What I Learned About Biospecimen Planning From a Loose Saddle and a Smug Horse
- Elena Sinclair
- May 26
- 6 min read
Updated: Jun 6
My first horse ride went from bad to worse in a snap. It was supposed to be picturesque — think windswept hair, rhythmic hoofbeats, and me, victorious in a black velvet helmet and snazzy Paddock boots. Instead, it was a brief but humbling journey from saddle to sand. One moment I was channeling equestrian elegance; the next, I was splattered on the sand (mercifully, it was sand!), my back refusing to believe the brutality of the fall.
Max - a chestnut thoroughbred with more attitude than sense - trotted over, mane still adorned with the daisies I had lovingly woven in earlier (at least I got the freaking daisies right!), and gave me what I swear was a smug, equine smirk. Meanwhile, the saddle - the one that was supposed to keep me upright - dangled uselessly off his left side like a hippie's handbag.
Now, for those unfamiliar with the fine art of horse saddling, let me enlighten you.
There is an actual sequence: prepare the horse > place the saddle > cinch the front > secure the breast collar > tighten the flank cinch > make final adjustments. Skip a step or fudge the order, and you don’t just make the horse mad — you become airborne or ground-bound.
So, what does this have to do with biospecimen planning?
Nothing. And everything.
Because right after you’ve gone through, what I hope, the careful business of biomarker selection, you hit a phase in the biospecimen lifecycle that many treat with the same casual disregard I gave to saddle straps: biospecimen planning. And just like riding a horse bareback might sound daring until gravity makes its opinion known, skipping or mishandling biospecimen planning can derail even the most promising scientific endeavors.
No one wins the Kentucky Derby bareback. The same goes for clinical research. Saddle up — correctly — or prepare for a fall.
The No-Excuses Guide to Biospecimen Planning
Look, I get it, no one gets into biotech to write blood draw schedules or argue over anticoagulant tubes — but skip those details, and your shiny biomarker strategy can unravel faster than a loose saddle strap. Biospecimen planning isn’t just a line item on your operational checklist. It’s the scaffolding that holds up your entire translational strategy — from patient safety to regulatory credibility to data interpretability.
Here’s the bare minimum playbook for building a biospecimen plan that will give you a foundation to build on. These ten domains should be pressure-tested before your first SIV.
Patient & Clinical-Care Considerations
Blood volume limits & anaemia risk: When working out your study and visit blood volumes think global. Some countries have stricter guidelines on maximum blood volume than the US. Plan accordingly. Consider the health status of your participants. This especially critical in paediatric or frail cohorts.
Physiological limitations: Think before asking for extra 60 mL from your participants. Cachectic, thrombocytopenic or anticoagulated populations may preclude large, invasive or frequent collections; consider microsampling, dried-blood spots or salivafrom someone who’s cachectic or anticoagulated.
Patient-centered logistics: Align visit windows with routine care or enable at-home collections (e.g., capillary blood, self-shipped kits) to reduce travel burden and screen failure [1].
Regulatory, Ethical & Biosafety Frameworks
Export rules & GMO permits: Especially in CGT trials, know which countries require special handling or restrict the storage or export of samples.
Consent & privacy compliance: GDPR and other local laws may limit future use or data linkage — embed flexibility in your ICF design.
Shipping classifications: Infectious and GMO samples require validated IATA packaging. Budget accordingly.
Specimen Strategy & Analytical Fit
Matrix & volume selection: Pick the least invasive option that meets assay needs. Always define backup matrices and collection tubes [2].
Assay context-of-use: Distinguish integral, integrated and exploratory biomarkers to set the correct validation bar and TAT targets [3].
Aliquoting strategy: Plan for retesting, bridging, and multi-year retention windows. This is not the time to “guesstimate.”
Pre-Analytical Variables & Stabilization
Tissue processing times: Think of the most labile molecule you want to study (like RNA) and hedge your bets on this one.
Freeze-thaw cycles: Many biomarkers degrade after two cycles. Use single-thaw workflows or stabilizers whenever possible.
Tube choice matters: Choose tubes with the biggest gain downstream. Standardize it in your lab manual. Check on consistency of supply.
Storage stability: –80°C, usually, is your friend; –20°C is a ticking clock. Define hold times clearly. Check with all the sites AND labs on their cold storage capabilities. Put is in your contract!
