|
Trial Management, Final Report, Close Out |
|
Project teams are highly trained, up to date, well prepared for each study in with regard to the study's study goals, plans, and relevant scientific and medical background. Communication with the sponsor’s team as well as continuity and oversight of study teams are a top priority.
TMI’s staff supplements the investigative site support staff, which can be under resourced in India relative to western norms. Our model enables greater productivity and quality than the importation of a western model.
We help ensure that inclusion/exclusion criteria are strictly met, and that all activities are compliant with the protocol. Our staff helps the investigators build quality into their processes and if any issues or challenges arise we identify them immediately and bring proposed solutions to the sponsor for consideration.
Among the services provide are:
* Comprehensive Site Management
* Patient Accrual Management
* Quality assurance and regulatory compliance
* Clinical monitoring, with TMI employees on-site
* Case report form (CRF) design, finalization, and printing
* Clinical supply management
* Adverse event reporting and follow-up; regulatory severe adverse event reporting
* Data Management
* Generation of the final study report
* Study closeout
* Pharmacokinetic sampling, storage, and export
|
Services 
