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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.

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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.

Expertise

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.

Efficiency

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.

Precision

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!

Testimonials

  • I utilized bioanalytical services for biologic therapeutics that included PK assays and immunogenicity assays for clinical stage programs.  Folks from the BioData team covered all aspects of the bioanalytical work including the strategy for the assays, vendor selection and management, assay development and validation and review of data for ongoing studies. They were always a strong advocate on our behalf, established great working relationships with key stakeholders, paid close attention to details, and were diligent about following up on key issues.

    Chief Development Officer at a biotech company

  • BioData Solutions have been a pleasure to work with. The broad expertise in bioanalytical PK/immunogenicity assay development has been instrumental to the execution of our bioanalytical assay development endeavors to support our clinical development programs. Stephanie maintains a high degree of professionalism and efficiency in her work while being fully vested in our projects. She continues to be a valuable resource to our organization.

    Biotechnology company developing therapeutics in oncology

  • I’ve been working with Red Thread for about a year now and their cut point tool is incredibly easy and intuitive to use; no Stats degree required! As a CRO, calculating immunogenicity cut points require some flexibility to match client specific requests or adjustments based on the data. Red Thread quickly added key variables allowing us to use the software for most of our clients.  Additionally, Red Thread, in combination with Watson LIMS, cut down on the duration to complete ADA validations by about one month.  Draft statistical reports are now generated within 24 hours!

    Robert Kernstock, PhD, MBA, Director at ICON Bioanalytical Laboratories

  • Stephanie has been an invaluable resource to us as a consultant in helping with the development and oversight of bioanalytical assays. As a small company, we do not have an in-house bioanalytical expert to oversee and manage our bioanalytical activities at a CRO. Her background in assay development and validation as well as prior experience as a scientific leader at a CRO has been a great asset that has helped us develop and validate assays in a timely manner. She is very thorough and methodical in her approach and excellent at meeting timelines. Her performance as a consultant has exceeded all our expectations and look forward to using her as a consultant on all future programs at our company.

    Gurudatt Chandorkar, PhD, 
Director at Clinical Pharmacology 
Akebia Therapeutics

  • I have worked with BioData Solutions in support of one of my clients. Stephanie has been a great help and has really partnered with our client and myself. While reviewing results we had noticed some issues in the bioanalytical areas for a particular program that I was providing Toxicology support. We asked Stephanie to look into some of the inconsistencies that were noted. She was able to quickly define the specific issues, interface with the lab, the client and myself to provide guidance on how to work to resolve the concerns. Stephanie demonstrated her technical background, her ability to communicate the issues in a way that were understandable to non-specialist in the area and was very professional in her approach. I would recommend Stephanie and hope I get to work with her again on future projects.

    Neal Sharpe, Ph.D., 
Principal at NA Sharpe Pharma LLC

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

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