Biospecimen Operations Consulting

Precision operations.
From patient
to data.

Expert guidance in PD and biomarker sample logistics, translational medicine support, and biorepository strategy for pharma and biotech programs.

8+
Years experience
100K+
Samples managed
GCP
Compliant

End-to-end biosample
operations expertise

Specialized consulting across the full biospecimen lifecycle — from protocol design to data delivery.

01
PD & Biomarker Sample Logistics

End-to-end coordination of pharmacodynamics and biomarker sample collection, processing, shipment, and delivery to central labs and third-party analytical vendors.

Sample flowchartsCollection kitsQuery resolution
02
Biorepository Strategy & Buildout

Design and scale biobank operations from the ground up, including inventory systems, LIMS implementation, and SOP development for high-throughput specimen handling.

Biobank designLIMS setupSOP development
03
Vendor & Contract Management

Vendor identification, qualification, contract initiation, and budget management. Ongoing performance tracking and query resolution to keep studies on timeline.

Vendor qualificationSOW reviewBudget tracking
04
Regulatory & GCP Compliance

Ensure biosample operations meet ICF, IRB, GCP, CLIA, and IATA standards. Audit preparation, deviation management, and CAPA implementation.

GCP / CLIAAudit readinessIATA / DOT
05
Laboratory Manual Development

Draft and review lab manuals, collection guides, and requisition forms aligned with study protocols and clinical needs across single and multi-site trials.

Lab manualsRequisition formsProtocol alignment
06
Translational Medicine Support

Bridge scientific and clinical operations by embedding in study teams, establishing analytical workflows, and ensuring biomarker data delivery supports TM program goals.

Study team liaisonData reportingHematology oncology

Biospecimen operations
built on precision.

8+ years managing biosample logistics across oncology clinical trials, federal research, and pharmaceutical programs.

GCP/GLP Certified in Good Clinical Practice, Good Laboratory Practice, CLIA, cGMP, and CAPA across multiple research environments
BSL-3/4 Trained and experienced in high-containment biosafety laboratory operations at federal research institutions
LIMS Implemented and administered Freezerworks, LabVantage, and REDCap across clinical and research biorepository programs
FEDERAL Public Trust cleared; extensive experience managing DoD and federally-funded biospecimen programs at WRAIR and WRNMMC
Osman Humeida
Principal Consultant

I specialize in building and optimizing biosample operations for pharma, biotech, and federal research programs. My background spans hematological oncology trials, BSL-3/4 biorepository management, and multi-site clinical study support — giving me a rare combination of scientific depth and operational precision.

I've managed over 100,000 human samples, led LIMS implementations, and served as the translational medicine voice on clinical study teams. Whether you need to stand up a biobank, fix a broken logistics workflow, or prepare for an audit, I bring hands-on expertise and structured execution.

Hematology Oncology Translational Medicine Pharmacodynamics Biobank Ops Arabic · English

Let's work together

Reach out to discuss your biosample operations needs. I respond within 24 hours.

Email
OsmanHumeida@apexbiosample.com
Phone
(202) 808-4525
Location
Washington, DC Metro Area

"I work with pharmaceutical companies, biotechs, CROs, and federal research institutions to optimize biosample operations at any stage of a clinical program — from protocol design through final data delivery."

Availability
Accepting new projects
Engagement types
Project-based · Retainer · Interim staffing