How to choose an independent contract laboratory
Outsourcing laboratories are nothing new. But when you are ready to outsource your project, do you know how to find the best laboratory to meet your needs?
There are many different laboratories to choose from. Some are smaller specialized laboratories that only work with specific instruments and methods, while others have multiple locations focusing on a variety of testing needs and services. Some laboratories work on more of a commodity basis by pumping out large amounts of projects at a reduced price, while others are more investigative and perform each project based on a custom plan for each customer.
Not to say that one or another is necessarily the best, it all depends on the needs of your project. This typically includes your time frame, project scope, and budget which can change the type of testing facility that is right for you. There are some questions though that you may want to get answered before you commit to a laboratory.
What is their organization like?
You can request to see the organizational chart of a lab you are considering. This will give you a good idea of the laboratory’s size and what specialties they focus on. Ask to speak with a scientist as many labs have their scientists available to answer questions. This can be really beneficial as after all they will be the ones that will be working on your project and it’s reassuring to know that they understand the scope of your work and what the key details are that you aim to gain. Also if you have a larger project this will make sure that they have enough staff and instrumentation to be able to handle the needs in your timeframe. Having the organizational chart will show you if they’re more of a sales organization cranking out projects or more of a custom research laboratory.
Also ask what kind of affiliations they have. These will vary depending on what they specialize or focus on, but some important ones to look for are affiliations with the FDA, DEA and cCMP. These certifications show that an outside organization has audited the testing laboratory and given their stamp of approval. Also depending on your project it may be necessary that the laboratory you are looking for has the proper certifications to give you usable data.
What kind of non-disclosure agreement do they have in place and will they use yours if requested? Depending on what you are testing and what level of secrecy you want to maintain this could be a very important question. Make sure you understand who owns the data that is collected from the testing and how it can be used by the lab. Although on the other side of this when asking for testimonials from a laboratory that follows proper protocol don’t be surprised if they give you general case studies instead of exact details.
If you are local to the testing facility you can always ask to stop by for a tour or to meet some of the scientists that will be working on your project. Even though the internet can be a great place for research and referrals, sometimes there’s still nothing better than seeing something in person to really get a good feel for it. Although depending on how specialized your research this may not be easily done.
What is their laboratory staff like?
What kind of experience and projects have the scientists at the lab worked on before? What kind of education and training do they have? Feel free to ask for a background on the staff that will be doing your project to understand where they are coming from and what types of needs the lab will be able to help you with. Also laboratories vary greatly in what is given out after the testing is performed. If you are not experienced reading technical documents and instrument results then being handed the raw data probably will not help you very much. Make sure that they are willing to go through the findings with you and will write up a report based on what kind of information you are looking to gain from the testing in the first place. Ask if their scientists will be available both during and after the testing to answer questions that may come up.
How do they operate?
Standard operating procedures are common at testing laboratories. This is documentation that defines specific steps and policies as to how the laboratory is operated. While you may not have the time or access to go through their entire SOP, review the table of contents and key sections that are important to you. Their SOP will give you a basic understanding of what operating procedures and methods the laboratory has in place. It should also let you know what types of validation steps are used, how records are kept, and how data is collected and reviewed. This may also give you an insight into how questions that you may have in the future will be answered and how the lab will be to work with in the future.
Also the contract lab that you choose should be its own entity and not part of a larger corporation. You want to make sure to pick an independent contract laboratory. Although while you want one that does not have influence from a larger parent company it can be good if the laboratory has relationships with university’s and even other independent laboratories as it will have a larger knowledge base and can increase the scope of projects that it can take on becoming more of a true full services laboratory.
What Laboratory Equipment will be used?
If you are familiar with analytical instruments and tests you may want to ask for an equipment list as if you are not able to go and see the laboratory in person this will be another indicator as to the size of the facility and their capabilities. Also feel free to ask questions to the laboratory about equipment maintenance to get a good feel to how the equipment being used is kept.
Contract Laboratory Experience
Once you find a contract lab, be open with them. They will be bound by confidentiality though an NDA. Let them know what the project will be used for and why you are getting the testing done. This way they can tailor their research to what is important to you and this will result in a better end result. If you are going to a laboratory for R&D but they can also help you with regulatory matters or other services that you may need this will save you time and money by being able to get everything done at one place. So feel free to ask what other services they can do for you.
Also consider what kinds of litigation support services they have available. This is something that can be very important to both show you their range of abilities as well as to reassure you if you ever have a problem and need their help down the line that you will have someone there for you to protect your patients or verify your product.
In short do your research and don’t be afraid to ask questions. Check their response time and helpfulness on your questions. Be sure to know what kind of data and support you are going to receive during and after the testing process. Here is a quick checklist of things you may want to know before you decide on a specific laboratory for your testing needs:
• Is the lab accredited by the FDA, DEA, or any other organization that is necessary for your project?
• Does the lab operate under cGMP?
• What is the background of the scientists that will be working on your project?
• What is the size of the lab/what kind of equipment will they be using?
• What are their Standard Operating Procedures?
• What kind of data will you receive? (raw data or a custom report)
• Are they willing to work with you after the project is completed?
• Can they help you with other services needed which well to save you time and money?
• Do they have litigation experience?