• Feasibility and Selection
• Site set-up
• Initiation
• Recruitment Management
• Staff Training
• Logistic & administrative support:
1. PK Kits handling
2. IP management
3. Biological sample shipment
4. Central lab management

• Overall QC and QA services
• Oversee data collection
• Review source documentation and case report forms
• Ensure regulatory compliance
• Resolve data queries
• CRAs are typically dedicated to one protocol at a time to maintain quality

• Clinical Trial protocols
• Case Report Forms (CRF)
• Informed Consent Documents (ICD)
• Investigator Brochure (IB)
• Patient Information Sheets (PIS)
• Patient Diaries (PD)
• Clinical & Non Clinical overview reports
• Clinical Study reports
• Safety Aggregate reports

• Clinical Study Contracts & Budgets, management of SOW and Project Timelines
• Coordinate with sites and competent authorities on behalf of Sponsor
• Trial, Site, Patient Management, and CTMS
• In-house and On-site Monitoring Management
• Inspection & Audit Readiness, CAPA, Risk Assessment and Mitigation Plans

• Statistical consulting on study design
• Statistical analysis and reporting
• Development of the statistical analysis plan
• Sample size and power calculations
• Study randomization schedule
• Writing statistical sections of the protocol & reports
• Tables, listings, figures and annexures
• Development of CDISC, SDTM, and ADaM datasets with documentation and validation as per the applicable regulatory requirements

• Electronic case report form (eCRF) design
• Database design and study setup
• Medical coding to industry standards
• Data validation and query resolution
• Management and reconciliation of third-party data
• CDISC study data tabulation model mapping and consolidation

• Extensive experience with both small & large molecules
• Excels at creating custom solutions for clients’ most challenging problems/methods
• Pharmacokinetic sample analysis
• PK/PD/Immunogenicity assay for Biosimilars or large molecules
• Development and Validation of robust custom assays
• Quality large molecule services
• Extensive LC-MS/MS experience

• Signal Detection & Management
• AE & SAE Case processing
• DSUR /PSUR reports

In Process Audits

• Investigator files / site audits
• Trial master file audits
• Database audits
• Statistical report audits
• Clinical study report audits
• Vendor audits

Retrospective Audits

• End of study audits will be conducted after the last subject last visit at the study sites or before finalizing the report

For-cause Audits/GAP analysis

• For-cause Audits/GAP analysis For-cause audits will be performed whenever any issues arise and/or when regulatory authorities or sponsors raise any concerns, GAP analysis is required a

• PK KITS management
• Investigator contract management & Payments
• Archival Support
• Regulatory consultation
• Publication support