Our Competence Areas

Leveraging our extensive experience and expertise across various clinical research domains

Phase I, II, and III Clinical Trials

With your product showing promise, we support your development programs through full-service solutions. We provide detailed Feasibility Studies, Regulatory support, and Translations, enabling us to work together to create a healthier world.

  • Detailed feasibility studies
  • Regulatory compliance
  • Safety monitoring
  • Efficacy demonstration
  • Benefit-risk evaluation

Phase IV/Post Marketing Surveillance

Supporting your research objectives through monitoring safety, demonstrating effectiveness, and evaluating benefit-risk for market access.

  • Retrospective data collection
  • Health outcomes/economics
  • Effectiveness comparatives
  • Safety outcomes
  • Patient-reported outcomes
  • Patient registry studies

Rescue Studies

We provide seamless assistance when problems arise during ongoing studies, working alongside other CROs using established processes.

  • Quick site initiation
  • Enrollment target achievement
  • Quality data collection
  • Regulatory approval management
  • Site agreements handling
  • Logistics coordination

Biosimilar Studies

Comprehensive solutions for biosimilar drug development, with expertise in managing critical aspects of biosimilarity analysis.

  • Bio-similarity analysis
  • Extrapolation studies
  • Immunogenicity assessment
  • Operational management
  • Regulatory compliance

Ayurvedic / Herbal Product Studies

Experienced in conducting ayurvedic/herbal consumer products clinical trials with successful track record.

  • Subject recruitment
  • Patient retention
  • Timeline management
  • Quality assurance
  • Data collection

Audit & Inspection

We take pride in our proven track record of successfully navigating regulatory inspections and sponsor audits across multiple clinical studies. Our commitment to compliance, data integrity, and patient safety is reflected in the outcomes of these inspections.

  • FDA Inspection: Completed a U.S. FDA inspection at one of our clinical trial sites for a diabetes study, with no positive findings and no major findings
  • The European Medicines Agency (EMEA) inspected a diabetes study at one of our investigator sites, and there were no major findings. Our team received commendations for their work
  • Sponsor & CRO Audits: Over 10 Sponsor and CRO audits were conducted across various therapeutic areas and study phases all of which were completed with high compliance standards maintained