Project Management

Project Management is our major competence. KlinEra owns a set-up that is grounded upon project managers and skilled investigators with enormous experience who have the ability to efficiently lead projects from the start till end. KlinEra Project Managers have extensive experience in the conducting complex clinical trials, which is essential to study success. Our Project Managers are reinforced by defined and verified methodology and processes that make sure the execution of study is done within defined Quality, Budget and Timeline.

Project Planning, Training and Kick-off:

Organizing and conducting comprehensive project kick-off meeting with study team, Global project design development, Development of Protocol and other training materials and conduct training sessions.

Project Oversight and Reporting:

Manage the project timelines and budget. Track study activity on weekly/biweekly basis and reporting throughout project duration to the sponsor.

Vendor Management

KlinEra performs Vendor selection, qualification, contracting, and takes care of payment administration. End-to-end management of critical study vendors (e.g. drug depot, lab, IRB/EC, eTMF, EDC & RTSM (Randomization and Trial Supply Management)