Sharper Insights, Empowering Success in Trials: Medical Imaging Services

Medical Imaging Services: Lambda Therapeutic Research is a leading CRO with vast experience in providing a complete range of medical imaging capabilities and providing finest quality of data for the imaging endpoints across a range of therapeutic areas.

Lambda specializes in training and certification for a wide range of imaging modalities used in clinical trials, including Optical Coherence Tomography (OCT), Fluorescein Angiography (FA), Fundus Photography (CFP), Dual-energy X-ray Absorptiometry (DXA), Computed Tomography (CT), PET scan (Positron Emission Tomography) and Magnetic Resonance Imaging (MRI).

Therapeutic Areas

Oncology Imaging

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.

Musculoskeletal & DXA Imaging

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.

Ophthalmology Imaging

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.

Overcoming Imaging Challenges in Clinical Trials

Medical imaging plays a crucial role in clinical trials for evaluating the efficacy and safety of new treatments. However, new sites with little or no prior experience of working on studies involving imaging endpoints face numerous difficulties which can affect the study outcomes and timelines.

Key Challenges Faced by New Sites in Medical Imaging:Measures taken by Lambda for the resolution of challenges:Key outcomes:
• Improper understanding of protocol and imaging guidelines by the site team lead to multiple errors in image capture and upload of data.
• Poor quality of images received from the site created difficulties in the evaluation of images.
• Multiple missing images affected the grading activity.
• Delay in image upload subsequently delayed the study timeline.
• Incorrect visits being uploaded or missed visits had an adverse impact on the study endpoint evaluation.
Robust Training Sessions: Equipping site teams with in-depth knowledge of imaging requirements, methodology, software, and equipment, ensuring accurate and timely data submission.
Streamlined Communication: Directly addressing site queries via email and follow-up phone calls to bridge communication gaps.
Proactive Follow-ups: Regularly rectifying and resolving imaging protocol queries to enhance study-related imaging efficiency and accuracy.
Unified Understanding: Conducting investigator meetings for a understanding of protocols, guidelines, and regulations, improving overall clinical trial execution.
• Successfully overcoming the challenges by judiciously working with sites to address day-to-day operational challenges, resulting in excellent recruitment without compromising the quality of images.
• 300+ sites participated in various imaging studies globally.
• Consistent implementation of imaging requirements across sites.
• Reduced image rejection rate.
• Uniform data according to the quality control process.
• Improved consistency in evaluation of imaging endpoints.

Our Proven Workflow: Optimizing Medical Imaging for Clinical Trials

Lambda’s medical imaging services ensure efficient and timely delivery of high-quality imaging data for clinical trials through a well-defined workflow.

Study initiation

• Documents preparation  such as IRC, IAG, SOM
• Site training and  Certification

Image upload

• Image upload with build in pre-cecks
• Anonymized images
• Automatic notification

Quality Check of images

Quality check by trained image research associate and images are managed by the cloud based inhouse system

Grader review

Highly qualified and experienced blinded independent  grader review of the images

Data Export & Data Management 

• Data export for statistical analysis
• Data presentation to sponsors

Regulatory Compliance

Lambda is well-versed in regulatory guidelines defined by various authorities, including the US FDA’s “Clinical Trial Imaging Endpoint Process Standards.” Lambda’s medical imaging services ensure compliance with these guidelines, maintaining imaging data quality within and among clinical sites with verifiable records.