Early engagement that protects your timeline
- Laboratory strategy integrated into your protocol from the outset
- Early alignment between diagnostic testing and clinical end points
- Proactive identification of challenges before they become study delays
Build a Stronger Protocol from the Start
Align diagnostic testing with clinical end points, avoid costly amendments, and keep your trial on track from day one with the right laboratory partner.
As clinical trial protocols continue to evolve in complexity, early laboratory planning has become a powerful advantage.
When the laboratory component is thoughtfully designed from the start, studies are better positioned to run efficiently, predictably, and with confidence.
Developing the right treatment for the right patient at the right time demands more than scientific expertise. It requires integrated clinical laboratory and diagnostic solutions, applied early and aligned precisely to your protocol’s clinical end points.
We work with sponsors and clinical teams at the earliest stages of protocol development to ensure your laboratory and diagnostic strategy is built in, not bolted on.
Our scientists engage directly with your team to assess requirements, identify the right biomarkers and assays, and generate early insights that strengthen your protocol and protect your study milestones.
From preclinical feasibility through to commercialization, we provide the full-spectrum laboratory support needed to keep your program moving with confidence.
Why choose us for protocol development?
Scientist-to-scientist collaboration
- Direct communication between our scientists and your team
- Specialty lab project managers for specialty and translational programs
- Therapeutic area expertise applied to every recommendation
Integrated laboratory capabilities
- One partner for biospecimen, assay, biomarker, and central laboratory services
- Integrated solutions to streamline oversight and maintain consistent data
- Support from pre-clinical through to commercialization
Global reach with local expertise
- Global laboratory footprint linked with expert logistics support
- Experience across IVDR, FDA, and other local and international regulatory frameworks
- Quality systems and documentation structured to support timely regulatory submissions and commercialization
- Investigator support to ensure seamless protocol implementation
Supporting your protocol from design to execution
Effective protocol development requires laboratory expertise that spans strategy, assay science, biomarker testing, and operational delivery. We bring all these elements together in a single, integrated partnership, so your protocol is built on a foundation of scientific rigor and practical feasibility from day one.
Assay development and technology transfer
Selecting and developing the right assays for your protocol is one of the most critical decisions in clinical trial design. We work with you to evaluate existing assays, develop new ones where needed, and validate them to the standards your protocol and regulatory strategy demand.
Our assay development capabilities include:
- Development of fit-for-purpose assays aligned to your specific clinical end points
- Method validation and transfer to support multi-site and global trials
- Assay development, including custom panel design dedicated to your trial’s objectives
- Technology transfer from sponsor or third-party platforms into our laboratory network
- Assay bridging studies to support protocol amendments or site changes
Biomarker strategy
Your protocol is strongest when you choose biomarkers that truly support your clinical endpoints, backed by validated assays and the laboratory infrastructure required for reliable measurement. Our scientists engage early to help you build a strategy that is scientifically sound, operationally deliverable, and aligned with regulatory expectations.
Our biomarker capabilities include:
- Biomarker strategy consultation to support endpoint selection and protocol design
- Specialty testing across genomics, immunoassay, flow cytometry, and tissue-based analyses
- Companion diagnostic support and exploratory biomarker testing
- Biomarker validation in accordance with applicable regulatory guidance
- Integrated biomarker data management and reporting to support decision-making throughout your trial
Biospecimen procurement
Robust assay development and validation are only possible with access to the right patient samples, sufficient in number, well annotated, and collected under controlled, predefined conditions. Our biospecimen procurement service supports protocol development by providing access to disease-state and control samples across a wide range of therapeutic areas.
Our biospecimen support for protocol development includes:
- Access to banked and prospectively collected samples to support assay development and validation
- Samples available across a wide range of matrices: blood and blood derivatives, biofluids, tissue, and more
- Clinically annotated specimens reviewed by qualified pathologists
- Feasibility assessment to confirm availability of specific sample types before study design is finalized
- Custom prospective collection for samples not available in our biorepository
Central laboratory support
A protocol is only as strong as its ability to be executed consistently across sites. We provide full central laboratory services and dedicated investigator support to ensure your testing requirements are implemented correctly from site activation through to study close.
Our central laboratory and site support includes:
- Full central laboratory testing capabilities for safety, efficacy, and specialty biomarker assessments
- Investigator support, including laboratory manual development and site training
- Specialist diagnostic kit design and distribution through our logistics network
- Scientific project management ensuring ongoing oversight and communication throughout the trial
- Support across all trial phases, from phase I first-in-human studies through to phase III registrational trials and post-approval
Global labs and Centers of Excellence
Effective protocol development requires a laboratory partner with the reach to support your trial wherever it runs.
Our global network of laboratories and Centers of Excellence spans five continents, providing consistent quality frameworks, local scientific expertise, and the logistical infrastructure to keep your study on track across every site.
Technologies used in protocol development
Protocol development draws on the full breadth of our laboratory capabilities, from flow cytometry and genomics to immunoassay, tissue analysis, and beyond.
Explore our complete range of technologies to see how we can support your specific study requirements.
Related services
Assay development and technology transfer
Work with our team of dedicated scientists for assay development that meets your research, clinical, or commercial objectives, from initial feasibility through to validated, trial-ready methods.
Flow cytometry
We offer tailor-made flow cytometry assay development dedicated to the objectives of your clinical trial, including custom panel design and validation across our harmonized global laboratory network.
Biospecimens
Access high-quality, clinically annotated biospecimens to support assay development and validation, with retrospective and prospective collection options spanning 15+ therapeutic areas.
Project management and scientific oversight
Our scientific project managers provide dedicated oversight across every stage of your clinical program, ensuring timelines, quality standards, and sponsor requirements are met throughout.
Immunohistochemistry (IHC)
Work with our expert IHC team for custom assay development, fit-for-purpose validation, and biomarker expression analysis across a harmonized global laboratory network.
Genomics
Draw on over 30 years of genomics expertise, with NGS, qPCR, ddPCR, and custom assay solutions supporting oncology, infectious diseases, liquid biopsies, and beyond.
Protocol development insights
Protocol Design: How Custom Assays and Biobanking Drive Better Clinical Outcomes
Find out how custom assay development, global biobanking, and harmonized workflows combine to strengthen protocol design and accelerate clinical decision-making.
Development and Validation of Flow Cytometry Assays for CAR-T Cell Therapy
See how Cerba Research developed and validated customized flow cytometry panels to monitor autologous and allogeneic CAR T cells across global clinical programs.
Multiplex IHC for Immuno-oncology: Characterizing the Tumor Microenvironment
Learn how five multiplex IHC panels were developed and validated to profile immune cell populations, functional states, and tumor-immune interactions across solid tumor types.
Global PBMC Processing
Discover how Cerba Research supports PBMC studies worldwide, with harmonized processing protocols, end-to-end logistics, and bespoke solutions across a global laboratory network.
