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
Monitoring
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
Services
.
Email:
Maria T. Berkheimer, President
6807 New Cut Road
Kingsville, MD 21087
Contact number:
410.592.6242
The TOTAL APPROACH, INC.
EXCEEDING THE EXPECTED
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.
