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Bioanalytical Consulting and Software

BioData Solutions® specializes in providing a full spectrum of preclinical to post-market approval bioanalytical consulting services and automation software offerings to sponsors, Contract Research Organizations, and biotechnology organizations for small molecules, biologics, biomarkers, and cell and gene therapy products.


In today’s drug development environment, bioanalytical and stability challenges can make or break a drug platform. In-depth knowledge across a variety of technologies and methods, the ability to rapidly solve analytical problems to keep your program on track, and compliance with current regulatory guidance and industry best practices, are critical for success. Trust the know-how and guidance of experienced bioanalytical consultants to help navigate pharmaceutical development and the rapidly expanding world of traditional small molecule drugs, therapeutic proteins and cell and gene therapies.

Bioanalysis matters now more than ever. We act as your partner, helping organizations of all sizes select and implement appropriate bioanalytical strategies and assays generating reliable data to support your drug development path, build product development strategy, and ensure important bioanalytical data is accurate and will endure regulatory scrutiny.

Bioanalytical Consulting

BioData Solutions offers expertise and hands-on guidance from preclinical and clinical to post-market approval stages, from strategy to execution, from small molecules to cell and gene therapy and from validation to regulatory oversight.

Our expertise encompasses many disciplines, including but not limited to:
Small molecule, oligonucleotides, ATMPs (Advanced Therapy Medicinal Products) also known as cell and gene therapy products, ADCs (Antibody Drug Conjugates), biomarkers, and biologic drugs.

Our service offerings span over various stages of regulated bioanalysis, including, but not limited to:
Operational program management, preclinical and clinical validation and sample analysis, data analysis and market planning with a strong emphasis on regulatory compliance.

Red Thread® by Ariadne Software®

Ariadne Software®, a brand of BioData Solutions, brings the power of automation to bioanalytical auditing and statistical analysis using the power of advanced computational techniques. With regulatory guidance and industry practices at its heart and information security at its core, Red Thread offers a secure and compliant software that provides significant time-and cost-savings, standardization of your analytical and auditing approaches, and transparency among sponsors and CROs.

Value We Bring to You

Specialized bioanalytical consulting services, tailored to your needs

We can navigate you from molecule to market with our broad spectrum of bioanalytical services for preclinical, clinical and post-marketing for modalities ranging from small molecules and biologics to cell and gene therapy products can take you from molecule to market. We bring different resources with specific expertise to the table at different stages of your program’s lifecycle.

Automation Software: For Bioanalysts, By Bioanalysts

By automating some repetitive everyday processes, Red Thread offers unprecedented efficiencies and unmatched consistency in statistical analysis and auditing of your bioanalytical data. It encourages transparency between sponsors and the CRO and allows the scientists to allocate more time to mission-critical experimental design and troubleshooting.


Our team of industry experienced consultants bring the highest level of experience and knowledge to assist with everything from bench-level tasks to strategic and market planning. You can trust us to be a part or an extension of your team or provide bioanalytical assay management to your team. We can provide as much support as you need.


We strive to meet your critical timelines while achieving time, cost, and resource efficiencies through planning and unique tools, such as Red Thread. Our consulting services and software allow for better allocation of your valuable human resources by letting them focus on the critical issues at hand.


All our activities are integrated with current regulatory guidance and industry best practices at the heart, from planning to execution. Through collaborative management, attention to detail, effective communication and responsiveness, we guide and support your program with precision.

Your success is our success!

Contact us today and let us know what challenges you are facing.