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