Services
what sets us apart
Shaping the Future of Healthcare
- Laparoscopy
- Endoscopy
- Critical Care Anesthesia
- Fluoroscopy
- Hematology
- Transesophageal Echocardiogram
- Ultrasound
- Intravenous Ultrasound (IVUS)
- Comprehensive Surgical Instrumentation
- Hi-frequency data acquisition
- Sterile and procedural operating theaters
As a Contract Research Organization (CRO), we conduct both Good Laboratory Practice (GLP) and non-GLP pre-clinical medical device testing. Our dedicated team of experts follows GLP guidelines to ensure rigorous evaluation of device efficacy, safety, and usability in controlled laboratory settings. Adhering to industry standards and regulatory requirements, we provide accurate and reliable data to our clients for informed decision-making. Additionally, we offer non-GLP testing services, catering to specific research needs and exploratory studies. With our comprehensive pre-clinical testing capabilities, we empower our clients to advance their medical devices confidently and efficiently.
We specialize in developing novel research models for pre-clinical studies with various medical devices. Our comprehensive frameworks enable thorough evaluations of safety, efficacy, and usability, helping manufacturers make informed design decisions. With advanced methodologies and regulatory expertise, we accelerate the development of innovative medical technologies that enhance patient outcomes.
As a contract research organization (CRO), we specialize in developing and consulting on pre-clinical research protocols. Our experienced team collaborates closely with clients to design tailored protocols that align with their specific objectives. We provide guidance on regulatory compliance and ethical considerations, ensuring the smooth progression of pre-clinical studies. By leveraging our expertise, clients can confidently advance their research, optimize study design, and achieve successful outcomes.
We place a strong emphasis on data integrity and quality assurance in our comprehensive data analysis services. Our experienced team diligently scrutinizes your pre-clinical data, using rigorous analytical techniques to uncover invaluable insights. With our unwavering commitment to maintaining the highest standards of data integrity, we ensure accurate and reliable results. Through our robust quality assurance measures, we provide you with trustworthy and actionable data analysis, empowering you to make informed decisions, optimize study design, and navigate the path to regulatory approval.
We offer comprehensive project management services to ensure smooth execution of every project phase. Our team coordinates timelines, resources, and compliance with regulatory requirements. We facilitate collaboration among scientists, engineers, technicians, and quality assurance personnel to achieve project milestones efficiently. Our expertise in planning, risk assessment, and problem-solving ensures successful delivery of pre-clinical medical device projects, enabling clients to advance their innovations effectively.
Specializing in pre-clinical medical device testing, we place paramount importance on adhering to Good Laboratory Practice (GLP). GLP ensures that our laboratory operations adhere to rigorous standards, promoting the reliability, integrity, and reproducibility of our research. We meticulously follow established protocols and procedures while handling and analyzing samples, maintaining accurate documentation, and implementing stringent quality control measures. Adhering to GLP principles allows us to consistently produce valid and reliable data, ensuring the safety and efficacy of medical devices, while also complying with regulatory requirements. Our commitment to GLP ensures the trust and confidence of our clients and facilitates the translation of our research findings into meaningful clinical applications.
As specialists in pre-clinical medical device research and development, our interface with the Food and Drug Administration (FDA) plays a crucial role in ensuring regulatory compliance and facilitating the approval process. We engage with the FDA throughout various stages, including the initial submission of investigational device exemptions (IDEs), pre-submission meetings, and the review process. Our dedicated team works closely with FDA representatives to address any questions, provide necessary data and documentation, and adhere to regulatory guidelines. Regular communication and collaboration with the FDA are vital for us to navigate the regulatory landscape effectively, maintain transparency, and achieve successful outcomes for our clients in bringing innovative medical devices to market.
Quality assurance is of utmost importance. GLP-compliant quality assurance involves the implementation of systematic and robust measures to ensure the reliability, integrity, and regulatory compliance of data generated during the research process. It encompasses stringent quality control procedures, adherence to GLP guidelines and standards, meticulous documentation practices, and the utilization of validated testing methodologies. By maintaining strict adherence to GLP principles, we provide trustworthy and accurate data, mitigate risks, ensure regulatory compliance, and contribute to the development of safe and effective medical devices that meet the highest quality standards.
As the field of biomedical research becomes increasingly complex and multidisciplinary, Benchmark Biotech understands the significance of forging strategic alliances with various stakeholders. These partnerships allow us to leverage expertise, resources, and technologies beyond our own capabilities, enabling us to offer comprehensive and cutting-edge solutions to our clients. By collaborating with private industry, academic institutions, regulatory bodies, and other industry players, Benchmark can access a diverse range of perspectives, knowledge, and data, leading to more robust study designs, efficient execution, and accurate interpretation of results. Moreover, such collaborations foster innovation and facilitate the translation of scientific discoveries into tangible clinical applications, ultimately advancing the development of safe and effective therapeutic interventions.
