It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

Reputed Client of China


Scientific Affairs & Innovation

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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

Focus Activites
  • Timelines Setup
  • Study-related DM docs
  • KoM / IM
  • SAP preparation
  • Protocol Training
  • Site/User Creation
  • Database setup
  • eCRF training to the monitors/site personnel
Navigation Phase
  • Data Validation
  • Periodic Updates
  • Data Validation
  • Resolution of queries
  • IT support on eCRF
  • Data Status Tracking
  • SAS Programming
Close out Phase
  • 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 System (CDMS)

Clinical Data Management System

Clinical Data Management Task

Study Setup
  • 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
Study Contact
  • 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
Study Close Out
  • 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

CMD Study
  • 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
Beznet Benefits
  • 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

Looking for a Globally Proven Research Partner?

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