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GLP Preclinical Sample Analysis: Pioneering Drug Development

In the ever-evolving landscape of drug development, precision and reliability are paramount. At Biotrial, we have honed our expertise to provide cutting-edge GLP Preclinical Sample Analysis services utilizing state-of-the-art mass spectrometry. With over two decades of experience, we’re well-versed in all phases of regulated drug development, ensuring the accuracy of measurements of parent drugs and metabolite concentrations in a diverse array of biological matrices.

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Elevating Drug Development: A Commitment to Safety

Safety is the linchpin of successful drug development, and at Biotrial, we hold it in the highest regard. Our GLP-certified laboratory, operated under rigorous Good Manufacturing Practices (GMP) guidelines, is equipped with the latest technology and staffed by a team of experts. This makes us the vanguard in ensuring the safety and efficacy of the compounds we analyze. Our team conducts preclinical studies that serve as the cornerstone for advancing to clinical trials.

Preclinical Studies: Laying the Foundation

Preclinical research in drug development serves as a vital risk-assessment process designed to understand the impact of a drug on animals and extrapolate potential outcomes in humans. These preclinical studies delve into the toxicological and pharmacological responses of the drug, particularly in relation to dosage, paving the way for the progression of research involving human volunteers.

To ensure regulatory compliance and the smooth continuation of drug studies, it is imperative that the sample collection and testing environment meet stringent standards for facility maintenance, ethical treatment practices, and the administration of safe dosages. The right Contract Research Organization (CRO) not only meets but often exceeds these expectations, facilitating the efficient clearance of this initial stage in drug development. Moreover, the insights garnered from preclinical testing significantly contribute to a streamlined drug development process as it advances.

Tailored Bioanalytical Services

Biotrial supports biotechnology and pharmaceutical industry in their drug development programs by performing high-throughput analysis of samples obtained from preclinical studies through late-phase clinical studies for innovator compounds.

Early-stage clinical samples
- PoC: Proof of Concept
- SAD: Single Ascending Dose
- MAD: Multiple Ascending Dose
DDI: Drug-drug interactions

Food effect
Pharmacokinetics / Toxicokinetics studies
Bioavailability studies
Bioequivalence studies

Timeline

Time is of the essence in drug development, and our commitment to your success includes efficient processes designed to meet tight timelines. We understand the urgency of your work, and we’ve streamlined our operations to deliver results promptly.

For 12 subjects, you can expect QCed data within 5 working days, covering approximately 350-400 samples. With 24 subjects, the timeline extends to 5-10 working days for about 700-800 samples. Our efficiency extends to 36 subjects, delivering QCed data within 10-15 working days for approximately 1000-1200 samples.

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Compliance and Quality Assurance

Regulatory compliance is non-negotiable, and we adhere to the highest standards. Compliant with Good Laboratory Practices (GLP) and FDA guidelines, our commitment to quality spans the entirety of your project. From manufacturing to testing, we ensure that your drug development project aligns seamlessly with regulatory expectations.

Clinical Studies and FDA Compliance

Early-stage clinical studies are pivotal to demonstrating the efficacy of new drugs. Our suite of clinical studies, including Proof of Concept (PoC), Single Ascending Dose (SAD), and Multiple Ascending Dose (MAD) trials, coupled with meticulous evaluations of drug-drug interactions (DDI) and food effects, strictly adhere to FDA guidelines.

Study Support Platform: A Partner in Success

Our comprehensive study support platform includes Watson™ V7.4.2 LIMS (Laboratory Information Management System) software. It enables efficient and high-quality bioanalytical testing throughout the development and clinical phases. Watson LIMS follows your study from initiation to study closeout, ensuring compliance with regulatory requirements, including GLP, 21 CFR Part 11. Our experienced data management and analysis team will assist you at every phase of your project.

Diverse Biological Matrices and Tissues

Accurate quantification of drugs from a vast array of biological matrices and tissues, including matrices with Risk Group 2 pathogens (containment Level 2 purpose-built Laboratory).

Common human matrices: Blood, plasma, serum, urine, feces
Explicit human matrices: Cerebrospinal Fluid (CSF), pleural effusion, aqueous humor
Animal matrices: mouse, rabbit, rat, dog, non-human primate, minipig, etc.

Animal tissue

Heart tissue
Kidney tissue
Liver tissue
Lung tissue
Skin tissue
Spleen tissue
Brain tissue

Your Trusted Partner

At Biotrial, we embrace a practical and results-driven approach to preclinical research, effectively mitigating the risks associated with your drug development program. Our team of experienced and highly skilled professionals is dedicated to helping sponsors meet their research needs while significantly reducing the time required to advance to the clinical phase. Our comprehensive preclinical research services encompass a wide range of critical areas, including biomarker testing, bioanalysis, method development, validation, and transfer, among others.

Expert Resources and 30+ Years of Experience

Our access to expert resources and over three decades of industry experience equips us to deliver exceptional in vitro, in vivo, and bioanalytical testing services to our clients. Regardless of the current phase of your drug product, Biotrial is prepared to assist you in navigating the complex landscape of testing requirements and regulatory obstacles. We understand that introducing life-changing drug products to the market holds the potential to enhance the lives of countless patients, and we are fully committed to helping expedite the journey of your drugs to market. With Biotrial, you have a trusted partner dedicated to the success of your drug development program, offering nimble and high-quality preclinical study services tailored to the unique needs of the biotechnology and pharmaceutical industry.

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