Manage Clinical Trials in a Laboratory Information Management System (LIMS)
May 18

Manage Clinical Trials in a Laboratory Information Management System (LIMS)

In the current COVID-19 pandemic more people than ever are aware of the critical role clinical trials play in finding treatments and cures to disease. Tens of thousands of generous volunteers have signed up to take part in the various global COVID-19 trials. While the rest of us wait patiently for their outcome and thank those taking part and running them. Hoping that soon we’ll be one step closer to finding potential treatments. Many organisations running clinical trials use spreadsheets to manage their data. Others may use software provided or created by clinical research organisations (CROs). But wouldn’t it be easier if you could use a Laboratory Information Management System (LIMS) to manage your clinical trials? Then you’d be able to see and access all your sample data from one system.

Achiever Medical is a LIMS that enables you to do just this – allowing you to manage all your biobanking, clinical trials and discovery activities in a single system. While still ensuring that your teams only have access to the data they need.

Managing your studies

When it comes to setting up clinical trials it’s all about clarity, consistency, ethics, accuracy and flexibility.

You need flexibility as each clinical trial may be different in, for example:

  • the number and types of participants,
  • its duration,
  • its objectives,
  • the samples collected,
  • its consent requirements.

But within each trial you need to have clarity, consistency, ethics and accuracy. So, you’re collecting the right samples at the right time under the right conditions for the relevant participants.

Achiever Medical allows you to define each clinical trial along with its parameters, protocols, ethics and collection schedules. You can also define what samples you want to collect on each visit and track these even if a 3rd party is collecting and managing them offsite.

Everything you need to know about your participants

When it comes to managing and tracking clinical trials it’s as much about the participants as it is the samples.

You may feel like you’re walking a tightrope when thinking about holding participant information. On the one hand you want to hold as much lifestyle, demographic and medical history data as possible about your trial participants. On the other you want to protect their privacy and sensitive information.

The good news is that you can do it.

You need to be very clear about what you classify as personal identifiable data (PII) and protect this. Achiever Medical, for example, provides encryption at source for PII.  Plus, you can manage who has access to this level of data at project-level.

That’s if you even need to hold PII information at all in your LIMS. You could simply hold a participant reference in the system instead of a name. Or a year of birth, for example, rather than the full birth date.

You can then confidently analyse your participant profile information along with sample and results data to look for possible patterns and commonalities.

Reconciling what you’re expecting against what you’ve received

Achiever Medical provides core LIMS sample management functionality including receipting, storing, processing and dispatching samples. Standard prebuilt workflows, that can be configured to your requirements, make sure you are managing and recording your samples and associated data consistently. The software also has a data import tool to import new and update existing data.

All this allows you to record participant visits and samples collected – whether this is captured manually or imported from an external file such as a spreadsheet.

The system also provides you with a complete audit trail as you update and process samples.

Interactive, real-time dashboards in Achiever Medical allow you to see expected visits and samples versus actual visits attended and samples collected. And if a participant withdraws the system automatically adjusts the expected figures. But, importantly, you can still review when and why participants withdraw.

Quick off the mark – setting up collaborative studies in minutes

Achiever Medical is a web-based LIMS that you can host on premise or in the cloud – enabling you to quickly set up clinical trials.

All this means that you can create new studies and trials whenever you need them. And you can securely allow others – including those from other organisations – access to selected functionality and information. Allowing you to create truly collaborative trials and studies.

Maximising every sample

At the end of a clinical trial you may have unused samples. Depending on the consent you may be in a position to reuse those samples as part of other research or discovery activities.

Achiever Medical enables you to manage any samples that you can reuse securely and allows you to make them available for researchers to request. You can then decide to approve those requests. What’s more, because informed consent is linked in the system both you and researchers can ensure you use the samples in line with any consent restrictions.

This helps you make sure you use every sample for its intended purpose. Plus, you’re making the most of your valuable resources and storage space.

Using Achiever Medical LIMS to support clinical trials

Achiever Medical provides you with functionality to define and manage your clinical trials and associated participant, visit and sample information. You can use the system to just manage your trials. But its unrivalled value comes from its unique ability to manage clinical trials, biobanking and discovery workflows and data in one system.

Whether you’re managing clinical trials internally or have a 3rd party managing trials on your behalf, the samples collected are part of your inventory. Even if you don’t physically hold them at your site it’s important that you consistently and accurately track them. Achiever Medical enables you to track all your samples – whether held on or offsite.

By using Achiever Medical you can get a consolidated view of all your sample holdings which can:

  • Save you money as you’re using and supporting a single system
  • Encourage you to reuse samples where feasible to make the most of your valuable resources
  • Help you to build up detailed participant profile data against all your samples to increase their value to research.

About The Author

Sharon Williams has over 20 years’ experience of helping businesses successfully implement Sample Management Software and CRM systems. Appreciating that the software will deliver significant business change and improvements, Sharon guides businesses to help optimise these benefits. This includes advice on how to obtain user buy-in, evaluating and redefining existing business processes and how to gain a better understanding of their data to provide invaluable insight and inform business decisions.