Your Trusted Partner For Clinical Research and Pharmacovigilance

CLINICAL TRIALS

Clinexel is a full-service CRO 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) are Full-Time Equivalents (FTEs), working from Clinexel office.

CLINICAL TRIALS PROJECT MANAGEMENT

• Clinical Trial Project Planning Including Feasibility Assessment, Regulatory Strategy, and Financial Planning
• Selection of Countries & Clinical Trial Applications to Competent Authorities
• 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

CLINICAL TRIALS MONITORING SERVICES

• Site Initiation Visits​
• Clinical Trial Monitoring
• Investigational Product Management and Accountability
• Clinical Trial Supplies Management
• Resolving Data Queries
• Identifying Corrective Actions to Prevent Issue Recurrence and Preventive Actions to Avoid Deviations
• Study Close-out Visits

EXPERTISE

CLINEXEL Expertise Includes

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

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

CLINEXEL is a professionally managed Company, a CRO is led by experts with experience in leadership positions in pharma and biotech companies.

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Our experts will be happy to speak with you to understand your challenges and propose optimum cost-efficient solution.
Write to us at : info@clinexel.com

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