Vaccine & Drug Trial Support Services
We help companies avoid making critical drug development mistakes
Our Expertise
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Strategic Consulting
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Regulatory Submission Process
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Drug Development
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Project Management
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Clinical Monitoring
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Clinical Trial Plan and Implementation
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Medical Writing
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Safety Surveillance Expertise
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Clinical Trial Data Collection & Analisis
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Training & awareness
Support at every stage of your project
The TLV international team offers pharmaceutical and biotechnology companies high value-added skills in pharmacovigilance, regulatory affairs, quality, clinical studies, biometrics and market access.
TLV international trading can intervene from the conception of the project with the bibliographic research, the writing of the protocol, the creation of the eCRF and the regulatory submissions until the writing of the final clinical report in ICH format.
Regulatory
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Development of the regulatory strategy and submission plan to support “Global” registrations
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Explore the possibility of pursuing expedited pathways
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Prepare and review regulatory agency meeting requests and packages
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Attend regulatory agency meetings
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Prepare for and participate in FDA Advisory Committee meetings
Statistical
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Ensure that the clinical trial's statistical design will meet the intended objectives
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Evaluate potential of implementing Adaptive Design
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Approaches & Planning
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Run clinical trial simulations
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Perform predictive modeling
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Assist with primary and secondary endpoint selections
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Determine which statistical approach to use
Clinical & Medical
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Protocol design & clinical trial planning
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Assist with initial indication selection, incorporating “Quick to POC” and commercial considerations into study designs
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Develop Key Opinion Leaders (KOLs) and Advisory Panel Networks
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Assist with preparation for and provide representation at meetings with regulatory agencies
Planning & Conduct
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Develop the clinical trial design
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Determine sample size calculations
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Write, edit or review protocols
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Design electronic Case Report Forms (eCRFs)
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Write Statistical Analysis Plans (SAP) or Interim analysis plans
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Draft regulatory agency, board meeting, or investor presentations of the clinical development, regulatory and / or statistical plans
Personalized support, adapted to your project
From TLV international trading, we provide you with the knowledge, foresight, and expertise to make informed strategic decisions to accelerate your medical therapies along the drug development pathway.
Pharmacovigilance
Regulatory Affairs
Clinical studies
Quality
Market Access
Data Science
Biometrics