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Medical Imaging

Medical imaging stands as an indispensable cornerstone in clinical trials, offering a powerful lens into the intricacies of the human body. At Biotrial’s Core Lab, we recognize the paramount importance of medical imaging in advancing scientific understanding, improving patient outcomes, and enhancing the overall efficiency of clinical research.

Biotrial’s extensive expertise in medical imaging is a legacy dating back to 1997, offering clients a comprehensive array of valuable services. From site selection and support services to centralized assessment and quality control of medical images during clinical trials, our Core Lab ensures a tailored and efficient process adapted to the unique needs of each trial and sponsor specifications.

Key Services:

Biotrial’s Core Lab excels in providing precise quantitative and qualitative measures of imaging endpoints. Our robust processes for image collection and analysis guarantee high-quality data, supporting critical clinical endpoints in diverse therapeutic areas.

Our processes for image collection and analysis allow us to provide high-quality data to support key clinical endpoints.

Expertise in Therapeutic Areas:

At Biotrial’s Core Lab, our expertise spans diverse therapeutic areas, supported by cutting-edge imaging modalities. From rigorous evaluations in oncology to tailored solutions for neurology and cardiovascular studies, our dedicated team ensures precise and tailored imaging strategies. Explore advanced modalities such as CT scans, MRIs, PET scans, and more. (Contact us for a detailed understanding of our capabilities and customized solutions.)

Oncology:
- RECIST (i, ir, m, 1.1): Rigorous evaluation based on recognized criteria.
- Lugano, Cheson, RANO: Specialized assessments for lymphomas and neuro-oncology.
Neurology:
- Multiple Sclerosis: Focused imaging strategies for neurological studies.
- Alzheimer’s Disease: Tailored solutions for Alzheimer’s research.
Cardiovascular:
- Comprehensive imaging support for cardiovascular studies.
Musculoskeletal Disorders:
- Specialized imaging approaches for musculoskeletal research.
Gastrointestinal:
- Targeted imaging solutions for gastrointestinal clinical trials.

Advanced Imaging Modalities:

CT Scan:
- High-resolution imaging for detailed anatomical assessment.
X-ray, DSA:
- Radiographic techniques for a wide range of clinical applications.
MRI, fMRI:
- Magnetic resonance imaging for in-depth anatomical and functional analysis.
PET Scan:
- Positron emission tomography for metabolic imaging studies.
SPECT:
- Single-photon emission computed tomography for detailed functional imaging.
Ultrasound:
- Non-invasive imaging for real-time visualization.
Endoscopy:
- Specialized imaging for internal organ examination.

Our non-exhaustive list represents the breadth of our capabilities, but it’s just the beginning. At Biotrial, we understand the dynamic nature of clinical research, and our experts are prepared to customize imaging strategies to address the unique demands of your therapeutic focus.

Quantifiable and Objective Data

Biotrial’s Core Lab recognizes the critical role that medical imaging plays in delivering quantifiable insights, providing a robust foundation for advancing scientific understanding and making informed decisions. Here’s how our expertise aligns with this essential aspect:

Precision in Measurement:

Our advanced imaging technologies ensure accurate and reproducible assessments, setting the stage for reliable data that is crucial for making informed decisions in clinical research.

Objective Evaluation:

Our methodologies are designed to minimize subjectivity, providing a solid foundation for researchers to derive conclusions based on concrete and measurable data points.

Real-Time Tracking

Whether evaluating treatment outcomes or understanding disease progression, our imaging technologies offer a dynamic and continuous monitoring approach, enabling precise and timely interventions.

Comprehensive Disease Assessment:

The precise measurements obtained through our imaging technologies allow for a thorough understanding of the impact of investigational treatments, contributing to the nuanced evaluation of therapeutic efficacy.

Navigating Beyond Subjectivity:

Our commitment to objectivity ensures that the data derived from imaging is consistent, enhancing the reliability and validity of the outcomes in clinical trials.

Advancing with Technological Precision:

Continuous integration of cutting-edge technologies guarantees not only accuracy in measurements but also opens new possibilities for innovation in clinical research.

Advanced Endpoint services

The necessity for establishing an endpoint adjudication organization is meticulously evaluated for each project at Biotrial’s Core Lab. This evaluation is intricately linked to the nature of the endpoint under consideration and aligns with stringent regulatory expectations.

When adjudication becomes imperative, Biotrial excels in seamlessly configuring the required organization. We leverage a dedicated team of experts, deploying the necessary number of readers to meticulously review each image. This process ensures a comprehensive evaluation, with readers offering their conclusions.

To further elevate the quality of our adjudication services, we implement a thorough reconciliation/adjudication step. This step is managed by a senior, designated expert, guaranteeing a meticulous review process. Alternatively, agreements between the initial readers contribute to a collaborative and robust adjudication framework.

Our commitment to precision and compliance ensures that your clinical trial endpoints receive the scrutiny they deserve, contributing to the success and reliability of your research endeavors.

Site Management

At Biotrial’s Core Lab, our Site Management services are designed to ensure seamless and standardized processes for image recording across all trial sites. Our commitment to precision and consistency is evident in the comprehensive suite of services we offer:

Site training :

Expert-led training programs cover crucial aspects of site operations:
Image Acquisition & Transfer Protocol: Ensuring a standardized and efficient approach to capturing and transferring images.
Patient Preparation Procedure: Guiding sites on preparing patients for imaging procedures.
Protocol Requirements: Detailed training on meeting protocol-specific imaging requirements.

Dedicated Support:

Our Site Management services go beyond initial training. We provide ongoing support to ensure the smooth functioning of trial sites:
- Technical Support and Hotline: Immediate assistance for technical queries or challenges.
- Specific User Manuals: Comprehensive manuals for site preparation, image acquisition, and transfer, offering clear guidance throughout the trial.

Quality Assurance

Biotrial’s core lab prioritizes quality assurance to ensure the integrity and reliability of every aspect of our imaging services. Our commitment to quality is evident in our robust quality assurance protocols:

Compliant & Validated Solutions:

Our software validation policy adheres to the stringent standards of 21 CFR Part 11, guaranteeing compliant and validated solutions for every phase of our imaging processes.

Standard Operating Procedures (SOPs):

Each step of our imaging process is meticulously documented in Standard Operating Procedures (SOPs). These comprehensive guidelines ensure consistency, adherence to protocols, and traceability throughout the entire process.

Daily Backups for Imaging Servers:

The integrity of your data is paramount. Our imaging servers undergo daily backups, safeguarding against potential data loss and ensuring continuous access to critical information throughout your clinical trials.

Secure Web Transfer Tools:

We prioritize the security of data transfer. Our secure web transfer tools facilitate seamless and protected site image uploads, adhering to the highest standards of data confidentiality.

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