Tailored Bioanalysis Services Solutions
With over 40 years of bioanalytical services expertise, our ability to manage both small-scale studies and large clinical trials have driven successful outcomes for countless partners. Whether you require a seamless multi-phase approach or a collaborative, flexible partnership, our bioanalysis services ensure cost efficiency, eliminate bottlenecks, and provide proven results in in all modalities – no matter how complex they may be. We deliver operational excellence paired with tailored solutions to meet the unique demands of your program – from method development and validation to nonclinical and clinical analysis and support services.
Bioanalytical Strategies Unlocked: Innovative Approaches to PK, Immunogenicity, and Biomarkers
In this webinar, our scientific experts will walk you through real-world case studies that illustrate how innovative bioanalytical approaches can help you overcome common hurdles in pharmacokinetics (PK), immunogenicity, and biomarker applications.
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eGuide: Bioanalysis from Early-Stage to Clinical Drug Development
Accounting for modality complexity, evolving regulatory expectations, and the critical importance of upfront planning, this eGuide explains how to identify risks early and align your bioanalytical strategy with the needs of your compound, your timeline, and your team.
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Frequently Asked Questions (FAQs) About Bioanalytical Services
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Can you assist with both nonclinical and clinical bioanalysis?
Yes, our bioanalytical services span both nonclinical and clinical phases of drug development. We offer method development and validation, as well as comprehensive support for sample collection, logistics, and data management during clinical studies. Our team of experts is equipped to handle the complexities of both stages, ensuring a seamless transition from discovery to clinical validation.
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How do you ensure the accuracy and reliability of your results from bioanalytical services?
We prioritize data integrity and quality assurance by employing strict quality control measures and utilizing state-of-the-art technology in our laboratories. Our standard operating procedures (SOPs) comply with Good Laboratory Practice (GLP) and current regulatory guidelines, ensuring that our bioanalytical solutions are both accurate and reliable for informed decision-making.
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What is the typical timeline for starting a bioanalysis project with your team?
We offer rapid start times for our bioanalytical services, with methodologies optimized to increase efficiency. The exact timeline can vary depending on the specific requirements of your project, but our dedicated team works diligently to meet critical deadlines and ensure timely delivery of results.
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Do you have experience with bioanalytical services for novel drug modalities, such as gene therapies or antibody-drug conjugates?
Yes, we specialize in the bioanalysis of novel drug modalities, including gene therapies, RNA-based therapies, cell-based therapies, and antibody-drug conjugates. Our team is experienced in developing and validating new analytical methods tailored to the unique properties and mechanisms of action of these advanced therapies.
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Do your bioanalysis services help reduce drug development costs?
Our strategic approach minimizes errors and avoids costly repeated work. By providing accurate and reliable bioanalytical data from the outset, we help you make informed decisions and streamline your development process, ultimately reducing the overall costs associated with drug development.