Every testing engagement begins before a sample reaches the bench. Documentation, chain of custody, and scope confirmation make up the pre-analytical laboratory testing process. How well this phase runs sets the pace for everything that follows.
Sponsors evaluating a new lab relationship tend to focus on method capability and turnaround speed. The steps between signing on and receiving a first report deserve equal attention. Gaps in sample information or unclear scope are the most common source of early delays.
This walkthrough covers what typically happens during the pre-analytical laboratory testing process:
- What information a lab needs upfront
- How submission forms and sample requirements vary by test type
- How a project point of contact gets assigned
- What a realistic first-weeks timeline looks like
Key Takeaways
- Documentation precedes testing — Sample identity, intended use, and regulatory context need confirmation before analytical work starts.
- Submission requirements vary by discipline — Chemistry, microbiology, and stability samples each carry different handling and paperwork needs.
- A single point of contact reduces friction — Project managers coordinate scheduling, scope questions, and reporting from kickoff onward.
- Kickoff calls set scope and expectations — Method, specifications, and reporting format get confirmed before samples arrive.
- Turnaround estimates depend on test complexity — Compendial testing and custom method development follow different timelines.
What the Pre-Analytical Laboratory Testing Process Covers
The pre-analytical laboratory testing process covers everything that happens between selecting a testing partner and the start of actual analysis:
- Sample documentation
- Chain of custody
- Packaging and shipping requirements
- Confirmation of the test methods and specifications that will apply
Laboratories that manage this phase carefully catch discrepancies early, before they affect a reporting deadline.
For sponsors comparing outsourcing lab services, this phase is also where the practical differences between providers become clear. A lab’s analytical testing capabilities matter. So does how efficiently a team can move a project from intake to an active testing schedule.
Documentation Needed to Start the Pre-Analytical Laboratory Testing Process
Most contract lab services request a consistent set of information before samples ship:
- Product identity, lot number, and formulation or matrix details
- The specific tests or panels requested, referencing method numbers where applicable
- Regulatory context, such as whether results support an IND, NDA, or routine release testing
- Storage and stability conditions the sample requires in transit
- Any existing validated methods or specifications that should be applied
Gaps in this information are the most frequent cause of delayed project starts. A sample that arrives without a clear test request often sits until the submitting lab clarifies scope. A complete submission form avoids that delay entirely.
Submission Forms and Chain of Custody
Submission forms differ by test category. Each discipline tracks different variables, from bioburden risk to temperature excursions during shipping:
- Chemistry submissions require product and method documentation specific to the assay requested.
- Microbiology testing submissions often need additional detail on sample handling history to support sterility or bioburden results.
- Raw material testing submissions typically call for certificates of analysis or supplier documentation alongside the physical sample.
Chain of custody documentation matters throughout. Regulatory submissions depend on a traceable record of how a sample moved from the sponsor to the lab and through testing.
Assigning a Project Point of Contact
Once documentation clears review, most analytical lab services assign a dedicated project manager or scientist as the primary contact for the engagement. This person typically handles:
- Scheduling across the testing timeline
- Scope questions as testing proceeds
- Communication between the lab’s technical staff and the sponsor’s team
- Status updates on project progress
A named contact reduces the back-and-forth that comes with routing questions through a general inbox or call center. For teams tracking multiple concurrent testing programs across different labs, a consistent point of contact simplifies status tracking considerably.
Project Kickoff and Scope Confirmation
Before testing begins, a kickoff conversation confirms the details that shape the entire engagement:
- Which methods apply, and whether any require development or validation before testing starts
- Specifications and acceptance criteria for each test
- Reporting format and the level of documentation required for regulatory submissions
- Expected sample volume and whether the project is a one-time submission or part of an ongoing program
Method-related questions surface most often at this stage. Scoping method development and validation work during kickoff, rather than discovering the need partway through a project, keeps the timeline intact.
What to Expect in the First Weeks
Turnaround timelines for pharmaceutical testing services depend heavily on the complexity of the work.
Compendial testing against an established USP or EP monograph tends to move on a predictable schedule once samples arrive complete. Custom method development, biologics characterization, and nitrosamine risk assessments involve additional steps, including method qualification, that extend the timeline before results are available.
Factors That Affect Turnaround
- Completeness of the initial submission and supporting documentation
- Whether existing validated methods apply or new development work is required
- Sample volume and whether multiple test panels run in parallel or sequentially
- Instrument availability, particularly for specialized platforms like ICP-MS or LC-MS/MS
- Complexity of the reporting package required for the intended regulatory submission
Sponsors who confirm these factors during kickoff generally get a more accurate first-project timeline. A general estimate provided before scope is finalized carries more uncertainty.
Preparing for a Well-Documented Start
A few practices help new sponsors move through onboarding without unnecessary delays:
- Confirm sample requirements before shipping. Contact the lab to verify quantity, container type, and shipping conditions for each test requested.
- Provide complete documentation upfront. Include lot numbers, specifications, and any existing method references with the initial submission.
- Clarify the regulatory context early. Testing that supports an IND or NDA filing may carry different documentation requirements than routine QC testing.
- Ask about the reporting timeline during kickoff. A specific estimate tied to the confirmed scope is more useful than a general range.
Labs with shipping locations across multiple regions, such as facilities in New Hampshire, Massachusetts, and North Carolina, can also reduce transit time and cost for sponsors located near one of those sites.
Frequently Asked Questions About Sample Submission and Onboarding
What information is required to submit a sample for testing?
Most submissions require product identity, lot number, the specific tests requested, and relevant regulatory context. Storage conditions and any existing validated methods should also be included to avoid delays.
How is a point of contact assigned for a new project?
A project manager or lead scientist is typically assigned once documentation clears initial review, before testing begins. This person remains the primary contact for scheduling, scope questions, and status updates throughout the project.
What does the onboarding process typically involve after selecting a lab?
Onboarding generally includes documentation review, a kickoff call to confirm methods and specifications, and coordination of sample shipping logistics. From there, the project moves into active testing according to the confirmed scope.
How long does it take to receive a turnaround estimate after submission?
A general estimate is often available shortly after documentation review, with a firmer timeline confirmed during kickoff once scope and method requirements are finalized. Complex or custom testing typically requires more detailed scoping before an estimate is set.
Are sample submission forms different for chemistry, microbiology, and stability testing?
Yes, each discipline tracks different variables, so submission forms request different details. Microbiology and stability samples, for example, often require additional information on handling history and storage conditions that chemistry submissions do not.
Start a New Testing Project
BA Sciences assigns a dedicated project manager to every new engagement, guiding sponsors through documentation, sample submission, and kickoff so testing begins on schedule. Request a quote to discuss sample requirements and timeline for an upcoming project.
Read More:
How to Develop a Great Working Relationship With Your CRO
5 Considerations When Choosing an Analytical Testing Lab
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