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F2, Sri Lakshmi Nivas, Opp. Vikas Junior College, Sheela Nagar, Visakhapatnam, Andhra Pradesh, India. Mobile No: +91 8555998470
F2, Sri Lakshmi Nivas, Opp. Vikas Junior College, Sheela Nagar, Visakhapatnam, Andhra Pradesh, India. Mobile No: +91 8555998470
As a progressive company that is expanding globally, Clinanalytica is always on the lookout for talented technical and business professionals in several of its offices. If you are interested in submitting a resume please send an email to: info@clinanalytica.com hr@clinanalytica.com
Consultation/ Development of Regulatory strategy to support country-specific or worldwide registration Guidance and advice for optimized testing packages of nonclinical and clinical studies consistent with your vision and the applicable regulatory requirements. Target Product Profile (TPP) and Clinical Development Plan (CDP) preparation or review and critique Regulatory / industry intelligence using internal and external information […]
Clinanalytica has an expert team of with strong technical understanding of both Study Data Tabulation Model (SDTM) analysis Data Model (ADaM), corresponding implementation and Reviewers’ guides, CDISC terminologies and the related regulations. Creation of related documentation: SDTM annotated CRF, SDTM metadata, DEFINE.PDF, DEFINE.XML Creation of documentation related to ADaM: analysis level, dataset level, variable level, parameter […]
Our industry is data driven. You need expert programmers for proper study execution and monitoring. Clinanalytica clinical programming group is directly aligned with clinical data management and serves multiple cross-functions (like Clinical Operations, Clinical Science, and Safety). Clinanalytica solve complex problems and present you output that is easily integrated into your process. We follow a […]
Creation of core EDC development documents (like the EDC Development Plan, Study Database Specifications, Logic/Edit Check document, etc.) eCRF Design (in system or mock-ups) Annotated eCRFs User Acceptance Testing (UAT) for eCRFs, dynamics, and logic/edit checks Programming of logic/edit checks Data Import integrations Complete database output validation (forms to screens to database outputs) Standard and […]
Our CDM team will help you focus on the key variables that directly drive safety and efficacy analysis. We have closed hundreds of databases and our experience means you get the quality data outputs you need. Start-Up Services Protocol and Protocol Amendment Review Creation of Core Documents (Data Management Plan, Data Quality Plan, Communication Plan, […]
Clinical monitoring services are a key part of your study success. Our monitoring approach is developed with a strong partnership between clinical operations and clinical data management. With the success of Electronic Data Capture, the monitoring role has expanded. Our CRAs are both clinical and technical experts with EDC systems. Our monitors are trained in […]
The success of your study depends on competent project management. Our project management methodology follows closely with the Project Management Book of Knowledge mixed with our deep experience with managing clinical studies. We work with you from the initiation phase through study closeout. We will help you with Scope, Quality, Timelines, Budget, Resources, and Risks. […]