Bioanalysis Services
With over 35 years of experience in the industry, Biotrial offers a wide range of high-quality services designed to support your drug development studies. Our expert team is dedicated to providing innovative solutions, utilizing cutting-edge bioanalytical methods, and ensuring the highest quality throughout the entire process.
Bioanalytical Services Excellence
At Biotrial, we are committed to delivering bioanalytical services of the highest quality. Our dedicated team of experts specializes in bioanalysis, method development, and clinical research, making us a top choice in the industry. We understand the critical role that bioanalysis plays in the drug development process, and our services are tailored to support your unique needs.
Our comprehensive suite of bioanalytical services includes:
- Assay Development: We excel in crafting sensitive and selective assays to ensure the utmost accuracy and reliability of your data.
- Method Validation: Our commitment to quality is reflected in the rigorous validation processes we employ, aligning with the most current regulatory guidance.
- Clinical Sample Analysis: We have the advanced technology and state-of-the-art equipment required to perform precise clinical sample analysis.
Biotrial is equipped with the latest in bioanalytical equipment and instrumentation, which includes:
- LC/MS/MS instruments like the API 4000 and AB Sciex QTRAP®6500, ensure the precision and accuracy of your data.
- Shimadzu HPLC Systems: Our SIL-20AC HT Autosampler, LC-20AD Pumps, and CTO-20A Column Ovens contribute to the efficiency and reliability of our services.
- Temperature-Controlled Storage Facilities: We maintain a walk-in -20˚C freezer with a capacity of 163 m3 (5,760 ft3), as well as 17 -70˚C freezer units to ensure the integrity of your samples.
- Monthly Capacity: With a monthly capacity of approximately 10,000 samples, we have the resources and capabilities to meet your needs efficiently.
- 24-Hour Temperature Monitoring: Our computerized monitoring system ensures that your samples are stored under optimal conditions.
Expert Knowledge & Regulated Bioanalysis
As a leading Contract Research Organization (CRO), Biotrial’s Bioanalytical Services (BBS) team has a profound understanding of regulatory bioanalysis. We offer a wide range of services that encompass method development, validation, and transfer, as well as bioequivalence and bioavailability studies. Our expertise extends to first-to-file (FTF) studies, ADME/TK/PK/PD/DDI analysis, and clinical and preclinical sample bioanalysis. We also provide therapeutic drug monitoring (TDM) services to track drug levels in patients, ensuring optimal efficacy and safety.
Biotrial’s BBS team adheres to rigorous Standard Operating Procedures (SOPs) that align with Good Laboratory Practice (GLP) and with the most up-to-date regulatory bioanalysis guidance provided by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). This approach ensures that the data we generate is not only accurate and reliable but also meets the highest standards for regulatory submission.
A Dedicated Team for Your Success
Biotrial’s BBS team consists of experienced scientists who work in close collaboration with our Research and Development (R&D) department. This synergy enables us to craft precise and sensitive assays that meet the unique objectives required at each stage of drug development.
We understand the importance of innovation in the fast-paced world of drug development. Our commitment to pushing the boundaries of bioanalytical services and providing routine support for innovative drug development with a particular focus on challenging assays sets us apart as your ideal partner.
In an industry where time is of the essence, we are committed to delivering results promptly. Our team, comprising scientists, project managers, laboratory specialists, and instrumentation experts, works diligently to meet your timelines. We are renowned for our industry-leading turnaround times, including first-to-file studies, all while upholding the highest standards of quality.
Added values
Expertise
Specialized in developing selective and sensitive assays and meeting objectives required at each stage of drug development.
Innovation
Routine support of innovator drug development with challenging assays, achievable owing to experience and capability.
Speed and Precision
Our scientists, project managers, laboratory specialists, and instrumentation specialists are committed to delivering reliable results on time.
Cutting-Edge Technology
Our state-of-the-art equipment and instrumentation guarantee the precision and efficiency of our services.
Biotrial is here to support you at every stage of your drug development journey. Our team of experts is ready to assist you with bioanalytical services, method development, and regulatory support. Partner with us and experience the Biotrial difference in the world of bioanalysis and drug development.