General
Pesticides/Agricultural Chemicals
Commercial Chemicals
Food Additives and Dietary Supplements
Medical Devices
  Pharmaceutical, Biological and Biotechnology Products
      Regulatory Services
      Drug Development
      Project Management
      CMC and Compliance
      Bioanalytical and Laboratory Services
      Preclinical Assessment and Management
      Phase I Drug Development
      Phase II-IV Drug Development
     Clinical Monitoring
Veterinary Drugs

Throughout the duration of the project, Mandava Associates offers the singular focus of a dedicated team for consistent effective interaction with study sites. Our clinical monitor is responsible for seamless communications with your organization. Some of the services that are offered but not limited to are:

      Provide monitor(s) who is qualified by experience and training for a given project
      Assure investigator meets general responsibilities listed under 21 CFR
      Evaluate and make recommendations regarding investigators/testing sites
      Conduct pre-study site inspections
        acceptability of the site
        review the protocol and data capture forms with the investigator
        finalize contract/protocol
        assist with training of technical personnel
      Site visits during the trial
      Spot check critical data during site visits
      Provide phone support for investigator questions
      Assist investigators with finalizing reports

 

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