Medical Services

Venn Life Sciences employs licensed clinical research physicians with extensive experience in study design, protocol development, full study execution and medical support. Our medical experience spans across multiple therapeutic areas in both Pharma and Biotech.

Our medical monitoring services include:

• Training on Therapeutic Area / disease
• Training on Protocol and Project-specific safety
• Risk Assessment to reduce Screen Failure and Protocol Deviations Rates
• Developing of Project-specific Medical Monitoring Manuals
• Review of Study Documents (Protocol, CRF, ICF, Study Manual, Monitoring Plan, Safety Plan)
• Scientific and Medical Support to Project Teams and Sites
• Assessing Subject Eligibility
• Review of Protocol Deviations
• Medical Data Coding and Review
• Handling of Medical Queries from Sites or ECs regarding appropriate Interpretation and Application of the Study Protocol
• Participation in Data Review meetings
• Evaluation of SAEs on Expectedness and Relationship to the Study Drug
• Writing of Individual Case Safety Reports (Narratives)
• Medical Review of Listings, Tables and Figures
• Participation in Data and Safety Monitoring Board
• Evaluation of the Results of the Statistical Analysis
• Preparation and Review of the Final Clinical Study Report
• Development of Key Opinion Leader Network
• Site Selection and Enrollment Enhancement Strategies

Our medical expert services covers:

• Support to regulatory strategy planning
• Participation in Clinical Development Plan preparation
• Participation in advisory boards
• Participation in study design elaboration and protocol development (Definition of study patient population, development of Study Hypotheses…)
• Provide medical expertise in the development and/or review of all clinical-trial related documents