Your Trusted Partner For Clinical Research and Pharmacovigilance

CLINICAL TRIALS

CLINEXEL provides end to end services for conducting clinical trials starting from study design, feasibility studies and site selection, preparation of protocol and other essential documents, logistics and project management, clinical trial applications and approval, clinical trial monitoring, data management, statistical analysis and preparation of clinical study report.

CLINICAL TRIALS PROJECT MANAGEMENT

  • Clinical trial project planning including feasibility assessment, development of regulatory strategy and financial planning.
  • Selection of countries & Clinical Trial Applications to Competent Authorities for approval.
  • Vendor Selection and logistics Management.
  • Site Selection & qualification.
  • EC dossier preparation, submission and approvals.
  • Efficient Patient Recruitment Strategies.
  • Investigator contract development and grant negotiation.
  • Site set-up.
  • Investigator meeting.
  • DSMB set-up.
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CLINICAL TRIALS MONITORING SERVICES

  • Site initiation visits.
  • Clinical Trial Monitoring by experienced team of CRAs.
  • Receipt, processing, medical assessment and reporting of SAEs.
  • Investigational Product Management and Accountability.
  • Clinical Trial supply management.
  • Resolving Data Queries.
  • Reporting of Deviations and supporting the site for Corrective and Preventive action(CAPA).
  • Study Close-out visits.

SERVICES

  • Project Management
  • Study Planning
  • Feasibility
  • Site Selection
  • Protocol & Other Essential Documents
  • Regulatory Dossier Preparation
  • Vendor Selection-lab, electronic data capture, Warehouse
  • EC Dossier & Approvals
  • Site Monitoring- Siv, Smv, Scv
  • Study Management & Site Management
  • Safety Monitoring
  • Data Management & Query Resolution
  • Statistical Analysis & Clinical Study Reports

EXPERTISE

High Quality Data Generation

    • Strong Project Management
    • Accurate Feasibility -accurate Prediction
      of Recruitment, Timelines, Cost
    • Well Versed with GCP & Regulations
    • Strong Site Connect
    • Experienced CRAs
    • Clinical Trials Of All Phases-
    • Phase I To IV & First in Human
    • Pharma, Biologics & Medical Devices
    • Global Clinical Trials
    • Across Therapeutic Areas