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Medical Imaging CRO
Imaging analysis solutions across diverse therapeutic areas.
At Lambda Therapeutic Research, we provide advanced Medical Imaging Analysis services that ensure precision and reliability in clinical trials. Our team of Board-Certified Radiologists and Imaging Research Associates utilizes cutting-edge technology to deliver accurate, data-driven insights that are essential for successful drug development.
We offer end-to-end support through our Central Imaging Review Platform, backed by a dedicated team of radiologists, medical imaging experts, Independent Reviewers, and experienced medical writers. Backed by decades of CRO experience, Lambda specializes in a wide range of imaging modalities, ensuring quality and accuracy at every stage of your clinical trial.
Lambda specializes in a wide range of imaging modalities used in clinical trials:
Optical Coherence Tomography (OCT)
Fluorescein Angiography (FA)
Fundus Photography (CFP)
Dual-energy X-ray Absorptiometry (DXA)
Computed Tomography (CT)
PET scan (Positron Emission Tomography)
Magnetic Resonance Imaging (MRI)
Sharper Imaging Insights, Accelerated Trials
Providing the finest quality of data for imaging endpoints across a range of therapeutic areas.
5000+ Images Reviewed
In the last 2 years, we conducted 8 studies, encompassing 1000+ patients, showcasing our proficiency in large population-based research.
Therapeutic Expertise
Boost efficiency and optimize outcomes with Lambda, a trusted CRO with extensive expertise across a wide range of therapeutic areas. Our streamlined imaging lab processes, refined through years of collaboration, seamlessly integrate therapeutic imaging into trial designs. Leveraging our experience as a Medical Imaging CRO, we provide global collaboration, training, and resource planning, alongside consulting on imaging biomarker strategies tailored to clinical development plans across diverse therapeutic areas.
Our experts excel in oncology imaging, conducting independent assessments of solid tumors and lymphomas in line with RECIST 1.1 and Cheson criteria. We adeptly handle various modalities including CT, PET-CT, and MRI. Our extensive experience in oncology imaging covers over 20+ studies in Metastatic Breast Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Head & Neck Cancer, Gastric Cancer, and Ovarian Cancer.
At Lambda, we provide comprehensive DXA imaging services, delivering precise assessments crucial for evaluating bone health and musculoskeletal conditions. Our expertise extends to independent evaluations of osteoporosis imaging, utilizing advanced technologies such as DXA and X-ray. Our skilled team of DXA Technologists ensures accurate site qualification and employs advanced DXA data acquisition protocols, covering assessments such as Bone Mineral Density (BMD), Hip, spine, forearm, Trabecular Bone Score (TBS), and Total/Whole Body Composition.
In the realm of ophthalmology imaging, Lambda stands out with expertise in age-related macular degeneration (ARMD) imaging. We perform independent assessments using modalities like OCT (Cirrus, Spectralis, Optovue, Topcon), FA, and CFP. Our integration with Orion ensures seamless analysis and interpretation, enhancing the diagnostic process.
From Logistics to Seamless Analysis: Enhancing Medical Imaging Efficiency with DiSoft
- DiSoft, developed by Lambda in collaboration with Sarjens Systems Pvt. Ltd., is a customizable GAMP 5 validated web-based global imaging application.
- Compliant with 21 CFR part 11, PHI, GDPR & GxP, it securely uploads, analyzes, and stores various image types for clinical trial endpoint evaluation.
- DiSoft features automated alert emails, customized edit-checks, and an audit trail facility to ensure data integrity and provide convenient access to stored images worldwide.
Extensive Capabilities:
(RECIST 1.1 and Cheson 2014 evaluation methods)
Medical Imaging Software Platforms:
- Independent assessment of RECIST 1.1 (solid tumours) & Cheson (Lymphomas)
- Handles CT, PET-CT, and MRI
- Independent assessment of Osteoporosis imaging
- Handles DXA and X-ray
- Works with GE enCORE software
- Independent assessment of Age-related macular degeneration (ARMD) imaging
- Handles OCT (Cirrus, Spectralis, Optovue, Topcon), FA, CFP
- Integrated with Orion (manufacturer agnostic OCT software)
Medical Imaging Services
- Query Management
- Real-time quality check of all received imaging
- Receipt of Medical Imaging, including CT, MRI, PET, and X-rays
- Expert Reads in real time
- Scheduled or as-needed data export capability
- State-of-the-art analysis software with premium analytical tools & features.
- Customized reads and reporting that meet your specific needs and turnaround time
- Site Support & Management
- Effective and timely communication in your preferred format.
- Dedicated personnel for the sponsor communication and vice versa.
- Protocol Development
- DICOM transfer setup
- Grader Selection, training, and approval.
- Imaging Site Qualifications and its approvals
- Preparing Site Operation Manual and Individual site training
- Creation of Imaging Review Charter with the association of the Scientific and Medical Affairs team
- Real-time imaging transfer and receipt using our in-house advanced imaging transmittal software that ensures PHI de-identification
Our Proven Workflow: Optimizing Medical Imaging for Clinical Trials
Lambda’s medical imaging services excel at overcoming imaging challenges in clinical trials, ensuring the efficient and timely delivery of high-quality imaging data through a well-defined workflow.
- Documents Preparation such as IRC, IAG, SOM
- Site Training and Certification
- Image upload with built-in pre-checks
- Pseudo-anonymized images
- Automatic Notification
- QC by trained image research associates
- Images managed by a secure cloud-based system
- Blinded and unbiased image assessment by independent experts.
- Data Export for statistical analysis
Collaborative Clinical Imaging Solutions: Partnering with Sponsors and Investigative Sites for Precise Medical Imaging Trials
At Lambda, we work hand-in-hand with sponsors and investigative sites to ensure accurate imaging throughout the study. Our Medical Imaging team collaborates with scientific and medical services to develop tailored image acquisition guidelines, leveraging the expertise of highly experienced subspecialty reviewers in various radiology fields. This collaborative approach ensures the precise execution of clinical trials, optimizing data quality and outcomes.
Regulatory Compliance
Lambda is well-versed in regulatory guidelines defined by various authorities, including the US FDA’s “Clinical Trial Imaging Endpoint Process Standards.” Backed by years of CRO expertise, Lambda’s medical imaging services ensure compliance with these guidelines, maintaining imaging data quality within and among clinical sites with verifiable records.
Let's Unveil New Therapies Together
Connect with our experts to leverage our proven track record of clinical research excellence.