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Late Phase Trials (Phase IIB-IV)

Home Late Phase Trials (Phase IIB-IV)

ADVITY offers end-to-end support across Phase IIB to IV and PK/Clinical endpoint trials. Our expertise spans from regulatory writing to the delivery of final clinical study data and reports, all in strict adherence to regulatory standards. Additionally, we provide comprehensive safety reporting throughout the clinical trial process.

Extension

The clinical development team at ADVITY serve as an extension of your clinical program, sharing your commitment and values

Quality

Our rapid engagement and strategic thinking ensure more efficient start-up times and superior quality data across all phases of clinical trials (phase I to IV)

Integrity

We instill the motto "ADDING VALUE WITH INTEGRITY" as part of our daily routine, to emphasize our commitment to ethical clinical research

Comprehensive Services

  • Feasibility and Selection
  • Site set-up
  • Initiation
  • Recruitment Management
  • Staff Training
  • Logistic & administrative support
    • PK Kits handling
    • IP management
    • Biological sample shipment
    • Central lab management
  • Overall QC and QA services
  • Oversee data collection
  • Ensure regulatory compliance
  • Resolve data queries
  • Review source documentation and case report forms
  • CRAs are typically dedicated to one protocol at a time to maintain quality
  • Clinical Trial protocols
  • Case Report Forms (CRF/eCRF)
  • 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
  • RTSM
  • 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
  • Large molecule services
  • PK/PD/lmmunogenicity assay for Biosimilars or large molecules
  • Development and Validation of robust custom assays
  • Extensive LC-MS/MS experience
  • Signal Detection & Management
  • AE & SAE Case processing
  • DSUR /PSUR reports
  • MICC

Our Clinical sites network

We have an extensive clinical site network across India in the following therapeutic segments

Autoimmune

Dermatology

Endocrinology

Genitourinary

Antipsychotic

Oncology

Ophthalmology

Others

Digitalization - eDC

Clinical Site Management
  • Study administration
  • Role based access
  • Central Lab management
  • External Data Loaders
Clinical Monitoring
  • Patient visit scheduler
  • Data capture
  • Audit logs
  • Compliance monitoring
Clinical Project Management
  • Audit logs
  • Investigational Product management
Clinical Data Management
  • Data management
  • Report builder
Statistical Analysis Services
  • Data extraction (Inputs to Stats)
Clinical Vigilance Services
  • Case processing
  • Generation of submission ready files

Connect with our Director Clinical Services to discuss on your next project

Kalyan Reddy - Director Clinical
+91 40 69089999
bd@advityresearch.com