Your Trusted Partner For Clinical Research and Pharmacovigilance

BEST CLINICAL TRIALS ORGANIZATION

CLINEXEL is the Best clinical trials organization offering full-service CRO capabilities with in-house Full-Time Equivalents (FTEs) and qualified vendors providing services from protocol preparation, site selection, regulatory and EC approvals, clinical monitoring, Clinical Data Management (CDM) until Clinical Study Report (CSR) writing. CLINEXEL employees Clinical Research Associates (CRAs), Monitors, Project Managers (PMs), and Medical Writers (MWs) as Full-Time Equivalents (FTEs), working from the Clinexel office.

CLINEXEL offers full-service CRO capabilities, providing Clinical Research Services, with in-house Full-Time Equivalents (FTEs) and qualified vendors. 

CLINEXEL expertise includes Strong Project Management & High-Quality Clinical Trials Monitoring Services. Team at CLINEXEL is Well Versed with ICH-GCP & all applicable Global Regulations to conduct Global Clinical Trials in all phases [Phase I to Phase IV & First in Human Studies], with Small Molecules, Biologics, Biosimilars and Medical Devices across various Therapeutic Areas.

CLINEXEL has Strong Clinical Trial Site Connect and provides Accurate Clinical Trial Feasibility– Precise Identification, Accurate Prediction of Recruitments, Timelines & Costs involved.

CLINEXEL employees – Clinical Research Associates (CRAs), Trial Monitors, Medical Monitors, Project Managers (PMs), and Medical Writers (MWs) working as Full-Time Equivalents (FTEs), are a talented group with shared vision of contributing to the clinical development of safe and effective therapeutics. 

CLINICAL TRIALS PROJECT MANAGEMENT

  • Clinical Trial Project Planning – Feasibility Assessment, Regulatory Strategy and Financial Planning
  • Selection of Countries & choice Clinical Trial Applications to Competent Authorities
  • Site Identification, Selection & Qualification
  • Investigator Contract Development and Grant Negotiation
  • Vendor Selection and Logistics Management
  • Site Set-Up & Investigator Meeting
  • EC Dossier Preparation, Submission and Approvals
  • Effective Strategies for Efficient Patient Recruitment 
  • Diligent Planning of the Clinical Trial coordination including:
    • Regulatory & Ethics Committee documentation
    • Translation of patient-facing documents to vernacular languages
    • Logistics of local & central clinical laboratories
    • Custom clearance of trial supplies (import) and patient samples (export)
    • Re-packaging, labelling & distribution to the trial sites
    • Warehouse facilities
    • Appropriate Archival locations

CLINICAL TRIALS MONITORING SERVICES

  • Site Initiation Visits
  • Site Staff Trainings
  • Clinical Trial Supplies Management
  • Investigational Product Management and Accountability
  • Clinical Trial Monitoring
  • Medical Monitoring
  • Resolving Data Queries
  • Study Close-out Visits

EXPERTISE

CLINEXEL Expertise Includes

  • Strong Project Management
  • High-Quality Data Generation
  • Well Versed with GCP & Global Regulations
  • Strong Site Connect
  • Accurate Feasibility– Accurate Prediction of Recruitments, Timelines, Cost
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EXPERIENCE

CLINEXEL Team has Experience with

  • Clinical Trials of all Phases
  • Phase I to Phase IV and First in Human Studies
  • Small Molecules, Biologics, Biosimilars and Medical Devices
  • Global Clinical Trials
  • Across Therapeutic Areas

ISO Certified

CDSCO Certified

Memeber of AICROS

Best Full Service CRO Clinical Trials Organisation 2023 – South Asia

Best Full Service CRO – Asia 2024 Excellence Award for Medical Writing Services – Asia 2024