Medical imaging is a critical component of clinical trials across various therapeutic areas. Accurate and efficient analysis of images is essential for evaluating the efficacy and safety of new treatments. Traditional methods of image analysis were often cumbersome, time-consuming, and prone to errors. Additionally, the need for secure data storage, compliance with regulatory standards, and global accessibility posed significant challenges. DiSoft is a cutting-edge web-based application designed to address the limitations of conventional medical imaging analysis.
Overview
- Lambda Therapeutic Research is a leading CRO with extensive experience in delivering high-quality medical imaging analysis across various therapeutic areas.
- Lambda, in collaboration with Sarjen Systems Pvt. Ltd., has developed DiSoft (Digital Imaging Software), a customized web-based global imaging application. DiSoft enables the secure uploading, analysis, and storage of images for the evaluation of clinical trial endpoints.
- DiSoft goes beyond offering premium image analysis capabilities by providing the flexibility to customize and meet specific client requirements. It ensures secure access from any location worldwide through web-based portals, ensuring convenient and reliable access to stored images for evaluation and analysis purposes.
DiSoft Features
- Compliant with 21 CFR part 11, Protected health information (PHI), GDPR & GxP
- GAMP 5 validated software
- Secure operation, hosting, database storage & backup
- Supports different types of image uploads (CT, PET-CT, MRI, X-Ray, DXA, FA, CFP, OCT) with de-identification of confidential patient information
- Single/Double Quality Checks
- Single/Double Grader review assessment and Adjudicator review where applicable
- Efficacy data export
- Audit trail facility capturing user credentials, changed values, date and time of changes, ensuring data integrity
- Automated alert emails to notify respective stakeholders about various activities.
- Certification of sites within the database based on study-specific requirements
- Customized Edit-checks
Extensive Capabilities
- Oncology with capability of evaluation methods RECIST 1.1 and Cheson 2014,
- Musculoskeletal for evaluation of Dual X-ray Absorptiometry (DXA) (Densitometry and Ancillary data) and X-ray (Genant Semiquantitative (SQ) scoring method)
- Ophthalmology with evaluation of image types of Color Fundus Photograph (CFP), Fluorescein Angiography (FA) and Optical Coherence Tomography (OCT)
- Future expansion planning for iRECIST evaluation method, Gastrointestinal (GI) imaging
Medical Imaging Software Platforms
| DiSoft-C | DiSoft-D | DiSoft-E |
|---|---|---|
| Independent assessment of RECIST 1.1 (solid tumours) & Cheson (Lymphomas)Handles CT, PET-CT and MRI | Independent assessment of Osteoporosis imagingHandles DXA and X-rayWorks with GE enCORE software | Independent assessment of Age-related macular degeneration (ARMD) imagingHandles OCT (Cirrus, Spectralis, Optovue, Topcon), FA, CFPIntegrated with Orion (A manufacturer agnostic OCT software) |
| Conducted studies: 9 | Conducted studies: 2 | Conducted studies: 1 |
Operational Workflow:
Quality Assessment
Review Workflow
DiSoft revolutionizes medical imaging analysis with efficiency, security, and global accessibility. This cutting-edge web-based application streamlines clinical trials, ensuring accuracy and compliance. Embrace DiSoft’s transformative power and elevate your medical imaging analysis to new heights, driving advancements in healthcare and delivering better outcomes for patients worldwide.
