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Key Considerations for Clinical Trial Specimen Collection

laboratory technician working with clinical specimen and other equipment

The Importance of Specimen Collection

Bringing new, life-changing therapeutics to market cannot be accomplished without vital data about patient impact in clinical trials from thousands of test subjects over an extended period of time. Sometimes this can mean hundreds of thousands of managed specimens over the course of a study – which is no small task. 

To accurately understand the impact of a new therapeutic modality on patient health and outcomes, sponsors and CROs depend on reliable and accurate test results. And, ensuring the accuracy of test results relies heavily on exemplary specimen collection and sample integrity throughout the process.

Common Clinical Specimen Collection Challenges

Regardless of central lab preparation, unforeseen challenges can occur throughout the specimen collection journey, and small human error mistakes can lead to timely and expensive fixes. 

Some common problems in the clinical trial space with regard to collecting specimen samples include:

  • Unintended use of expired containers
  • Incorrectly labeled specimens
  • Insufficient quantities of specimens (QNS – quantity not sufficient)
  • Incorrect tube selection for test requirement
  • Unfollowed patient instructions prior to sample collection
  • Unclean or contaminated specimen

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Choosing Bulk Supplies vs Collection Kits

Managing clinical trial specimens on a global scale is no easy feat. Central labs and biobankers must account not only for adequate sample collection items, but also manage storage space, a specimen database and more. When it comes to gathering samples, most organizations focus on two primary methods: bulk supplies and collection kits

While bulk might seem like it would offer the most utility, due to large quantities of supplies being shipped to clinical sites, the method relies heavily on the experience of the clinical staff and assumes all supplies will be used appropriately.

ACM’s Recommendation for Specimen Collection

This is why ACM Global Laboratories prefers the collection kit method. Utilizing this method, ACM sources and procures materials globally to develop individual kits containing everything needed for sample collection. 

These kits are prepared in advance and make the job of the clinical staff easier – all they have to do is open a new kit for each study participant. These kits also ensure proper use, and the correct quantity of samples will be collected, therefore also ensuring sample quality.

What to Prioritize When Building Collection Kits 

1. Reliable Sourcing

At ACM Global Laboratories, we understand the criticality of receiving your laboratory supplies intact and on time – that’s why we proactively source our own materials from a multitude of suppliers to reliably deliver our kits on site as promised. What’s more, we have a dedicated sourcing team who works to maintain a 60-90 day supply of kit stock items to help ensure consistent availability.

2. Timeline Pressures

Typically, collection kits can take several weeks to assemble and ship, therefore if samples are needed on an ASAP timeline, proper planning will be required to meet those deadlines. If the study is routinely dynamic, a bulk supply method might be the more efficient option, however, ACM recommends and prioritizes kits to manage studies because they ensure high sample quality. 

3. Tracking for Sample Management

Collection kits can be designed with specific supplies that can be barcoded and tracked through sample management tools such as ACM’s Client Portal, and if non-standard supplies are necessary for the study, bespoke options can be sourced.

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Patient Preparation and Sample Collection

Utilizing the preferred sample kit method, careful attention to detail and routine must still be adhered to in order to guarantee sample quality – because a poorly collected sample may not qualify for study admittance. It is important to gain the patient's understanding and cooperation in obtaining an acceptable specimen. 

The ACM Clinical Kits Advantage

Part of what makes ACM Global Laboratories such a trusted partner is the fact that we only commit to the studies we know we can support. 

When it comes to bidding on a trial, ACM utilizes our in-house team to review and vet RFPs for availability of supply and work throughout the duration of study to help ensure timely delivery in adequate quantities. We are mindful of a kit’s shelf life and how it impacts each and every study – so we send kits out the door with a multiple-month expiry where possible, to help keep you focused on the work instead of worrying about the shelf life of your materials.

overview of acm specimen collection kits supply chain

ACM Supply Chain Overview

ACM and our diligent team created a transparent end-to-end process to ensure our clients are satisfied with their kit experience. 

GLOBAL PURCHASING

  • ACM maintains a large global network of suppliers with worldwide delivery capabilities so our logistics are seamless
  • Our team diligently manages our vendor relationships and vendor qualification process to ensure standard laboratory supplies and reagents for all testing portfolios

MATERIALS AND INVENTORY MANAGEMENT

  • We monitor and adjust the stocking levels based on reorder points, critical items, long lead time, supplier location and risk, expiration dates using our Inventory and Order Management Systems to keep trials running smoothly
  • ACM communicates material issues in advance to the project managers and business development team member to notify clients so that we can find the best path forward together
  • Our experts ensure mitigation plans are in place, to include alternate supply, increase safety stock, sourcing from other regions, escalate locally

KIT BUILDING AND SHIPPING

  • We make reliable kit building and shipping available in-house in York, England and through a contracted vendor in Rochester, NY.
  • Our team is capable of providing expedited services subject to order timing and complexity

COURIER MANAGEMENT

  • ACM’s large Global network of couriers have worldwide pickup and delivery capabilities as well as temperature controlled shipments to ensure specimens arrive quickly and safely
  • Our logistics team monitors daily shipping exceptions (delays) for kits and specimens

COMMUNICATIONS

  • We execute periodic communication to the project manager and business development team member with a just-in-time communications strategy for critical issues about materials or shipping concerns should those arise
  • ACM sends timely emails to sites to provide support and guidance for changes in instructions

Let’s Talk About Your Kit Needs

We can help navigate the complexities of transporting samples globally by validating compliance with local regulations, managing couriers and shipments and providing shipping options that optimize cost and efficiency. From the RFP process all the way to kit supplies and delivery, at ACM we do things differently. 

We’ll treat you with the focus you deserve so your study runs smoothly and successfully. Learn more about our Clinical Specimen Collection Kits or Contact Us today.

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Get your clinical specimen collection kits delivered on site, on time, and intact. Contact ACM to discuss your specific kit needs.

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