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Supporting clinical program at any phase or every phase – on the drug development continuum


  • Early Phase
  • Phase IIB - III
  • Late Phase
Early Phase
  • Patient PK Studies
  • PK/PD Studies
  • Clinical End Point study
  • Glucose Clamping Studies
  • Phase IIA Studies
Phase IIB - III
  • Providing end-to-end collaboration and services to support studies from Phase IIB to Phase III
  • Clinical Vigilance support
Late Phase
  • Phase IV studies
  • Observational studies
  • Investigator initiated trials
  • Interventional Studies
  • Pharmacovigilance & Patient Safety
  • Medical Writing Support
  • Bioanalytical Support – Small & Large Molecule analysis
  • PK, Stats & Data Management Support (Full Digital)

Comprehensive Solutions

  • Clinical Site Management
  • Clinical Monitoring
  • Medical Writing
  • Clinical Project Management
  • Statistical Analysis Services
  • Clinical Data Management
  • Bioanalytical Services
  • Clinical Vigilance Service
  • QA/QC Services
  • Other Services
  • 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

Therapeutic Areas

Our Extensive Clinical Sites Network


Diabetes & Endocrinology






Oncology & Haematology




Pulmonology & Respiratory






Obstetrics & Gynaecology & Womens Health Care



Our Differentiators

Know the challenges

Extensive experience in clinical research, we possess a comprehensive understanding of the drug development process

Flexible in business approach

Ready with resources to cater for the ever expanding requirement(s) of clients

Agility and Responsive

Team is agile and adapts quickly, able to pivot and change course

Technology Integration

Automation (online) of activities EDC, Data capturing, Patient IVRS & Analytical activities

Best people to the trials

Team is combine in-depth therapeutic knowledge with a passion for clinical research

Cost benefit

Our cost control mechanisms guarantee a positive cost-benefit without compromising the quality of data and compliance


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