Timing, Frequency & Operational Feasibility
PK/PD coordination: Biomarker timepoints must align with drug exposure, not just convenience. Are your participants and sites capable and willing to adhere to your collection requiremens?
Clinic realities: Avoid critical collections on Thursdays & Friday. Learn and memorize the schedule of each site and lab. Build in real-world buffer zones.
Interim triggers: Adaptive trials require real-time processing capacity, or risk stalling key decisions. Check and double-check capabilities of your stackeholders. All of them!
Shipping & Chain-of-Custody
Validated cold chain packaging: Use SOP-qualified shippers, phase-change materials, and data-loggers; recorded temperature excursions demand CAPA and may invalidate results.
End-to-end chain-of-custody: Every hand-off must be traceable — from bedside to destruction. Gaps undermine data integrity and regulatory defence.
Courier reliability: Map holidays, lanes for dry-ice resupply, customs clearance and contingency storage to prevent thaw or formalin over-fixation. Nothing ruins a trial like a thawed sample.
Laboratory Capacity & Turnaround Times
TAT expectations: Biomarker delays can affect clinical decisions. Shortening lab workflows can shave off days, but oftent nearly impossible to change after the contract is signed. Plan alongside your biomarker strategy.
Central vs local testing: Central labs improve consistency but may add transit days; hybrid models or parallel liquid-biopsy testing can hedge risk [4].
Real-time data flow: Direct lab-to-LIMS integrations reduce human error and support adaptive designs.
Risk Mitigation & Contingency Planning
Back-up matrices: Pre-authorize ctDNA or serum fallback options in advance. This prevents protocol amendments. Big time!
QA/QC duplicates: Store extra aliquots at a secondary site for validation or disputes.
Kit and critical reagent supply: Dual-source where possible. Reagent outages have halted more trials than IRBs ever have.
Sustainability, Cost & Environmental Impact
Lean kit design: Smaller tubes and fewer components reduce waste and cost.
Eco-friendly cold chain: Reusable shippers and vacuum panels cut emissions and improve stability.
Biobanking & Future Governance
Long-term storage & audit trails: Use ISBER/NCI guidance to maintain sample integrity over the years.
Rich metadata tagging: SPREC/BRISQ fields enable meaningful future reuse and retrospective analysis. PubMed →
Bottom line: A good biospecimen plan doesn’t just collect samples — it future-proofs your study. Get it right from the start, and you won’t be the team scrambling to fix protocol amendments three months into enrollment.
Behind Every High-Quality Data Set Is a Well-Cinched Biospecimen Plan
Much like saddling a horse, biospecimen planning demands more than enthusiasm and good intentions — it requires a deliberate, well-sequenced approach guided by professionals who understand the terrain.
In equestrian terms, you wouldn’t trust your Derby prep to someone who’s only read the manual on bridles. Yet in clinical trials, it’s all too common to delegate biospecimen logistics to overextended project managers at a CRO, hoping they’ll “figure it out” alongside 20 other protocols.
That’s not just wishful thinking — it’s a risk to data integrity and scientific validity. As emphasized in ICH E6 (R3), trial quality is built into the design and planning phase, not rescued downstream by corrective action.
Biospecimen planning is not a back-office task. It’s a cornerstone of operational excellence, regulatory compliance, and ultimately, the credibility of your science.
Treat it as such.
Choose your experts wisely, cinch every strap, and confidently ride forward.
References:
[1] C. Ellervik and J. Vaught, “Preanalytical variables affecting the integrity of human biospecimens in biobanking,” Clin Chem, vol. 61, no. 7, pp. 914–934, Jul. 2015, doi: 10.1373/clinchem.2014.228783.
[2] “Biospecimen Pre-analytical Variables (BPV) Program | Programs | BBRB.” Accessed: May 26, 2025. [Online]. Available: https://biospecimens.cancer.gov/programs/bpv/default.asp
[3] S. Roy-Chowdhuri et al., “The American Cancer Society National Lung Cancer Roundtable strategic plan: Methods for improving turnaround time of comprehensive biomarker testing in non-small cell lung cancer,” Cancer, vol. 130, no. 24, pp. 4200–4212, Dec. 2024, doi: 10.1002/cncr.34926.
[4] V. D. de Jager et al., “Future perspective for the application of predictive biomarker testing in advanced stage non-small cell lung cancer,” Lancet Reg Health Eur, vol. 38, p. 100839, Mar. 2024, doi: 10.1016/j.lanepe.2024.100839.
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