Arun Kumar

Executive_Clinical Data Management

Role: Executive at Insignia Clinical Services
Location: New Delhi, IN
LinkedIn followers: 500 followers

Manufacturing & ProductionView LinkedIn profile

Experience

Executive
Insignia Clinical Services
Oct 2023 — Present · New Delhi, IN
Database Design & Management, Regulatory Compliance, EDC/IWRS Systems (Clinion, Clindox, Octalsoft), eCRF Designing, Data Validation & Cleaning, Clinical Data Review, SOP Adherence & Quality Assurance, User Acceptance Testing (UAT), CRF Design and Development, Query Management, Data Extraction, DMP, DVP, Study design specifications, URS, MRL/Kit code list, Database lock & freeze activities, Training, Edit checks programming, Troubleshoot, EDC setup, sites creation, Designing annotated CRFs, CDISC standards, permission assignment and users access management.

Contact information

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Work email
•••••@insigniacs.com
Personal email
•••••@•••••.com
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Current company

Insignia Clinical Services

Pharmaceutical Manufacturing · 58 employees · Founded 2010 · New Delhi, India

Insignia Clinical Services (ICS) is a leading Indian Contract Research Organization, headquartered in New Delhi, India; Currently servicing clients from Pharmaceutical, Biotechnology, Medical Device & In-Vitro Diagnostics, Cosmetics, Food & Health Supplements, Agrochemicals (Insecticides / Pesticides). ICS offers customized, innovative, timely managed and goal oriented solutions for requirements related to Regulatory Affairs, Clinical Trials (Phase I-IV), Non-Clinical Studies, Medical Writing & Pharmacovigilance. ICS delivers a complete spectrum of services for clinical trial and regulatory consulting throughout the product lifecycle from concept to commercialisation & beyond. ICS goes a mile ahead to support its clients by offering various Ancillary Services such as government affairs & liaisoning, distributor identification & qualification, regulatory intelligence, strategic out-licensing/in-licensing opportunities, which gives them strategic advantage to prevail over the competition. Our unique solutions are scalable & best fit for your different project requirements, whether you are a Multinational Company, Indian Manufacturer or Importer. REGULATORY AFFAIRS • REGULATORY STRATEGY & PROJECT PLANNING • REGULATORY SUBMISSION • IN-COUNTRY REPRESENTATION • REGULATORY INTELLIGENCE NON- CLINICAL SERVICES • NON-CLINICAL STUDIES • PERMITTED DAILY EXPOSURE • TOXICOLOGICAL RISK ASSESSMENT CLINICAL SERVICES • BIOSTATISTICS AND STATISTICAL PROGRAMMING • CLINICAL ANALYTICS • CLINICAL DATA MANAGEMENT • CLINICAL TECHNOLOGY • SITE SELECTION, INVESTIGATOR RECRUITMENT & PATIENT SERVICES • PROJECT MANAGEMENT • QUALITY ASSURANCE MEDICAL WRITING • REGULATORY WRITING • CLINICAL & NON-CLINICAL STUDY WRITING • PHARMACOVIGILANCE ANCILLARY SERVICES • GOVERNMENT LIAISONING • DISTRIBUTOR IDENTIFICATION & QUALIFICATION • MERGER & ACQUISITION

insigniacs.com

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