Note: This article originally appeared on the Maxiom Group Blog. Permission to reprint has been granted by the author and Maxiom Group.
Many Biotech and pharma companies at various stages of maturity struggle with an accurate tracking mechanism for managing all of their samples. Similar to commercial and clinical inventory (management / tracking / visibility), sample visibility is also a significant issue for Life Science companies. There are several considerations, for example:
- Legal: e.g. when a patient withdraws from a study and wants their specimens withdrawn and/or destroyed.
- Regulatory: such as how long samples are to be kept in storage.
- Logistics: packaging, labeling, and shipping conditions.
- Cost: such as absorbing expensive long-term storage.
Good sample management is essential to maintaining compliance and controlling costs.
Naturally there are many spreadsheets and ad hoc systems being used to manage samples, but we all know these approaches usually don’t provide the level of control and visibility required. There are many software solutions available. There are web-based (on-demand) solutions, Windows-based solutions that can be run on-premise, a variety of Laboratory Information Management Systems (LIMS) which have sample tracking capabilities, several CMOs, CPOs, and CROs that offer their own solutions, and even sample management features and support from ERP vendors.
The sheer number of solutions available can be overwhelming, and there is only one way to get through them: understand the functional and technical requirements. Understanding requirements allows you to eliminate the number of potential solutions and identify the one(s) that best match the needs of your business. Some examples are:
Functional Considerations:
- What type of samples do you need to manage?
- How are they packaged?
- What are the archiving/long-term storage requirements?
- Will you utilize bar codes?
- How many vendors do you use?
- How do you handle sample tracking internally and to what level of detail?
- How do you currently track shipments?
- How much of the distribution process will be handled by partners
- These questions can help you determine which solutions will fulfill your functional requirements.
Technical Considerations:
- What are the capabilities of your company and IT staff?
- What technology resources do you have available?
- What is your budget?
- Do your partners offer a viable solution?
- Will you be using RFID?
These questions can help you determine whether to go with a hosted or on-demand (SaaS) solution running through your browser, or something installed on-premise at your company.
Taking a hard, objective look at your process and requirements, and then using those throughout the software selection process, will help you find the right solution and finally get a handle on all those samples!
