Overview
Lambda is capable of handling accurate, accessible and reproducible high-quality data through state-of-the-art technologies compliant with regulatory requirements. Lambda's Biometric services are anchored by BizNet® – Excellent regulatory compliant eCRF/EDC platform for paperless and efficient execution of projects and a highly skilled team of data managers, biostatisticians, statistical programmers. It also possesses CDISC (SDTM) datasets deliverables for submissions to regulatory markets such as USFDA.
Study Team for Biometrics
- Timelines Setup
- Study-related DM docs
- KoM / IM
- SAP preparation
- Protocol Training
- Site/User Creation
- Database setup
- eCRF training to the monitors/site personnel
- Data Validation
- Periodic Updates
- Data Validation
- Resolution of queries
- DCF/PD/NTF
- IT support on eCRF
- Data Status Tracking
- SAS Programming
- QA Audit of data
- QA Audit of data
- PI Authentication
- Final TL Production
- Database lock
- QA audit of the report
- Site closeouts
- Discussion with the sponsor on report
Clinical Data Management Task
- Electronic Case Report Form (eCRF): To collect the data as per protocol requirements
- eCRF Completion Guideline (eCCG): Data entry instruction. General and project specific
- Annotated eCRF: For SAS programming, Database built up
- Database Testing: To meet the protocol and eCRF requirements
- Data Validation Plan (DVP): For data cleaning purpose (Detailed description of data validation check)
- Edit check implementation and testing: To check (Validate the response as per protocol requirement) the discrepancy of the data through system
- eCRF training to site personnel
- Live site creation and project access rights
- Data entry at the site
- Source Data Verificaton at site, if required
- Data Cleaning by CMD: Query generation and resolution
- Medical coding-CONMED
- Self Evident Correction e.g. Misspelling
- Ad hoc report of project status to sponsor and site
- Manual review: Consistency, Plausibility, Range check, Spelling error checks
- Mockrun: To identify the obvious data error, Unusual data pattern
- Database Audit: To Measure the data quality and to ensure the practice followed
- PI’s Authentication
- Database lock: To release the data for statistical analysis
CDM & Biostatistics Services
- ECRF/eCRF designing
- CRF annotation as per CDISC
- Data Management Plan
- Database designing and UAT with dummy data
- Data validation & Query resolution
- External data upload & cleaning
- TMF Management
- EDC Traning for the site personnel
- Sample size and Study Design
- Protocol inputs/review, SAP & mock shells
- Statistical analysis & reporting
- Customized tables, graphs and data listings
- Statistical interpretation of study results
- BA/BE Studies in multiple groups
- Scaled approach & replicate the design
- Two-stage design
- Pharmacokinetic & PD parameters
- Cost-effective (~ 60%)
- Locally available System
Biostatistics, Programming & Reporting
- FP / feasibility inputs
- Study Design
- Sample size calculations
- Protocol inputs
- Randomization Generation
- Pharmacokinetic Sampling, as applicable
- To prepare a statistical analysis plan, as applicable
- Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Analysis
- Generation of Tables, Listings and Graphs
- Statistical Analysis
- Scientific inputs to the study conclusion
- Report preparation
- To provide scientific inputs to sponsor or regulatory query related to the study data or conclusion
Expertise in Special Type of Data Analysis
- In vitro data analysis for Equilibrium Binding & Kinetic Binding (e.g. Sevelamer, Colesevelam)
- Statistical testing for data on Particle size analysis (e.g. Azacitidine Inj.)
- Two-stage study design (Adaptive study / Group Sequential approach)
- Data Analysis based on latest OGD requirements like Scaling approach for NTI drug (e.g. Tacrolimus)
- CDISC, ADaM and SDTM compliant dataset preparation
- Data analysis for Phase-3 trials involving Non-inferiority, Superiority and Therapeutic / Clinical equivalence comparisons
- Involving a single dose, multiple-dose with different study designs, over 750 studies have been designed on the EDC system
Medical Innovation Group – Core Activities
- Focus on Innovative thinking for existing and novel drug development programs by application of pharmaceutical intelligence employing concepts of applied pharmacology.
- Identify strong unmet needs across the therapeutic area.
- Mapping global trends through the competitive landscape, market research inputs, ‘SWOT’ analysis and understanding regulatory framework to develop detailed innovative proposals (Phase II/III ) and road map for novel drugs/dosage forms development.
- National and International KOL Engagement and Advisory Board Building.
- Preparation and Review of Scientific Advise Briefing package for global Regulatory Authorities.
- Due diligence for global in-licensing proposals/M&A plans.
- Evidence based holistic approach for catering to modern healthcare needs.
Basis of identification of ‘New Product Development’ concept:
- NDDS Platform
- Truly rational FDCs exploiting principles of synergy for additive and supra-additive therapeutic yield
- Looking for newer yet promising indications of already marketed products