Custom IVD Collection Kits

  • Accommodate any size project from several kits to thousands of kits, shipped to multiple sites
  • Design collection kits for clients
  • From simple to elaborate (binders, custom labels, boxes, etc.)
  • Can provide all supplies for kits
  • Train sites on use of collection kits
  • Electronic bar-code audit trail for all kits and components
  • Flexible production scheduling to meet your project timeline
  • Unparalleled quality and customer service

Our kit production facility is located in Coconut Creek, FL and from here, we deliver the kits to investigator sites in the USA, South America, Europe, Asia and Africa. Our professional project management team produces the highest quality kits and unmatched QC measures to assure accuracy. We employ skilled personnel and experienced project managers to personally produce, QC and ship your kits. The use of consistent lots of supplies helps to reduce supply variation and improve supply management for your kits.

Boca Biolistics’ produced collection kits are stored at our facility until ready for shipment to your study sites. These kits are then shipped via the most efficient and cost-effective way utilizing our relationship with some of industries best courier companies. Reliability is the most important factor when shipping kits to sites as these studies are most often time sensitive. Boca Biolistics personally chooses couriers that have the capability to perform to our standards and these couriers must pass our strict vendor audit process.

QA/QC

  • Quality Assurance of kits is a top priority
  • Can be a third party QA check for collection kits made by another vendor
  • QA starts with the initiation of the project and does not end until each assembled kit is accounted for and verified by each site

Quality assurance of collection kits, whether assembled by our team at Boca Biolistics, or by another vendor is a critical step in the assurance of a well organized study. We perform 100% QC verification on all collection kits produced by us and can accommodate QC checks for kits assembled by another vendor. We utilize QC documents for this procedure and offer these documents to the client in hard copy as well as electronically for their regulatory file.

We are in the process of developing an additional module for Biolistics Online that will enable us to perform the QC function and provide this information electronically through this system so you, as the client, can have the ability to view this information as needed from anywhere you have internet access.

TRAINING AND USE OF KITS

The proper use, storage and disposition of collection kits is critical to the success of your study. The professional team at Boca Biolistics has the capability to train your investigative sites on the storage and use of the collection kits that will be used in the study. We can design custom training documents as well as on-line training sessions for multiple investigative sites or utilize your existing documents and/or other training tools.

Please contact one of our account representatives now to discuss your current or near future needs at sales@bocabio.com or (954) 449‐6126.