube and specimen details.

To further reduce data entry, the sample management application you choose should also allow information to be imported or synced from other systems such as Electronic Data Capture EDC , Laboratory Information Systems LIS , and Clinical Trial Management Systems CTMS.

To support these integrations, care should be taken to build a common vocabulary and data structure so that data is recorded in a consistent manner.

Regardless of the challenges you may face in implementing a sample management solution, there are a couple ways you can streamline your sample inventory needs. Often, the easiest strategy to adopt is creating a virtual sample repository for the items collected in your individual trial or program.

A virtual repository compiles sample information received from each of your sites and labs and merges it together into a single database. This can be done with a file import or through web service integration. The advantage of this type of system is that each site can continue to use their preferred data collection method.

However, because data is collected in various formats, work will be required to ensure the data is consistent, and there may be holes in the sample custody or data received from the site. The preferred option would be to implement a transactional system that records the sample information at each stage of the lifecycle, resulting in a full picture of how a sample was collected, processed, and transferred.

The system may also include storage management allowing you to not only know which site or lab is in possession of the sample, but also where it is located in the building, and how many times it has been in and out of the freezer.

Whether or not your organization will choose to implement a new system or improve on the one currently in place, my hope is that the clinical research community will continue to invest in more streamlined and efficient sample management processes. A Windows emulator such as Parallels is required to use PASS on a Mac.

Click here for more information. Trouble Downloading? Get help downloading the PASS Free Trial by contacting us. As Statistician teaching statistics in the University, I have to say that NCSS is the tool that I have used since With all the procedures that you need for research or to make a good, informative presentation, it can be used for teaching in a university.

Here in Idesem-Chile we have found it to be the best tool to support our measurement activities. I recommend this tool to make your job more enjoyable! D , AIU, CEO. Copyright © NCSS. All trademarks are the properties of their respective owners. Privacy Policy Terms of Use Sitemap.

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