TTA provides services that include but are not limited to the following:

Study Start-Up
        Protocol Development
        Feasibility studies
        Identification and recruitment of qualified study sties and investigators
        Review and negotiation of study budgets and research agreements
        Regulatory document collection and tracking
        Clinical site monitoring and data collection
        Good Clinical Practice site compliance
Data Management
        Case report form design
        Data collection tolls
        Assessment of database platform
Clinical Project Management
         Customized tracking of clinical trials, subject and/or site status
         Investigator meetings
         Project oversight to timelines
         Organization and oversight of Data Safety Monitoring Boards
Medical Writing
         Medical writing of protocols, investigator brochures, regulatory submissions, applications,                              clinical study reports, SOP's, clinical trial support documents, serious adverse event
         narratives, grants and publications, PLAs, data safety monitoring, etc.
Report Submissions
          IND submissions and updates
          Institutional Review Board submissions and regulatory documents tracking
Quality Assurance
          Clinical site audits
          Internal Client Audits
          Vendor Audits
          Database, report and file audits
Miscellaneous Consulting
           Project development
           Regulatory submissions to FDA and IRBs


Maria T. Berkheimer, President
6807 New Cut Road
Kingsville, MD 21087

Contact number:


Our commitment is to provide quality services by offering qualified, experienced, and highly professional consultants. Our project team members provide insight into successful clinical development through proactive project management, quality of service, and consistent dedication throughout the duration of assigned projects.  The Total Approach is the right choice for the biotechnology and pharmaceutical companies in need of clinical assistance.