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Test Outsourcing: Picking the Right Partner for You

Outlining the elements of a contract testing partner relationship

Paula McDaniel, PhD

As a research or testing team lab manager, you will encounter both planned and unexpected events that require finding alternatives to using your own staff. Short- and long-term changes in testing volume, staffing shortages, skill gaps, and instrument outage/availability can all precipitate the need to find an outsourcing partner ideal for your needs and budget. Refining the specific support needed, provider option sorting, and partnership management comprise the elements of a successful relationship.

Ideally, plan ahead for the transition to an external partner by addressing issues relating to method transfer, benchmarking, financial considerations, and confidentiality upfront. Start with mapping out the steps in your processes to clarify your gaps and challenges. Do challenges come from planning, methods development, sample preparation, data collection, data analysis, or integrated interpretation? Operations that require limited background details will be easier to address with an external partner. Be realistic about what an outside partner can do without the historical knowledge such as detailed chemistry or process information you have in-house. Expectation mismatching can result in frustration on both sides. Keep work in-house that requires nuanced knowledge that is difficult (or impossible) to transfer without extensive investment in training and knowledge transfer. 

As you dig into the details of where the needs exist, identify individual steps in your process that leverage the flexibility and expertise levels of your partner. This will help you establish a realistic outsourcing budget. Consider the following elements of a contract testing partner relationship:

Routine or non-routine testing – are established standardized methods (such as ASTM or USP) needed or something optimized for your chemistry, sample size, temperature range? Not all testing partners offer methods development/optimization, so ensure this skill is part of your vetting process if needed. 

Analysis and documentation – is a yes/no answer sufficient or do you need formal chemical structural interpretation or advanced reverse engineering skills? Familiarity with your chemistry or industry might be needed if senior scientist level support is your key gap. Partner your test lab with an internal expert such as a formulator. Together they can become a powerful team to interpret test findings.

Quantitative analysis – if you need quantitative testing, ensure you think through detection limits and value uncertainty. These specifics can dramatically influence the method and validation needed to deliver something you will find useful.

Turnaround time – consider timeline to establish/benchmark the testing and ongoing analysis. Help your partner plan by providing insight into your timeline specifics. For example, planned versus unplanned fast turnaround time can sometimes be viewed differently in terms of cost. 

As you dig into the details of where the needs exist, identify individual steps in your process that leverage the flexibility and expertise levels of your partner.

Understand the flexibility of your outsourcing partner - discuss granularity of your need to understand impact on cost and turnaround time. Consider doing things like pre-preparing samples, transferring an in-house method or obtaining data-only results for in-house interpretation. Also, don’t expect methods development and advanced interpretation to cost the same as standardized routine testing. As in your organization, the skill level and brain/instrument time required for the two are quite different.

Consolidation of services – a hidden cost to using an outsourcing partner is the back-office support for service ordering, invoicing, and payment. Understand options such as monthly invoicing and blanket purchase orders to reduce overhead costs. In addition, by consolidating your testing needs with a smaller number of key partners, pricing negotiations can also be an option. Don’t leave this up to your individual scientists as there is often discomfort around discussing price. Management and procurement should take the lead for the most favorable outcome.

Define lab certification requirement – there are many options, and it is important for you to understand how your data will be used. Are you comparing results within a set of samples or do you need a fully validated method with established uncertainties/detection limits for submission to a regulatory body such as FDA. Testing facilities regulatory environments can include basic internal quality systems (university research lab), ISO 17025 (overall formal quality systems including instrument verification, employee training, documentation and fully validated methods per ISO guidelines), GMP/Good Manufacturing Practices (fully validated methods and rigorous systems designed for use in pharmaceutical industry). Are you doing work at discovery phase or do you need release testing? Costs associated with developing and validating a new method for your chemical system should be factored in your budget and timeline. If you expect a discovery-focused method will ultimately need to be validated for release testing, communicate that to your partner early so choices can be made when it comes to instrument/testing class to make the validation phase go more smoothly.

Don't make them guess! Guessing costs time and money.

Once you have decided the scope of support needed and the testing partner, making an investment in sharing methods, chemistry, and project/timing needs will maximize the relationship. By sharing background details, they will be impactful partners in terms of time, cost, and value. Don’t make them guess! Guessing costs time and money. Establish additional confidentiality terms to give you confidence in the security of your information. A partner that treats all customers as if there is a confidentiality agreement in place is the best one for you because their overall systems reflect their respect for your information.

When transferring your protocol, provide instrumental and sample prep conditions. Perform benchmarking to ensure all the bugs are worked out in material prep, data acquisition and analysis procedures. Specify if you want the method improved (detection limits or resolution) or want it run as-is for historical comparative purposes. 

If using a standardized method (such as ASTM) or a partner’s in-house method, confirm it will apply to your system. Is your sample too small or too big? Is your sample too dilute or too concentrated? Is your material sufficiently soluble in the solvents compatible with the method/instrumentation? Are conditions of interest, such as temperature, accessible under the method or instrumentation? Is your material stable in the solvent or environment (inert or air) used in the method? Ensure you and your testing partner have researched these aspects to ensure the existing method will apply. If not, a partner that is facile at developing new or extending methods is needed. 

After clarifying the testing service scope needed, identified an appropriate outsourcing partner and are ready to kick-off the relationship, consider creating a project manager to facilitate the movement of information to and from the testing partner. Depending on the complexity of the work, either involved methods development or large routine testing workflows, establishing a single point of contact can help questions/issues get resolved quickly and avoid misdirection or miscommunication. Having regularly scheduled project milestone meetings with the supplier to obtain status updates or exchange information in terms of workflow or capacity issues will help both parties have a more successful relationship. 

Last, don’t forget the potential internal issues you might encounter relating to accepting a third-party organization. The natural tendency is to be protective and hesitate to use outside services for fear that internal resource job cuts will result. Instead, most companies value an organization that finds a flexible way to meet their internal customer needs. Remember, you don’t want your customers to go around you to engage an external partner because your team couldn’t deliver. Take ownership to explore all options to delight your internal customers<em-dash>a well-thought-out outsourcing strategy is an important tool in your chest to not overlook! 

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