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