Overview

We possess the scientific expertise and operational excellence to successfully execute the most challenging studies.

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 including early phase studies
• 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 methods for clinical PK, BA/BE and TDM studies
• Development, validation and transfer of bioanalytical methods for biologics, biotechnology products and small molecules
• 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

Medical Writing

• Investigator brochure
• Clinical study protocols
• Informed consent forms
• Study assessment questionnaires
• Patient dairies
• Clinical study reports – Phase I to IV
• Abstracts and manuscripts
• Clinical overview and clinical summary
• DSMB manuals

Medical Monitoring

• Protocol review
• Investigational brochure review
• Review of Case Report Forms (CRF)
• Review of Informed Consent Forms (ICF)
• Handling protocol deviations
• Providing protocol waivers, wherever acceptable
• Medical review of statistical and clinical reports
• Providing inputs during Feasibility Assessment

Safety Management

• AE and SAE case receipt, coordination and processing
• Medical review of AEs and SAEs
• Verification of AE coding
• Preparation of safety narratives
• Perform expedited safety reporting
• Reconciliation of SAEs
• Reconciliation of safety database with CRFs

Pharmacovigilance

• Set up and maintenance of global safety database
• Collection, evaluation, analysis and reporting of safety information
• Literature search in compliance with regulatory requirements
• Medical review of case reports
• MedDRA coding
• WHO DDE coding
• Preparation of safety narratives
• Preparation and submission of Periodic Safety Update Reports (PSURs) to regulatory authorities
• Preparation and submission of expedited reports to regulatory authorities

Clinical Data Management & Biostatistics

• CRF design
• Electronic Data capture screens
• Query/discrepancy management
• Medical coding
• Serious Adverse Event reconciliation
• Statistical inputs for protocol design
• Sample size calculation
• Generate randomization schedule
• SAS coding
• Statistical analysis, tables, figures and report
• Support DSMB/DSRB conduct an interim analysis

Regulatory Services

• Regulatory approvals for early phase, BA/BE studies and Phases I-IV clinical trials
• NOC to export biological samples for testing
• Approval of Import license of drugs/drug substances
• Safety reporting
• Product registration for marketing approval
• Regulatory dossier compilation, including CTD and eCTD format