Clinigene International Ltd.

Clinigene International Ltd. Overview

Company Overview
Clinigene International Limited is a full-service Clinical Research Organization that partners with global pharmaceutical and biotechnology companies in their clinical development programs. We have the capabilities to evaluate safety and efficacy of new drugs and therapies for a wide range of therapeutic indications with efficiency and complete confidentiality. We focus on quality and add value to our clients’ clinical development programs by evolving various strategies to ensure timely execution of clinical projects and cost-competitive services.
We are conduct bioequivalence, medical device, phase I-III studies and post-market evaluations in an international GCP and ICH compliant environment. Our US office is located in Iselin, NJ and our clinical facility is based in Bangalore, India. We provide a comprehensive offering of clinical services for clients globally. Clinigene has vast clinical trial management expertise in conducting complex clinical programs ranging from biological and biotechnology products, small molecules, vaccines and device projects. We have been audited by several prospective and current international clients as well as independent auditors. This has ensured robustness of systems and processes adopted in Clinigene.

Services Overview:

Regulatory Services
· Regulatory approvals for BA/BE studies and Phase I-IV clinical trials
· NOC for export of biological samples for testing
· Approval of Import license of drugs
· Safety reporting
· Product registration for marketing approval
· Regulatory dossier compilation, including CTD and eCTD format
· Strategies on global CTD and eCTD regulatory submissions that conform to FDA and ICH guidelines

Clinical Development
· Conceptualization of study design
· Medical writing
· Medical monitoring
· Safety reporting

Human Pharmacology Unit
· Protocol design and review
· Recruitment and screening of healthy volunteers
· Protocol approvals by Independent Ethics Committee (IEC)
· Execution of complex study designs
· AE monitoring and reporting
· Report preparation

Bioanalytical Research Laboratory
· Development and validation of bioanalytical methods for analysis of drug(s) and/or active metabolite(s) in biological matrices and application of method for clinical PK, BA/BE and TDM studies
· Development, validation and transfer of bioanalytical method
· Adoption and partial validation of the bioanalytical methods transferred by sponsor
· Development of protocols for method development, method validation and bioanalytical study
· Preparation of customized analytical report ready for regulatory submission

Central Laboratory
· Supports Phase I – IV single centre and multicentric trials
· Safety test requirements for Pilot and Pivotal BA/BE/PK studies
· New assay development & validation
· Diagnostic device validations
· Global logistics and sample management
· Project management
· Kit Building
· Data management customized to meet the requirements of the sponsors

Clinical Operations
· Study management
· Site management
· Clinical monitoring
· Clinical trial supply management
· Vendor management

Clinical Data Management & Biostatistics
· Statistical inputs for protocol design
· Sample size calculation
· Generate randomization schedule
· Case Report Forms (CRF) design
· Electronic Data capture screens
· Query management
· Serious Adverse Event reconciliation
· Medical coding
· SAS coding
· Statistical analysis, tables, figures and report