Services > Medical Imaging

Medical Imaging based surrogate end-points have become essential for clinical trials to provide an insight to drug safety and efficacy much faster than traditional clinical endpoints. Looking at requirement of Central Imaging Review for authenticity and acceptability of clinical study data, Lambda has taken initiative to build robust and 21CRF Part11 compliant Medical Imaging application Platform, sole proprietary of Lambda Therapeutic Research Ltd., with industry experienced team to provide highly cost effective Central Review Services and consultation for our Sponsors.

Lambda, with its new initiative, is well placed to offer full spectrum of Central Review Services for wide range of therapeutic segments (including Oncology, Musculoskeletal, CNS) with full compliance to regulatory requirements. Imaging data safely stored on Lambda servers with automated back-up are easily accessible for sponsor audits and Regulatory inspections.

Services

• Site Identification & Start-up
• Setting up Central Imaging Lab for each project
• Developing Independent Review Charter
• System Configuration as per Protocol and Validation
• Image Receipt and Quality Check
• Central Imaging Assessment
• Review Quality Assurance
• Imaging Data Management
• Imaging Data - Archival & Storage

Lambda Imaging Platform - Paperless, Automated, Sturdy & Smart

• Very robust and flexible at the same time - configurable for individual charter / protocol in very short time
• Complete Audit trail from Image Upload till Data Export
• "Validated" & 21 CFR Part 11 compliant
• No "manual errors" due to automated calculations
• Assessment Criteria specific Logic Checks
• In-built error checks to prevent reviewer mistakes
• iCRF for Oncology, Musculoskeletal, CNS, CVS etc specific assessment criteria
• Customisable RECIST 1.0 & RECIST 1.1 iCRF
• Hybrid (Paper + Electronic) configuration also possible